An interventional study of Lactobacillus salivarius BL 3123 in Healthy Volunteer and Terminal Ileostomy, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-01.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Other
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.
University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For the healthy volunteer group :
For the patients with a ostomy pouch :
Exclusion Criteria for both groups :
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.
Drug: Lactobacillus salivarius BL 3123
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.
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.
Survival rate of Lactobacillus salivarius
Measured by qPCR and determination of CFU in gastric content and in stools for each galenic form.
Time frame: 7 days
Probiotic residual amount in control healthy volunteer
Measured by qPCR and determination of CFU
Time frame: 10 days
Probiotic residual amount in ostomy pouch
Measured by qPCR and determination of CFU. Fecal microbiota composition at D0 and D8 after the first intake, in the healthy volunteer group, for each 3 galenic forms.
Time frame: 8 days
Ileal microbiota composition
Patients with ostomy pouch
Time frame: 8 days
Potential occurrence of digestive symptoms or extra-digestive
Nausea, bloating, flatulence, abdominal pain, intestinal transit modification
Time frame: 8 days
Comparison of residual probiotic amount between in vivo and in vitro collection in the stomach, ileon and in stools
Measured by qPRC and determination of CFU number
Time frame: 8 days
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand