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The Comeback Study

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ClinicalTrials.gov Identifier: NCT03691987
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : February 19, 2019
Sponsor:
Collaborators:
The Research Council of Norway
Quadram Institute Bioscience
Umeå University
Cornell University
Information provided by (Responsible Party):
University Hospital of North Norway

Tracking Information
First Submitted Date  ICMJE September 10, 2018
First Posted Date  ICMJE October 2, 2018
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE February 15, 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2019)
Change in individual global Fatigue Severity Scale score. [ Time Frame: Proportion of participants with change from baseline in global Fatigue Severity Scale score at 3 months after FMT ]
Fatigue Severity Scale (FSS) is a self-reported, 9-item fatigue scale. Participants rate all 9 items on a 7-point Likert scale (1-2-3-4-5-6-7) depending on how appropriate they felt the statement applied to them over the preceding week. The total score is calculated by adding up the answer from each item and divide by 9. Lower scores indicate better outcomes. Maximum score is 7. In an intention to treat analysis we will categorize participants as responders/non-responders, defining responders as decrease of more than 1,2 to the total baseline score in the FSS at 3 months post FMT by Chi Square. Baseline score will be the average of the two scores from the screening period. Missing values will be regarded as non responders
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
Change in individual global Chalder Fatigue Scale (CFS) score. [ Time Frame: Proportion of participants with change from baseline in global Chalder Fatigue Score at 3 months after FMT ]
CFS is a self-reported, 11-item fatigue scale. Participants rate all 11 items on a 4-point Likert scale (0-1-2-3) with a maximum total score of 33. Lower scores indicate better outcomes. In an intention to treat analysis we will categorize participants as responders/non-responders, defining responders as decrease of 25% to the total baseline score in the Chalder Fatigue Scale at 3 months post FMT by Chi Square. Baseline score will be the average of the two scores from the screening period. We will apply last value forward if missing time points
Change History Complete list of historical versions of study NCT03691987 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2019)
  • Change in individual global Fatigue Severity Scale score. [ Time Frame: Proportion of participants with change from baseline in global Fatigue Severity Scale score at 12 months after FMT ]
    In an intention to treat analysis we will categorize participants as responders/non-responders, defining responders as decrease of more than 1,2 to the total baseline score in the FSS at 3 months post FMT by Chi Square. Baseline score will be the average of the two scores from the screening period. Missing values will be regarded as non responders
  • Change in individual global Fatigue Severity Scale score by repeated measures [ Time Frame: Change in Fatigue severity scale by repeated measures from baseline, 1, 3, 6, 9 and 12 months ]
    In a repeated measure ANOVA we will assess change in Fatigue Severity Scale using treatment group (donor FMT and placebo), sex and donor with interactions as predictors. Non-significant terms will be removed. Then, susceptibility to infections, concurrent functional GI disorder, CFS/ME severity rating, use of antibiotics during study period, age, change in diet, use of food supplements and probiotics will be tested for confounding effects. We will apply last value forward for missing values.
  • Change in global score by the SF36. [ Time Frame: Change from baseline global SF36 Score at 3 months after FMT ]
    The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. By an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) we will compare change in global score. We will apply last value forward for missing values.
  • Change in subscale score by the SF36. [ Time Frame: Change from baseline in subscale SF36 Score at 3 months after FMT ]
    The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. By an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) we will compare change in subscale scor. We will apply last value forward for missing values.
  • Change in global score by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Change from baseline in global RBANS score at 3 months after FMT ]
    RBANS is a neuropsychological assessment that consists of ten subtests which give scores to five domains: Immediate memory, visuospatial/constructional ability, language, attention and delayed memory. We will explore the FMT effects on RBANS by an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) comparing change in global scores. We will apply last value forward for missing values.
  • Change in subscale score by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Change from baseline in subscale RBANS score at 3 months after FMT ]
