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Biomarker-based Multidisciplinary Team (Bio-MDT) Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease (Bio-MDT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082559
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : September 13, 2019
Sponsor:
Collaborators:
The Leona M. and Harry B. Helmsley Charitable Trust
Tel Aviv University
Information provided by (Responsible Party):
IRIS DOTAN, Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE August 28, 2019
First Posted Date  ICMJE September 9, 2019
Last Update Posted Date September 13, 2019
Actual Study Start Date  ICMJE June 11, 2019
Estimated Primary Completion Date June 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • Time interval to response [ Time Frame: One year ]
    Decrease in PGA and PDAI
  • Time interval to remission [ Time Frame: One year ]
    PGA=0 and PDAI<7
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biomarker-based Multidisciplinary Team (Bio-MDT) Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease
Official Title  ICMJE Biomarker-based Multidisciplinary Team Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease
Brief Summary

Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) currently affecting over 5 million patients globally, mostly young adults. These conditions are often debilitating, disabling and may markedly affect patient's quality of life. Despite important advances in research, the pathogenesis of IBD remains obscure, the incidence-rising, the condition - incurable, and drugs have a modest effect. The common denominator may be environmental factors, specifically diet and the microbiome, which remain a fundamental unmet need in IBD care as high quality randomized trials and mechanistic research are limited. Up to a quarter of patients with UC may undergo complete large bowel resection due to disease complications. In order to preserve bowel continuity, this surgery includes a restorative part with creation of a reservoir ("pouch") from normal small bowel instead of the resected rectum. The majority of these patients develop small intestinal inflammation in the previously normal small bowel creating the pouch ("pouchitis").

Based on our results from previous studies, we hypothesized that personalized antibiotics and dietary interventions will modify microbial composition and result in significantly improved outcomes, specifically resolution of inflammation and prolonged remission rates in patients with a pouch.

Aims:

  1. Compare the effect of two antibiotic treatments on clinical, inflammatory and microbiological outcomes of patients with pouch inflammation.
  2. Evaluate the effect of combined microbiome-targeted antibiotic and dietary intervention as treatment and prevention strategy in patients after pouch surgery.
  3. Evaluate the effect of a microbiome-targeted dietary intervention as prevention strategy in patients after pouch surgery.
  4. Identify predictors for response to specific antibiotic and dietary interventions.
Detailed Description

All patients will undergo comprehensive screening by the bio-MDT.

Aim 1: Antibiotic treatment- (patients with active disease) will be randomized to receive a prescription for one of two antibiotic regimens.

  1. Ciprofloxacin + metronidazole
  2. Doxycycline+ metronidazole

Aim 2: Combination therapy ( Antibiotics+diet) After arm 1 recruitment completion, a favorable antibiotic regimen will be determined and recommended in arm 2, in which, patients with active disease will be randomized to

  1. Favorable antibiotics + Mediterranean diet (MED)
  2. Favorable antibiotics + The Specific Carbohydrate Diet (SCD)

Aim 3: Nutritional prevention-

Patients in clinical remission will be recruited to a dietary prevention study and be allocated to one of three groups:

  1. Mediterranean diet (MED)
  2. Control- based on the American Dietetic Association recommendations for patients with IBD.
  3. Personalized nutrition group- based on prior results from study- NCT02858557

