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Treating Chronic Pouchitis With a Low FODMAP Diet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04640155
Recruitment Status : Recruiting
First Posted : November 23, 2020
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
Stephen Hanauer, Northwestern University

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

Condition or disease Intervention/treatment Phase
Pouchitis Behavioral: Low FODMAP Diet Behavioral: Regular Diet Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Chronic Pouchitis With a Low FODMAP Diet
Actual Study Start Date : October 27, 2020
Estimated Primary Completion Date : October 27, 2022
Estimated Study Completion Date : October 27, 2022
Arms and Interventions
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Arm Intervention/treatment
Regular Diet Behavioral: 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.
Experimental: Low FODMAP 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.


Outcome Measures
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Primary Outcome Measures :
  1. Mean Difference in Fecal Calprotectin [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Mean Difference in Composite Symptom Scores [ Time Frame: 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)

  2. Mean Difference in Cleveland Global Quality of Life Score [ Time Frame: 6 weeks ]
  3. Rate of Normalization of Fecal Calprotectin [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04640155


Contacts
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Contact: Adam C Niemann, MD 2172576982 adam.niemannn@northwestern.edu

Locations
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United States, Illinois
Northwestern Medicine Digestive Health Center Recruiting
Chicago, Illinois, United States, 60611
Contact: Adam C Niemann, MD    217-257-6982    adam.niemann@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Stephen B Hanauer, MD Northwestern University Feinberg School of Medicine
More Information
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Responsible Party: Stephen Hanauer, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT04640155    
Other Study ID Numbers: STU00213194
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephen Hanauer, Northwestern University:
Low FODMAP Diet
Pouchitis
Additional relevant MeSH terms:
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Pouchitis
Ileitis
Enteritis
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ileal Diseases