    RBANS is a neuropsychological assessment that consists of ten subtests which give scores to five domains: Immediate memory, visuospatial/constructional ability, language, attention and delayed memory. We will explore the FMT effects on RBANS by an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) comparing change in subscale scores. We will apply last value forward for missing values.
  • Change in global score by the Hospital Anxiety Depression Scale (HADS) [ Time Frame: Change from baseline in global HADS score at 3 months after FMT ]
    HADS is an instrument with 14-items for detection of depression and anxiety in hospitalized patients. Scores range from 1-21 interpreted as: normal (0-7), mild (8-10), moderate (11-14), severe (15-21). Subscales for anxiety (HADS-A) and depression (HADS-D) is also defined. We will explore the FMT effects on HADS by an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) comparing change in global score. We will apply last value forward for missing values.
  • Change in subscale score by the Hospital Anxiety Depression Scale (HADS) [ Time Frame: Change from baseline in subscale HADS score at 12 months after FMT ]
    We will explore the FMT effects on HADS by an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) comparing change in subscale scores. We will apply last value forward for missing values.
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Baseline to end of follow up at 12 months after FMT ]
    Participants will be screened for adverse events from the time of informed consent through the end of the trial. In case of an identified adverse event, this will be recorded and described in the CRF
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • Change in global score by the Chalder Fatigue Scale [ Time Frame: Change from baseline in global Chalder Fatigue Score at 1, 3, 6, 9 and 12 months after FMT ]
    We will explore the FMT effects on Chalder Fatigue Scale by repeated measures ANOVA using treatment group (donor FMT and placebo), sex and donor with interactions as predictors. Non-significant terms will be removed. Then, susceptibility to infections, concurrent functional GI disorder, CFS/ME severity rating and use of antibiotics during study period, age, change in diet, use of food supplements, and probiotics will be tested for confounding effects.
  • Change in subscale score (physical and mental fatigue) by the Chalder Fatigue Scale [ Time Frame: Change from baseline in global Chalder Fatigue Score at 1, 3, 6, 9 and 12 months after FMT ]
    We will explore the FMT effects on Chalder Fatigue Scale by repeated measures ANOVA using treatment group (donor FMT and placebo), sex and donor with interactions as predictors. Non-significant terms will be removed. Then, susceptibility to infections, concurrent functional GI disorder, CFS/ME severity rating and use of antibiotics during study period, age, change in diet, use of food supplements, and probiotics will be tested for confounding effects.
  • Change in global score by the SF36. [ Time Frame: Change from baseline global SF36 Score at 3 months after FMT ]
    The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. By an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) we will compare change in global score
  • Change in subscale score by the SF36. [ Time Frame: Change from baseline in subscale SF36 Score at 3 months after FMT ]
    The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. By an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) we will compare change in subscale score
  • Change in global score by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Change from baseline in global RBANS score at 3 months after FMT ]
    RBANS is a neuropsychological assessment that consists of ten subtests which give scores to five domains: Immediate memory, visuospatial/constructional ability, language, attention and delayed memory. We will explore the FMT effects on RBANS by an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) comparing change in global scores
  • Change in subscale score by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Change from baseline in subscale RBANS score at 3 months after FMT ]
    RBANS is a neuropsychological assessment that consists of ten subtests which give scores to five domains: Immediate memory, visuospatial/constructional ability, language, attention and delayed memory. We will explore the FMT effects on RBANS by an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) comparing change in subscale scores
  • Change in global score by the Hospital Anxiety Depression Scale (HADS) [ Time Frame: Change from baseline in global HADS score at 3 months after FMT ]
    HADS is an instrument with 14-items for detection of depression and anxiety in hospitalized patients. Scores range from 1-21 interpreted as: normal (0-7), mild (8-10), moderate (11-14), severe (15-21). Subscales for anxiety (HADS-A) and depression (HADS-D) is also defined. We will explore the FMT effects on HADS by an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) comparing change in global score
