NCT05845073

The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal Symptoms

A Pilot Clinical Trial Assessing the Effect of Probiotic Supplementation on Antibiotic Associated Gastrointestinal Symptoms and Quality of Life

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: The Archer-Daniels-Midland Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the effect of a multistrain probiotic on gastrointestinal (GI) complaints and diarrhoea in subjects receiving short-term antibiotic (AB) treatment

Detailed description

This study aims to investigate the safety and efficacy of live bacteria on gastrointestinal (GI) complaints and diarrhoea in subjects receiving short-term antibiotic (AB) treatment. The trial will be run in Germany and will recruit adult men and women.

Conditions

• Antibiotic-associated Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Participants in this arm will receive a daily dose of 2x10\^9 Colony Forming Units (CFU) of a multi strain probiotic (live bacterium), corresponding to 2 capsules twice daily, for the duration of antibiotic therapy, and 14 days thereafter.
DIETARY_SUPPLEMENT	Placebo	Participants in this arm will receive an equivalent placebo for for the duration of antibiotic therapy, and 14 day thereafter.

Timeline

• Start date: 2023-05-09
• Primary completion: 2024-07-25
• Completion: 2024-07-25
• First posted: 2023-05-06
• Last updated: 2025-04-09

Locations

1 site across 1 country: Germany