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

Depression, Anxiety Clinical Trial

Official title: 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

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

• NCT number: NCT04422327
• Study type: Interventional
• Source: PrecisionBiotics Ltd.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 20, 2017
• Completion date: February 12, 2018