At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 366 enrolled
Drug / intervention
Blautix +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicenter 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
In Brief
A Phase 2 clinical trial evaluating Blautix and Placebo for Irritable Bowel Syndrome. Completed, enrolled 366 participants across 34 sites in 3 countries.
Detailed Summary
A study to evaluate the effectiveness of oral doses of Blautix in adult participants with irritable bowel syndrome (IBS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesIreland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartOct 2018
First PostedOct 2018
Primary CompletionMay 2020
TodayJul 2026
First PostedOct 26, 2018
Enrollment StartOct 11, 2018
Primary CompletionMay 13, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.7 years ago
Interventions
Blautixbiological
Blautix is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The study dosing regimen was two capsules two times per day for the duration of the treatment period.
Placeboother
Placebo control