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

NCT03721107 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2022-01-11

Study results available
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Summary

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

Conditions

  • Irritable Bowel Syndrome

Interventions

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

Sponsors & Collaborators

  • 4D pharma plc

    lead INDUSTRY

Principal Investigators

  • Eamonn Quigley · Houston Methodist Gastroenterology Clinical Research Foundation, Houston, Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-11
Primary Completion
2020-05-13
Completion
2020-05-13
FDA Drug
Yes

Countries

  • United States
  • Ireland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03721107 on ClinicalTrials.gov