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Diet Treatment of Patients With Ulcerative Colitis in Remission

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469220
Recruitment Status : Active, not recruiting
First Posted : June 11, 2015
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Anne Lund Krarup, Vendsyssel Hospital

Tracking Information
First Submitted Date  ICMJE June 8, 2015
First Posted Date  ICMJE June 11, 2015
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE July 1, 2018
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
Gastrointestinal symptoms [ Time Frame: Week 8 ]
IBS-SSS questionnaire
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
Gastrointestinal symptoms [ Time Frame: Week 0, 3 and 6 ]
IBS-SSS questionnaire
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Change in Quality of life [ Time Frame: Week 8 ]
    SF-36 questionnaire
  • Pain diary [ Time Frame: Daily during the study ]
    VAS scales on a daily basis
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
  • Quality of life [ Time Frame: Week 0 and 6 ]
    SF-36 questionnaire
  • Gut microbiota composition and activity [ Time Frame: Week 0 and 6 ]
    Fecal and urine samples
  • Inflammatory markers [ Time Frame: Week 0 and 6 ]
    Blood and fecal samples
  • Markers for anemia [ Time Frame: Week 0 and 6 ]
    Blood samples
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diet Treatment of Patients With Ulcerative Colitis in Remission
Official Title  ICMJE Diet Treatment of Patients With Ulcerative Colitis in Remission
Brief Summary The study examines the effect of a low FODMAP diet in patients with UC in remission but still having GI symptoms (IBS in IBD). 15 patients will be on watchful waiting. 15 patients will be on low FODMAP diet. 15 patients with recieve FODMAPs in their diet.
Detailed Description

Patients are randomized to either standard care, low FODMAP diet or a normal FODMAP diet. Run-in on a low FODMAP diet, thereafter parallel design where one arm is assign a blinded food supplement with low FODMAP content and the other arm is assigned a blinded food supplement containing FODMAP. A control group is "watchful waiting".

Symptom reports, blood, and fecal samples are collected.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • Dietary Supplement: Low FODMAP
    Blinded food supplements containing only items with a low content of FODMAPs
  • Dietary Supplement: Standardized FODMAP
    Blinded food supplements containing FODMAPs
Study Arms  ICMJE
  • Experimental: Low FODMAP diet
    Diet with a low content of fermentable oligo-, di-, monosaccharides and polyols (low FODMAP diet). The patients will receive dietary instructions from registered clinical dieticians. A food supplement low in FODMAPS are administered in a blinded fashion.
    Intervention: Dietary Supplement: Low FODMAP
  • Active Comparator: Standardized FODMAP
    Diet with a low content of fermentable oligo-, di-, monosaccharides and polyols (low FODMAP diet). The patients will receive dietary instructions from registered clinical dieticians. A food supplement with FODMAPS are administered in a blinded fashion.
    Intervention: Dietary Supplement: Standardized FODMAP
  • No Intervention: Control
    Watchful waiting. No diets or food supplements are administered
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 25, 2020)
19
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2015)
30
Estimated Study Completion Date  ICMJE July 31, 2021
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Colitis ulcerosa in remission (calciprotectin<200 and normal sigmoidoscopy)
  • ROM IV criteria fullfilled
  • Stable medical therapy

Exclusion Criteria:

  • Intake of a low FODMAP diet within the past 6 weeks prior to baseline
  • Atypical colitis ulcerosa primarily right sided disease and calciprotectin >50 unless normal sigmoidoscopy
  • If diarrhea: Clostridium difficile infection
  • Lactose intolerance
  • Systemisk or local treatment for CU other than 5-aminosalicylicacid or biological therapy
  • Antibiotics within 6 weeks
  • Pregnancy
  • Activity in UC
  • Coeliac disease
  • Abnormal transglutaminase
  • Eating disorder
  • Special diet preventing the low FODMAP diet
  • Other GI disease or other disease explaining symptoms
  • Medication intake explaining symptoms
  • Not able to follow protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02469220
Other Study ID Numbers  ICMJE RHN_ALK_01
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 Not Provided
Responsible Party Anne Lund Krarup, Vendsyssel Hospital
Study Sponsor  ICMJE Vendsyssel Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne L Krarup, PhD North Denmark Regional Hospital
Principal Investigator: Jeanette Soerensen, PhD-student North Denmark Regional Hospital
PRS Account Vendsyssel Hospital
Verification Date October 2020

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