A Trial for New Treatment of Adult Patients With Irritable Bowel Syndrome

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A Trial for New Treatment of Adult Patients With Irritable Bowel Syndrome

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A Phase II Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicentre Study to Evaluate the Safety and Efficacy of Repeated Oral Doses of Blautix in Adult Subjects With Irritable Bowel Syndrome (IBS) Subtypes IBS-C and IBS-D

clinicaltrials.gov

Eligibility

Inclusion Criteria

– Males and Females between 18 and 70 years of age
– Body Mass Index (BMI): 18-39 kg/m2
– Having IBS-C or IBS-D as defined by Rome IV* including Subtype Classification
– Have a moderate or severe IBS symptom severity score (>175) as defined by IBS-SSS * Recurrent abdominal
pain on average, at least 1 day/week in the last 3 months associated with two or more of the following
criteria:
– Related to defecation
– Associated with a change in frequency of stool
– Associated with a change in form (appearance) of stool

Exclusion Criteria

– Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrine,
immunological, metabolic or any condition which contraindicates, in the investigators’ judgment, entry
to the study)
– Confirmed clinical diagnosis of bile acid malabsorption and/or on medication for bile acid
malabsorption
– Have a malignant disease or any concomitant end-stage organ disease.
– Use of antibiotics within 1 month of screening
– Use of systemic steroids within the last month
– Clinically diagnosed Lactose intolerance
– Clinically diagnosed Coeliac disease
– Change of diet e.g. FODMAP, gluten-free within last 3 months
– Any abdominal surgery other than hernia repair or appendectomy
– Subjects who have taken commercially available probiotics within the last month
– Subjects with known or suspected hereditary fructose intolerance, glucose-galactose malabsorption or
sucrase-isomaltose insufficiency

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