Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Dietary Supplement: Low FODMAP Dietary Supplement: Standardized FODMAP Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Diet Treatment of Patients With Ulcerative Colitis in Remission
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : August 31, 2020
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Dietary Supplement: Low FODMAP
Blinded food supplements containing only items with a low content of FODMAPs

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.
Dietary Supplement: Standardized FODMAP
Blinded food supplements containing FODMAPs

No Intervention: Control
Watchful waiting. No diets or food supplements are administered



Primary Outcome Measures :
  1. Gastrointestinal symptoms [ Time Frame: Week 8 ]
    IBS-SSS questionnaire


Secondary Outcome Measures :
  1. Change in Quality of life [ Time Frame: Week 8 ]
    SF-36 questionnaire

  2. Pain diary [ Time Frame: Daily during the study ]
    VAS scales on a daily basis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469220


Locations
Layout table for location information
Denmark
North Denmark Regional Hospital
Hjørring, Nordjylland, Denmark, 9800
Sponsors and Collaborators
Vendsyssel Hospital
Investigators
Layout table for investigator information
Principal Investigator: Anne L Krarup, PhD North Denmark Regional Hospital
Principal Investigator: Jeanette Soerensen, PhD-student North Denmark Regional Hospital
Layout table for additonal information
Responsible Party: Anne Lund Krarup, MD, PhD, Vendsyssel Hospital
ClinicalTrials.gov Identifier: NCT02469220    
Other Study ID Numbers: RHN_ALK_01
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anne Lund Krarup, Vendsyssel Hospital:
Diet
low FODMAP
UC
IBS
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases