NCT02592200

Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women

A Double Blind Placebo-Controlled Study on the Effect of the Probiotic Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women - Proof of Concept

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: BioGaia AB · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to determine the change in frequency of complete spontaneous bowel movements (CSBMs) after 4 weeks of oral supplementation with Lactobacillus gasseri DSM 27123 in healthy adult women with functional constipation.

Detailed description

Subjects to complete study diaries, number of SBM, CSBM, form of faeces (according to the Bristol Stool Form scale), pain during defecation (according to the visual analogue scale \[VAS\] 0-100), time spent at each evacuation, episodes of faecal incontinence, number of ingested capsules of investigational product will be recorded daily by the subjects

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus gasseri DSM 27123	109 CFU (divided in two doses) per day for 28 days
DIETARY_SUPPLEMENT	Placebo	Two doses per day for 28 days

Timeline

• Start date: 2015-10-05
• Primary completion: 2016-06-21
• Completion: 2016-07-31
• First posted: 2015-10-30
• Last updated: 2021-01-05

Locations

1 site across 1 country: Sweden