Pouchitis
Conditions
Keywords
Low FODMAP Diet, Pouchitis
Brief summary
We aim to determine whether low FODMAP diet in patients with chronic pouchitis will improve symptoms and pouch inflammation.
Detailed description
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.
Interventions
BEHAVIORALLow FODMAP Diet
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.
BEHAVIORALRegular Diet
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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 18-65 with a diagnosis of ulcerative colitis that have undergone ileal pouch-anal anastomosis following proctocolectomy for medication-refractory disease * Either ≥4 episodes of pouchitis per year (antibiotic-dependent) OR persistent symptoms despite 4 weeks of antibiotic therapy (antibiotic-resistant)
Exclusion criteria
* Diagnosis of indeterminate colitis or Crohn's disease * Celiac disease * Current use of low FODMAP diet * Known dietary allergies * Current use of antibiotics for reasons other than treatment of pouchitis * Clostridium difficile infection * Complication following ileal pouch-anal anastomosis requiring reoperation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Difference in Fecal Calprotectin | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in Composite Symptom Scores | 6 weeks | 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) |
| Mean Difference in Cleveland Global Quality of Life Score | 6 weeks | — |
| Rate of Normalization of Fecal Calprotectin | 6 weeks | — |
Countries
United States
Outcome results
None listed