Comprehensive assessment including nutritional, clinical, inflammatory and microbial parameters will be performed at baseline and at weeks 2,3,4,8,26, 52.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Inflammatory Bowel Diseases
Intervention  ICMJE
  • Other: Arm 1- Antibiotics treatment
    Patients with active disease will be randomized and will receive a prescription antibiotic regimens
    Other Name: Ciprofloxacin 500 mg 2/d + metronidazole 500 mg 2/d for two weeks
  • Other: Arm 2- Antibiotics treatment
    Patients with active disease will be randomized and will receive a prescription antibiotic regimens
    Other Name: Doxycycline 100 mg 2/d + metronidazole 500 mg 2/d for two weeks
  • Other: Arm 1- Combination therapy (Antibiotics + diet)
    Patients with active disease receiving a prescription for the antibiotic regimen defined as favorable in the antibiotics according to aim 1 , and randomized into one of two dietary interventions: Mediterranean diet (MED) or the specific carbohydrate diet (SCD).
    Other Name: Favorable antibiotics (according to aim 1) for two weeks + Mediterranean diet (MED) for 8 weeks.
  • Other: Arm 2- Combination therapy (Antibiotics + diet)
    Patients with active disease receiving a prescription for the antibiotic regimen defined as favorable in the antibiotics according to aim 1 , and randomized into one of two dietary interventions: Mediterranean diet (MED) or the specific carbohydrate diet (SCD).
    Other Name: Favorable antibiotics (according to aim 1) for two weeks + specific carbohydrate diet (SCD) for 8 weeks.
  • Other: Arm 1- Nutritional prevention
    Patients in clinical remission will be recruited to a dietary prevention study
    Other Name: Mediterranean diet
  • Other: Arm 2- Nutritional prevention
    Patients in clinical remission will be recruited to a dietary prevention study
    Other Name: Control- based on the American Dietetic Association recommendations for patients with IBD
  • Other: Arm 3- Nutritional prevention
    Patients in clinical remission will be recruited to a dietary prevention study
    Other Name: Personalized nutrition group- based on prior results from study- NCT02858557
Study Arms  ICMJE
  • Antibiotic treatment

    Patients with active disease will be randomized and will receive a prescription for one of two antibiotic regimens.

    1. Ciprofloxacin 500 mg 2/d + metronidazole 500 mg 2/d for two weeks
    2. Doxycycline 100 mg 2/d + metronidazole 500 mg 2/d for two weeks
    Interventions:
    • Other: Arm 1- Antibiotics treatment
    • Other: Arm 2- Antibiotics treatment
  • Combination therapy (Antibiotics + diet)
    1. Favorable antibiotics (according to aim 1) for two weeks + Mediterranean diet (MED) for 8 weeks.
    2. Favorable antibiotics (according to aim 1) for two weeks + specific carbohydrate diet (SCD) for 8 weeks.
    Interventions:
    • Other: Arm 1- Combination therapy (Antibiotics + diet)
    • Other: Arm 2- Combination therapy (Antibiotics + diet)
  • Nutritional prevention

    Patients in clinical remission will be recruited to a dietary prevention study.

    1. Mediterranean diet
    2. Control- based on the American Dietetic Association recommendations for patients with IBD
    3. Personalized nutrition group- based on prior results from study- NCT02858557
    Interventions:
    • Other: Arm 1- Nutritional prevention
    • Other: Arm 2- Nutritional prevention
    • Other: Arm 3- Nutritional prevention
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 5, 2019)
170
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 11, 2023
Estimated Primary Completion Date June 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients are able and willing to sign an informed consent
  2. Patients with UC who underwent pouch surgery and have a functioning pouch
  3. Disease activity (PDAI and PGA) according to study arm 1-3 inclusion

Exclusion Criteria:

  1. Patients with ileostomy
  2. Significant comorbidity that precludes the patient from participating according to the physicians' judgment
  3. Non-Hebrew readers
  4. Pregnant and lactating women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Iris Dotan, Prof +97237525015 irisdo@clalit.org.il
Contact: Lihi Godny, BSc +97237525015 lihigodny@gmail.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04082559
Other Study ID Numbers  ICMJE 0129-19-RMC
Has Data Monitoring Committee No
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: Undecided
Responsible Party IRIS DOTAN, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE
  • The Leona M. and Harry B. Helmsley Charitable Trust
  • Tel Aviv University
Investigators  ICMJE Not Provided
PRS Account Rabin Medical Center
Verification Date August 2019

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