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A randomized, double-blind, placebo-controlled pilot study in patients with IBS-D according to Rome IV criteria evaluating the clinical efficacy and safety of oral administration of 2g G-PUR® tid compared to placebo in a cohort of 30 patients over an active treatment period of 12 weeks.
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Inclusion criteria
Age 18-75 years
Recurrent abdominal pain, at least one day/week in the last 3 months (with symptom onset at least 6 months before diagnosis), associated with two or more of the following criteria (Rome IV criteria)
Moderate to severe abdominal pain as defined with an IBS Symptoms Severity Scale (IBS-SSS) score > 175
Patient reports that abnormal bowel movements are usually diarrhea with more than one-fourth (25%) of bowel movements with Bristol stool form types 6 or 7 and less than one-fourth (25%) of bowel movements with Bristol stool form types 1 or 2. Starting during the screening/run-in phase, all patients will keep diaries of stool frequency and consistency. Stool consistency will be assessed according to the Bristol Stool Form scale (Lewis and Heaton, 1997)
Stable eating habits, within one month before randomization
In patients > 50 years colonoscopy performed during the past 5 years demonstrates no pathology associated with the symptoms reported for IBS
Ability to understand trial instructions and to comply with treatment
Patient agree to be compliant for study interactive web - response system schedule confirmed at time of randomization
Written informed consent prior to enrolment
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups, including a placebo group
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Central trial contact
Michael Wolzt, Prof. Dr.
Data sourced from clinicaltrials.gov
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