Use of Novel Prebiotic Fiber for Targeted Dietary Management of Irritable Bowel Syndrome (Nutrabi… (NCT02144753) | Clinical Trial Compass
TerminatedPhase 2
Use of Novel Prebiotic Fiber for Targeted Dietary Management of Irritable Bowel Syndrome (Nutrabiotix Phase II)
Stopped: Per DSMB, study fiber had given subjects more adverse events and made their IBS symptoms worse than the psyllium group.
United States120 participantsStarted 2014-03
Plain-language summary
The objective of this Phase II trial is to test the NTX-1 Fiber in patients with constipation-predominant IBS (IBS-C) and determine if it can reduce symptoms, beneficially modify gut microbiota composition, and improve gut milieu in these patients. The investigators hypothesis for the Phase II study is that NTX-1 Fiber is better tolerated (i.e has less side effects) and is more effective than psyllium (the most commonly used fiber in the US) for symptom improvement and is effective in correcting the abnormal colonic milieu in those with dysbiosis and low SCFA levels.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Between the ages of 18-75
✓. Have recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months
✓. Have at least 2 of the following in the last 6 months:
✓. Improvement of abdominal pain or discomfort with defecation
✓. Onset of abdominal pain or discomfort associated with change in frequency of stool
✓. Onset of abdominal pain or discomfort associated with a change in form/appearance of stool
✓. Symptom onset at least 6 months prior to screening date
✓. Willing to take study supplement three times a day and willing to comply with all study procedures (i.e. swallow capsules)
Exclusion criteria
✕. Abnormalities in CBC (Hgb\<12 g/dL, platelet count\<100000, WBC\<4000 or \>10000)
✕
What they're measuring
1
Composite improvement in the following three areas: IBS global improvement score on the Likert Scale, frequency & consistency of stools, & severity of abdominal pain, discomfort and bloating