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Treating Chronic Pouchitis With a Low FODMAP Diet

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Northwestern University

Status

Withdrawn

Conditions

Pouchitis

Treatments

Behavioral: Regular Diet
Behavioral: Low FODMAP Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT04640155
STU00213194

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

Regular Diet
Other group
Treatment:
Behavioral: Regular Diet
Low FODMAP
Experimental group
Treatment:
Behavioral: Low FODMAP Diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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