NCT04422327: IBS

The Impact of a Combination of Bifidobacterium Longum 35624® and 1714™ Strains in Adults With Irritable Bowel Syndrome

Completed Phase 1, PHASE2 Last updated 9 June 2020

What this trial tests

Phase 1, PHASE2 trial testing Probiotic capsule in IBS - Irritable Bowel Syndrome in 40 participants. Completed in 12 February 2018.

Timeline

20 September 2017

Primary endpoint
12 February 2018

12 February 2018

Quick facts

Lead sponsor	PrecisionBiotics Group Ltd.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	20 September 2017
Primary completion	12 February 2018
Estimated completion	12 February 2018
Sites	1 location across Ireland

Drugs / interventions tested

• Probiotic capsule

Conditions studied

• IBS - Irritable Bowel Syndrome — all drugs for IBS - Irritable Bowel Syndrome →
• Depression, Anxiety — all drugs for Depression, Anxiety →

Sponsor

PrecisionBiotics Group Ltd.

Who can join

Adults 18 to 55, female only, with IBS - Irritable Bowel Syndrome or Depression, Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aimed to assess the impact of consumption of COMBO, a combination product of two Bifidobacterium longum strains, on stress, mood and bowel symptoms in adults with Irritable Bowel Syndrome (IBS).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mechanistic Insights into the Link between Gut Dysbiosis and Major Depression: An Extensive Review.
   Sonali S, Ray B, Ahmed Tousif H, Rathipriya AG, et al · · 2022 · cited 80× · PMID 35456041 · DOI 10.3390/cells11081362