  • Change in subscale score by the Hospital Anxiety Depression Scale (HADS) [ Time Frame: Change from baseline in subscale HADS score at 12 months after FMT ]
    We will explore the FMT effects on HADS by an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) comparing change in subscale scores
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Baseline to end of follow up at 12 months after FMT ]
    Participants will be screened for adverse events from the time of informed consent through the end of the trial. In case of an identified adverse event, this will be recorded and described in the CRF
Current Other Pre-specified Outcome Measures
 (submitted: September 27, 2018)
  • Engraftment of donor microbiota [ Time Frame: 3 months after FMT ]
    Comparison between baseline profile, post FMT and donor profile will show if engraftment of donor mikrobiota parallels clinical response to active FMT. To assess fecal gut microbiota composition, morning stool samples will be obtained at baseline and three and twelve months after FMT. Participants will collect their first morning bowel movement in a 120ml container for storing in their home freezer (-20C). Two-four weeks after, samples will be collected from participants home and stored on dry ice during transport until freezing at -80°C at the University Hospital of North Norway Harstad. Fecal analysis will be done by NextSeq500 allowing for enhanced metagenomics (prokaryote and viral) sequencing.
  • Engraftment of donor microbiota [ Time Frame: 12 months after FMT ]
    Comparison between baseline profile, post FMT and donor profile will show if engraftment of donor microbiota parallels clinical response to active FMT. To assess fecal gut microbiota composition, morning stool samples will be obtained at baseline and three and twelve months after FMT. Participants will collect their first morning bowel movement in a 120ml container for storing in their home freezer (-20C). Two-four weeks after, samples will be collected from participants home and stored on dry ice during transport until freezing at -80°C at the University Hospital of North Norway Harstad. Fecal analysis will be done by NextSeq500 allowing for enhanced metagenomics (prokaryote and viral) sequencing.
  • Difference in metagenomic profile between responders and non responder to FMT [ Time Frame: Baseline samples before FMT ]
    To assess fecal gut microbiota composition, morning stool samples will be obtained at baseline and three and twelve months after FMT. Participants will collect their first morning bowel movement in a 120ml container for storing in their home freezer (-20C). Two-four weeks after, samples will be collected from participants home and stored on dry ice during transport until freezing at -80°C at the University Hospital of North Norway Harstad. Fecal analysis will be done by NextSeq500 allowing for enhanced metagenomics (prokaryote and viral) sequencing.
  • Change in the nature of host immune and antibody response [ Time Frame: Change from baseline to 3 months and difference between responders and non-responders to treatment at 3 months ]
    Analysis (multipex technology) of mediators in the innate and adaptive immune response
  • Change in the nature of host immune and antibody response [ Time Frame: Change from baseline to 12 months and difference between responders and non-responders to treatment at 12 months ]
    Analysis (multipex technology) of mediators in the innate and adaptive immune response
  • Difference in the nature of host immune and antibody response between responders and non responders to FMT [ Time Frame: Baseline samples before FMT ]
    Analysis (multipex technology) of mediators in the innate and adaptive immune response
  • Change in the metabolome in feces, blood and urine [ Time Frame: Change from baseline to 3 months and difference between responders and non-responders to treatment at 3 months ]
    Analysis (mass spectrometry) on fecal extracts, urine and serum in order to assess the functional output of the microbiota
  • Change in biomarkers for breach in gut epithelium (sLPS-binding protein and sCD14) before and after transplantation [ Time Frame: Change from baseline to 3 months and difference between responders and non-responders to treatment at 3 months ]
    Analysis (ELISA) of immunological markers associated with gut barrier leak (sCD14 and sLPS-BP)
  • Change in biomarkers for breach in gut epithelium (sLPS-binding protein and sCD14) before and after transplantation [ Time Frame: Change from baseline to 12 months and difference between responders and non-responders to treatment at 12 months ]
    Analysis (ELISA) of immunological markers associated with gut barrier leak (sCD14 and sLPS-BP)
  • Difference in biomarkers for breach in gut epithelium (sLPS-binding protein and sCD14) in responders and non responders to FMT [ Time Frame: Baseline samples before FMT ]
    Analysis (ELISA) of immunological markers associated with gut barrier leak (sCD14 and sLPS-BP)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Comeback Study
Official Title  ICMJE Fecal Microbiota Transplantation in Chronic Fatigue Syndrome - an RCT
Brief Summary

