NCT04422327

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

An Open Label Study to Assess the Impact of 'COMBO' on Mood, Stress and Bowel Symptoms in Adults With Irritable Bowel Syndrome (IBS)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: PrecisionBiotics Group Ltd. · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is an open label study designed to assess the impact on stress, mood and bowel symptoms \& safety of COMBO, a combination of Bifidobacterium longum 35624® and Bifidobacterium longum 1714™ strains, when consumed once daily for 8 weeks, in adults with Irritable Bowel Syndrome (IBS). Volunteers will be screened according to the selection criteria in order to identify up to 40 female subjects, with recurrent abdominal pain/discomfort and mild to moderate stress/mood status. The study will involve 6 visits over an 18 to 20-week period \[Screening period (Visit 1: week-2), Intervention period (Visit 2: week 0, Visit 3: week 4, Visit 4: week 8), and Follow-up/ Washout period (Visit 5: week 12, Visit 6: week 16)\]. Participants will fill in daily and weekly eDiary from 1st visit onwards. Questionnaires will be administered from visit 2 to visit 6. Research blood and saliva will also be collected at these time points. Stool sample will be collected at Visit 2, 4, 5, 6.

Conditions

• IBS - Irritable Bowel Syndrome
• Depression, Anxiety

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic capsule	Each probiotic capsule contains 5 x 10\^8 CFU B. longum 35624® and 5 x 10\^8 CFU B. longum 1714™ with corn starch and magnesium stearate. The probiotic capsule will be supplied by PrecisionBiotics Ltd.

Timeline

• Start date: 2017-09-20
• Primary completion: 2018-02-12
• Completion: 2018-02-12
• First posted: 2020-06-09
• Last updated: 2020-06-09

Locations

1 site across 1 country: Ireland