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Trial record 31 of 6722 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

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

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ClinicalTrials.gov Identifier: NCT03143400
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : May 1, 2018
Sponsor:
Collaborators:
3i nature
European Regional Development Fund
Université d'Auvergne
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteer Terminal Ileostomy Drug: Lactobacillus salivarius BL 3123 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open
Primary Purpose: Other
Official Title: Behavior of Various Galenic Forms of a Probiotic in the Digestive Tract
Actual Study Start Date : April 6, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Survival rate of Lactobacillus salivarius [ Time Frame: 7 days ]
    Measured by qPCR and determination of CFU in gastric content and in stools for each galenic form.


Secondary Outcome Measures :
  1. Probiotic residual amount in control healthy volunteer [ Time Frame: 10 days ]
    Measured by qPCR and determination of CFU

  2. Probiotic residual amount in ostomy pouch [ Time Frame: 8 days ]
    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.

  3. Ileal microbiota composition [ Time Frame: 8 days ]
    Patients with ostomy pouch

  4. Potential occurrence of digestive symptoms or extra-digestive [ Time Frame: 8 days ]
    Nausea, bloating, flatulence, abdominal pain, intestinal transit modification

  5. Comparison of residual probiotic amount between in vivo and in vitro collection in the stomach, ileon and in stools [ Time Frame: 8 days ]
    Measured by qPRC and determination of CFU number



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143400


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
Contact: Corinne BOUTELOUP, MD cbouteloup@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, Auvergne, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Contact: Corinne BOUTELOUP, MD       cbouteloup@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
3i nature
European Regional Development Fund
Université d'Auvergne

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03143400     History of Changes
Other Study ID Numbers: CHU-322
2016-A00597-44 ( Other Identifier: 2016-A00597-44 )
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Probiotics
Galenic form
Digestive tract
Intestinal microbiota
Lactobacillus salivarius