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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteer; Terminal Ileostomy
• Intervention / Treatment: Drug: Lactobacillus salivarius BL 3123

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.

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corinne BOUTELOUP, MD; Email: cbouteloup@chu-clermontferrand.fr

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • Recruiting
      • CHU Clermont-Ferrand
      • Contact: Corinne BOUTELOUP, MD; Email: cbouteloup@chu-clermontferrand.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy volunteers; 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; 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.
Active Comparator: Ileostomized patients; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probiotic residual amount in control healthy volunteer	Measured by qPCR and determination of CFU	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.	8 days
Ileal microbiota composition	Patients with ostomy pouch	8 days
Potential occurrence of digestive symptoms or extra-digestive	Nausea, bloating, flatulence, abdominal pain, intestinal transit modification	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	8 days

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Université d'Auvergne; European Regional Development Fund; 3i nature

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Probiotics; Intestinal microbiota; Digestive tract; Lactobacillus salivarius; Galenic form
• Other Study ID Numbers: CHU-322; 2016-A00597-44 (Other Identifier: 2016-A00597-44)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No