This is a single-center stratified (on gender and donor), block randomized, placebo-controlled, parallel group trial with 12-months follow-up of 80 chronic fatigue syndrome/encephalomyelitis (CFS/ME) participants. Participants will be randomized to treatment by preprocessed thawed donor fecal microbiota transplant or preprocessed thawed autologous fecal microbiota transplant. Primary endpoint is the efficacy of FMT at three months by the Fatigue Severity Scale. The investigators will use patient reported outcomes for primary and secondary outcome measures.

Previous studies suggest that a dysbiosis of the gut microbiota may be a key feature in CFS/ME. We hypothesize that

A: CFS/ME is caused by a dysbiosis in the gut flora causing barrier leakage of bacterial products, a low grade systemic immune activation and disturbances in the host energy metabolism.

B: Recovery of a normal gut flora by fecal microbiota transplantation (FMT) alleviates symptoms and may even induce remission of CFS/ME.

This project aims to determine if there is a true cause and effect relationship between a dysbiotic gut flora and CFS/ME by testing if treatment of the observed dysbiosis by FMT also can resolve CFS/ME symptoms. In this process, collection of blood, fecal, and urine samples before and after FMT will open the possibility to explore the relationship between the gut flora, immune response, host energy metabolism and CFS/ME using technologies of microbiomics, metabolomics and immunological characterizations for a better understanding of the pathobiology of CFS/ME.

Detailed Description

CFS/ME participants:

General practitioners recruit participants from the local area, by posters at the doctors' offices. In addition the study has a facebook site, named "the COMEBACK study", where interested CFS/ME subjects can submit their interest to be assessed for participation. After a telephone screening of potential participants by the Canada Criteria and CFS/ME severity rating, eligible subjects will be referred to department of physical medicine and rehabilitation UNN Harstad (FYSMED) and re-assessed. During this screening process the investigators will keep a track record of screening failures noting reason for failure. Participants will have a physical exam and necessary workup including blood, fecal and urine tests to exclude differential diagnosis according to the Norwegian National Guidelines for Assessment of CFS/ME. Participants receive information about the study and give their written consent. Subjects earlier diagnosed with CFS/ME at FYSMED will undertake the same re-assessment.

During the work up, participants will do the Fatigue Severity Scale, Hospital Anxiety and Depression scale, SF 36, Modified DePaul Questionnaire, the Rome IV criteria for irritable bowel syndrome, and the "Repeatable Battery for the Assessment of Neuropsychological Status" test (RBANS).

Donors are recruited informally from the local high schools. Donors are included and screened according to the European Consensus Guidelines from 2017. The full screening will be undertaken before the first feces donation and every 4th week. The inclusion and screening will be performed at the department of physical medicine and rehabilitation UNN Harstad. The investigators will keep a track record of screening failures noting reason for failure.

Participants receive FMT at the gastroenterology outpatient clinic at University Hospital of North Norway Harstad, Norway. No antibiotics are given prior to the intervention. The participants must do a bowel lavage using Sodiumpicosulphate/Magnesiumcitrate (Picoprep, Ferring) before intervention. The treatment will be administered by enema. Active treatment will be pre-processed frozen donor feces. Placebo will be the participant's own feces processed and frozen during the study inclusion. After the intervention, the participants have no restrictions on activity level and are asked to keep an unchanged diet without introduction of any new food supplements or probiotics in the follow up period. To keep track of change in diet investigators ask participants to do a food frequency questionnaire before the FMT and at 3 and 12 months after the intervention. Use of antibiotics, food supplement and use of medications will also be recorded.

The treatment will take place in blocks of four consecutive participants per day. A data engineer at the Department of Clinical Research at the University Hospital of North Norway, Tromsø (UNN,Tromsø) creates the allocation sequence using the REDCap software. The treatment is randomized on donor and placebo in fixed blocks of 4 with 2 active (1 donor A and 1 donor B) and 2 placebo. Block allocation will be stratified on gender.

A stratification on donor and gender will be performed by assigning full blocks of male and female participants. In the two active slots in each block of four, one active slot will be used for donor A and one for donor B. The stratification of gender reflects the higher incidence of CFS/ME in women.

Allocation is done in solitude in a closed room with no transparency, only containing a freezer with the active transplants (tagged by donor batch ID) and the placebo transplants (tagged by screening number). Before allocation of treatment, an investigator places the FMT-placebos on a table in the room. A minimum of four participants is allocated to treatment each time. The allocator can then enter the room as the researcher placing all the placebos leaves the room. The allocator will access the randomization sequence when entering participants screening number on the REDCap software using a computer in the same room. The allocator will be the only person involved in the study that can access the randomization program at the REDCap software. If a screening number is randomized to active treatment, the allocator removes the tag from the placebo and places it on a donor FMT treatment instead. All unused placebo transplants will be disposed immediately. When finished, the allocator places the allocated treatment in a box in a designated freezer. The allocator will build a key file matching the active treatment to the donor batch id by updating a key file on paper and store it in a safe not accessible to any others. In addition the allocator will write the corresponding patient screeningnumber on tags from the used donor batch and keep them as backup in the same safe. This will allow for tracking of each individual donor batch to a corresponding participant at the end of trial when all follow up is complete.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Fatigue Syndrome
  • Myalgic Encephalomyelitis
Intervention  ICMJE
  • Biological: Preprocessed thawed donor FMT
    Delivered as an enema using the same equipment and technique as X-ray of the colon
  • Biological: Preprocessed thawed autologous FMT
    Delivered as an enema using the same equipment and technique as X-ray of the colon
Study Arms  ICMJE
  • Experimental: Preprocessed thawed donor FMT

    The active transplants are processed in a 2-3 weeks period before treatment of the first participant. Fifty to eighty grams of freshly delivered feces from donors is mixed with 100 mL isotonic saline and 25 mL 85% glycerol, homogenized and poured through a 0.5 mm mesh steel strainer, and transferred to 60 ml luerlock syringes and stored at -40°C.

