NCT03721107

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: 4D pharma plc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the effectiveness of oral doses of Blautix in adult participants with irritable bowel syndrome (IBS).

Detailed description

Participants with a diagnosis of IBS will be enrolled as defined by Rome IV criteria and will be classified into cohorts according to the Rome IV classification of IBS subtypes. Each cohort (Cohort C and Cohort D) will recruit participants who will randomly receive either Blautix or matching placebo in a 1:1 ratio overall of treated to control participants. Participants will undergo five visits in total across approximately 13 weeks. During the study treatment phase, participants will be asked to complete a variety of Quality of Life questionnaires at certain time points. These will consist of abdominal pain intensity score, IBS symptom severity (IBS-SSS), IBS quality of life (IBS-QoL), hospital anxiety and depression score (HADS), stool frequency, stool consistency \& food frequency questionnaire. Participants will be required to produce relevant blood, urine and faecal samples at pre-determined timepoints from screening through to End of Treatment and follow up visits.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Blautix	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.
OTHER	Placebo	Placebo control

Timeline

• Start date: 2018-10-11
• Primary completion: 2020-05-13
• Completion: 2020-05-13
• First posted: 2018-10-26
• Last updated: 2022-01-11
• Results posted: 2022-01-11

Locations

34 sites across 3 countries: United States, Ireland, United Kingdom

Regulatory

• FDA-regulated drug study