Treating Chronic Pouchitis With a Low FODMAP Diet

Pouchitis Clinical Trial

Official title:

Treating Chronic Pouchitis With a Low FODMAP Diet

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04640155
• Other study ID #: STU00213194
• Status: Withdrawn
• Phase: N/A
• Start date: October 27, 2020
• Est. completion date: October 27, 2022

Study information

• Verified date: February 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We aim to determine whether low FODMAP diet in patients with chronic pouchitis will improve symptoms and pouch inflammation.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 27, 2022
• Est. primary completion date: October 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pouchitis

Intervention

Behavioral:
• Low 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.
• Regular 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.

Locations

Country	Name	City	State
United States	Northwestern Medicine Digestive Health Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Difference in Fecal Calprotectin		6 weeks
Secondary	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
Secondary	Mean Difference in Cleveland Global Quality of Life Score		6 weeks
Secondary	Rate of Normalization of Fecal Calprotectin		6 weeks