NCT03143400

Behavior of Various Galenic Forms of a Probiotic in the Digestive Tract.

Behavior of Various Galenic Forms of a Probiotic in the Digestive Tract

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess the behavior of a model probiotic strain, Lactobacillus salivarius, in the digestive tract of healthy volunteers and of ileostomized patients, depending on its galenic form. Two classic forms will be tested (powder and pill). An innovative galenic form (pill with retarded release), developed to enhance intestinal viability and probiotic efficacy, will also be tested.

Detailed description

Probiotic survival in the stomach and in stools will be assessed on 9 healthy volunteers. It will be evaluated in the stomach after one unique probiotic intake. Gastric content will be collected at different times, up until an hour after probiotic ingestion. Fecal probiotic survival will be evaluated after a 7-day period of probiotic intake. Initial stool collection, before first probiotic intake, will be used as control. Stools will be collected after 7 days of treatment (D8) and 3 days after last intake (D10). Probiotic survival in the small intestine will be assessed on 9 patients with stable medical condition that either have a terminal or preterminal ileostomy. It will be evaluated after one unique probiotic intake. Ileal content will then be collected within 4 hours after intake. Probiotic survival will be evaluated in the stomach, small intestine and in stools by qPCR and determination of CFU. Microbiota composition will be determined by pyrosequencing on ileal and fecal samplings. Finally, metabolic activity will be determined by chromatography with a short chain fatty acid dosage. Healthy volunteers will test each of the 3 galenic forms of Lactobacillus salivarius on 3 periods of 7 days. Each period will be separated from another with a 14-day wash-out period at least. Ileostomized patients will only take a unique dose of each probiotic. Each intake of a different probiotic will be separated from another by a 14-day wash-out period at least.

Conditions

• Healthy Volunteer
• Terminal Ileostomy

Interventions

Type	Name	Description
DRUG	Lactobacillus salivarius BL 3123	Two classic forms will be tested (powder and pill). An innovative galenic form (pill with retarded release), developed to enhance intestinal viability and probiotic efficacy, will also be tested.

Timeline

• Start date: 2017-04-06
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2017-05-08
• Last updated: 2018-05-01

Locations

1 site across 1 country: France