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This study has been stopped due to difficulty with enrollment.
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We aim to determine whether low FODMAP diet in patients with chronic pouchitis will improve symptoms and pouch inflammation.
Following recruitment for entry into the study, subjects be asked to complete symptom surveys and provide a fecal sample for calprotectin measurement. Shortly after their screening visit, patients will be randomized 1:1 to either the low FODMAP diet (experimental) or regular diet (control) group. Patients in the experimental group will schedule a telephone visit with a registered dietician. During this approximately hour-long session, patients in the low FODMAP cohort will be counseled regarding FODMAP containing foods. They will be asked to adhere to this diet over the next 6 weeks. At the end of the 6 week period, subjects will complete a 3-day food diary. Those in the regular diet group will be contacted by the dietician and given an educational handout at the beginning of the study period regarding best dietary practices. At the end of the 6 week study period, both groups will again be asked to complete another set of symptom surveys and provide a fecal sample for calprotectin measurement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular Diet | Other |
| |
| Low FODMAP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low FODMAP Diet | Behavioral | Patients in the low FODMAP group will schedule a telephone visit with a registered dietician. During this approximately hour-long session, patients in the low FODMAP cohort will be counselled regarding FODMAP containing foods and how to effectively remove them while maintaining a nutrition-rich diet. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in Fecal Calprotectin | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in Composite Symptom Scores | Composite symptom score will include both clinical portion of Pouchitis Disease Activity Index as well as Oresland score, with possible scores ranging from 0-21 (higher number indicates higher symptom burden) | 6 weeks |
| Mean Difference in Cleveland Global Quality of Life Score |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Stephen B Hanauer, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medicine Digestive Health Center | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D019449 | Pouchitis |
| ID | Term |
|---|---|
| D007079 | Ileitis |
| D004751 | Enteritis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000092622 | FODMAP Diet |
| D004032 | Diet |
| ID | Term |
|---|---|
| D000092724 | Elimination Diets |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| Regular Diet | Behavioral | Patients in the regular diet group will receive an educational handout discussing low fiber diet, which is standard of care for those with pouchitis symptoms. |
|
| 6 weeks |
| Rate of Normalization of Fecal Calprotectin | 6 weeks |
| D004066 |
| Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D007077 | Ileal Diseases |