drugset / Trial / NCT03721107

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

NCT03721107 ↗

Phase 2 Completed 366 enrolled 4D pharma plc
RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start
2018-10-11
Primary completion
2020-05-13
Completion
2020-05-13

Outcome

Missed primary endpoint

registry Cohort C: Blautix vs Cohort C: Placebo; p = 0.152; Difference in Percentage 7.9 (95% CI -6.0 to 21.9) NCT03721107 ↗

registry Cohort D: Blautix vs Cohort D: Placebo; p = 0.216; Difference in Percentage 5.6 (95% CI -6.8 to 18.0) NCT03721107 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Blautix Unknown — —