Healthy Volunteer Clinical Trial
Official title:
Behavior of Various Galenic Forms of a Probiotic in the Digestive Tract
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.
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.
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