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

Healthy Volunteer Clinical Trial

— PROBIOSIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03143400
• Other study ID #: CHU-322
• Secondary ID: 2016-A00597-44
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2017
• Est. completion date: May 2018

Study information

• Verified date: April 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

For the healthy volunteer group :

• age between 18 and 65 years old

• without previous digestive pathology that could have modified probiotic survival either by the disease itself or by its treatments (IBD, cholestatic disease, pancreatic insufficiency)

• without previous digestive surgery (except from appendectomy)

• ability to sign written informed consent

• health insurance

For the patients with a ostomy pouch :

• Age between 18 and 65 years old

• Terminal or preterminal (less than 30 cm of resected ileon) ileostomy performed more than 2 months ago with a stabilized digestive situation and a healthy residual intestine.

• Without other digestive resection (gall bladder, stomach, pancreas)

• Healthy and diversified diet

• Health insurance

Exclusion Criteria for both groups :

• Acute disease, digestive in particular

• Intake of antibiotics and non-steroidal anti-inflammatory drugs in the last 3 months

• Intake of probiotics and symbiotic within the month before inclusion, either in a food supplement form (Lactibiane, Probiolog, Bacilor, Ergyphyllus, Bion3,) or as a milk product (Actimel, Activia, LC1)

• Intake of an antacid or gastric antisecretory (anti-H2, proton pump inhibitor) the week before study

• Intake of gastric emptying modificators and drugs that could slow down bowel movement (domperidone, metoclopramide, morphinise, loperamide) within 48 hours before study.

• Pregnant or breastfeeding women

• Patient under guardianship or curatorship

Related Conditions & MeSH terms

• Healthy Volunteer
• Terminal Ileostomy

Intervention

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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	3iNATURE, FEDER, Université d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate of Lactobacillus salivarius	Measured by qPCR and determination of CFU in gastric content and in stools for each galenic form.	7 days
Secondary	Probiotic residual amount in control healthy volunteer	Measured by qPCR and determination of CFU	10 days
Secondary	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.	8 days
Secondary	Ileal microbiota composition	Patients with ostomy pouch	8 days
Secondary	Potential occurrence of digestive symptoms or extra-digestive	Nausea, bloating, flatulence, abdominal pain, intestinal transit modification	8 days
Secondary	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	8 days