Diet Treatment of Patients With Ulcerative Colitis in Remission
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|ClinicalTrials.gov Identifier: NCT02469220|
Recruitment Status : Active, not recruiting
First Posted : June 11, 2015
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Dietary Supplement: Low FODMAP Dietary Supplement: Standardized FODMAP||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|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|
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
- Gastrointestinal symptoms [ Time Frame: Week 8 ]IBS-SSS questionnaire
- 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
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
|North Denmark Regional Hospital|
|Hjørring, Nordjylland, Denmark, 9800|
|Principal Investigator:||Anne L Krarup, PhD||North Denmark Regional Hospital|
|Principal Investigator:||Jeanette Soerensen, PhD-student||North Denmark Regional Hospital|