Informations générales (source: ClinicalTrials.gov)
Behavior of Various Galenic Forms of a Probiotic in the Digestive Tract (PROBIOSIN)
Interventional
N/A
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
avril 2017
mai 2018
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - Auvergne - France | Patrick LACARIN | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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