    Frozen transplants are slowly thawed 2 hours prior to administration by transferring the FMT-syringes to a waterbath (+30°C). The transplant is then mixed with 125 mL 12°C isotonic saline in an enema bag prior to installation.

    Intervention: Biological: Preprocessed thawed donor FMT
  • Placebo Comparator: Preprocessed thawed autologous FMT

    The placebo transplant from each participant is prepared during the inclusion process four to six weeks before intervention and stored at -40°C. Fifty to eighty grams of freshly delivered feces from participants is mixed with 100 mL isotonic saline and 25 mL 85% glycerol is homogenized and poured through a 0.5 mm mesh steel strainer, and transferred to 60ml Luerlock syringes.

    Frozen transplants are slowly thawed 2 hours prior to administration by transferring the Luerlock syringes to a waterbath (+30°C). The transplant is then mixed with 125 mL 12°C isotonic saline in the enema bag prior to installation.

    Intervention: Biological: Preprocessed thawed autologous FMT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

FMT PARTICIPANTS

Inclusion Criteria:

  • Canada Criteria (2011)
  • 18-65 years
  • Mild-severe CFS/ME
  • Fatigue Severity Scale score of 5,0-7,0
  • Symptom duration for 2-15 years

Exclusion Criteria:

  • Kidney failure
  • Congestive heart failure
  • Immuno-deficiency or use of immune-suppresive drugs
  • Other disease that may explain ME/CFS symptoms discovered during diagnostic work up
  • Use of antibiotics the last three months, low dose naltrexone or Isoprinosin
  • Pregnancy or breastfeeding
  • Serious endogenous depression
  • Chronic infectious disease (HIV, hepatitis B or C etc.)
  • Introduction of new food supplements, change in diet or introduction of new medications the last three months
  • Assessed not be able to follow the instructions for data and sample collection
  • Very severe ME/CFS (WHO class IV)
  • Symptom duration of less than 24 months or more than 15 years

FMT DONORS

Inclusion criteria:

  • Healthy
  • Age 16-30 years
  • Type 3 or 4 stool by the Bristol Stool Scale

Exclusion criteria:

  • Use of peroral antibiotics past 3 months
  • Use of topical antibiotics past 2 months
  • Tattoo or piercing past 6 months
  • Former imprisonment
  • History of: -chronic diarrhea
  • constipation
  • inflammatory bowel disease
  • colorectal polyps
  • colorectal cancer
  • immuno-suppression
  • Obesity
  • Metabolic syndrome
  • Atopic skin disease
  • CFS/ME
  • Psychiatric disorders
  • Other serious autoimmune disease
  • Close relatives with serious autoimmune disease
  • High risk sexual behavior
  • Bowel movements that does not correspond to a Bristol Stool Scale type 3 or 4
  • Journeys abroad the last six months to countries high in antibiotic resistance
  • Use of food supplements, pre-, -pro, -or symbiotics past one month
  • Dysbiosis grade 3 or more by the GA dysbiosis test
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Linn K Skjevling, MD +47 97673939 linn.christin.kallbekken.skjevling@unn.no
Contact: Peter H Johnsen, PhD +47 77015278 peter.holger.johnsen@unn.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03691987
Other Study ID Numbers  ICMJE 2018/180
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Available when findings from primary and secondary endpoints are published. Study protocol will be available upon request when we initiate the inclusion.
Access Criteria: Data access requests will be reviewed by study investigators. Requestors will be required to sign a Data Access Agreement
Responsible Party University Hospital of North Norway
Study Sponsor  ICMJE University Hospital of North Norway
Collaborators  ICMJE
  • The Research Council of Norway
  • Quadram Institute Bioscience
  • Umeå University
  • Cornell University
Investigators  ICMJE
Principal Investigator: Rasmus Goll, MD. PhD. University Hospital of North Norway
PRS Account University Hospital of North Norway
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP