Healthy VolunteerPROBIOSINNCT03143400
Behavior of Various Galenic Forms of a Probiotic in the Digestive Tract.
A study testing Lactobacillus salivarius BL 3123 in people with Healthy Volunteer and Terminal Ileostomy, run by University Hospital, Clermont-Ferrand at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Terminal Ileostomy
- What is being tested?
- Lactobacillus salivarius BL 3123
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2017to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Corinne BOUTELOUP, MD contact
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Corinne BOUTELOUP, MD, cbouteloup@chu-clermontferrand.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteer, Terminal Ileostomy
- Being tested
- Lactobacillus salivarius BL 3123
- Keywords
- Probiotics, Galenic form, Digestive tract, Intestinal microbiota, Lactobacillus salivarius
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Lactobacillus salivarius BL 3123 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate of Lactobacillus salivarius
Measured by qPCR and determination of CFU in gastric content and in stools for each galenic form.
Measured: 7 days
Secondary outcomes (5)
Probiotic residual amount in control healthy volunteer
Measured by qPCR and determination of CFU
Measured: 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.
Measured: 8 days
Ileal microbiota composition
Patients with ostomy pouch
Measured: 8 days
Potential occurrence of digestive symptoms or extra-digestive
Nausea, bloating, flatulence, abdominal pain, intestinal transit modification
Measured: 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
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start6 Apr 2017
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- 3i nature, European Regional Development Fund, Université d'Auvergne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143400
- Sponsor's protocol ID
- CHU-322
- Other IDs
- 2016-A00597-44
- Acronym
- PROBIOSIN
- Status last verified
- Apr 2018
- First submitted
- 4 May 2017
- Last updated
- 1 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior of Various Galenic Forms of a Probiotic in the Digestive Tract
- ClinicalTrials.gov ID
- NCT03143400
- Acronym / sponsor ID
- PROBIOSIN / CHU-322
- Conditions
- Healthy Volunteer, Terminal Ileostomy
- Keywords
- Probiotics, Galenic form, Digestive tract, Intestinal microbiota, Lactobacillus salivarius
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- 3i nature, European Regional Development Fund, Université d'Auvergne
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Active comparator | Drug: Lactobacillus salivarius BL 3123Healthy 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 | Active comparator | Drug: Lactobacillus salivarius BL 3123Ileostomized 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus salivarius BL 3123Two 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. | Drug | Healthy volunteers, Ileostomized patients |
Primary outcome
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.
5 secondary outcomes
Probiotic residual amount in control healthy volunteer
Time frame: 10 days
Probiotic residual amount in ostomy pouch
Time frame: 8 days
Ileal microbiota composition
Time frame: 8 days
Potential occurrence of digestive symptoms or extra-digestive
Time frame: 8 days
Comparison of residual probiotic amount between in vivo and in vitro collection in the stomach, ileon and in stools
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne BOUTELOUP, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus salivarius BL 3123 in people with Healthy Volunteer and Terminal Ileostomy, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate of Lactobacillus salivarius (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.