NCT03143400

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

May 4, 2017

Last Update Submit

April 30, 2018

Conditions

Healthy VolunteerTerminal Ileostomy

Keywords

ProbioticsGalenic formDigestive tractIntestinal microbiotaLactobacillus salivarius

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Probiotic residual amount in control healthy volunteer

    10 days

  • Probiotic residual amount in ostomy pouch

    8 days

  • Ileal microbiota composition

    8 days

  • Potential occurrence of digestive symptoms or extra-digestive

    8 days

  • Comparison of residual probiotic amount between in vivo and in vitro collection in the stomach, ileon and in stools

    8 days

Study Arms (2)

Healthy volunteers

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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

Interventions

Lactobacillus salivarius BL 3123DRUG

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.

Healthy volunteersIleostomized patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Acute disease, digestive in particular
  • Intake of antibiotics and non-steroidal anti-inflammatory drugs in the last 3 months
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

RECRUITING

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Corinne BOUTELOUP, MD

CONTACT

cbouteloup@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 8, 2017

Study Start

April 6, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

FR(1)