Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low FODMAP diet | Experimental | 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. |
|
| Standardized FODMAP | Active Comparator | 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. |
|
| Control | No Intervention | Watchful waiting. No diets or food supplements are administered |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low FODMAP | Dietary Supplement | Blinded food supplements containing only items with a low content of FODMAPs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms | IBS-SSS questionnaire | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of life | SF-36 questionnaire | Week 8 |
| Pain diary | VAS scales on a daily basis | Daily during the study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anne L Krarup, PhD | Regionshospital Nordjylland | Principal Investigator |
| Jeanette Soerensen, PhD-student | Regionshospital Nordjylland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Denmark Regional Hospital | Hjørring | North Denmark | 9800 | Denmark |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000092622 | FODMAP Diet |
| ID | Term |
|---|---|
| D000092724 | Elimination Diets |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standardized FODMAP | Dietary Supplement | Blinded food supplements containing FODMAPs |
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010829 | Physiological Phenomena |