An interventional study of Low FODMAP Diet and Regular Diet in Pouchitis, sponsored by Northwestern University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-13.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
50 studies on the registry are indexed under Pouchitis; 12 are open to participants now.
Browse Pouchitis studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Regular Diet
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.
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.
Mean Difference in Fecal Calprotectin
Time frame: 6 weeks
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)
Time frame: 6 weeks
Mean Difference in Cleveland Global Quality of Life Score
Time frame: 6 weeks
Rate of Normalization of Fecal Calprotectin
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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