Diarrhea Predominant Irritable Bowel SyndromePILATENCT02728063

Lactibiane Tolérance® in Individuals Suffering From Irritable Bowel Syndrome With Diarrheal Predominance

A study testing Lactibiane Tolerance in people with Diarrhea Predominant Irritable Bowel Syndrome, run by PiLeJe at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objective of the study is to evaluate the effect on intestinal permeability of a supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from irritable bowel syndrome (IBS) with diarrhea predominance. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diarrhea Predominant Irritable Bowel Syndrome
What is being tested?: Lactibiane Tolerance
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteFrance
Study dates: 11 May 2016to 11 Apr 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age from 18 to 75;
With symptoms of IBS with predominant diarrhea according to the Rome III criteria;
For women of childbearing age: effective contraception and agreement to keep it throughout the study;
General and mental health compatible with participation in the study and to be followed as an outpatient in the opinion of the investigator: no clinically significant and relevant abnormality according to medical history and physical examination;
Agreeing to maintain their lifestyle during the study (same eating habits and physical activity);
Able and willing to participate in research in accordance with the protocol procedures particularly regarding consumption of the product under consideration and having signed an informed consent form dated;
Belonging to a social security scheme;
Willing to be included in the file of volunteers participating in biomedical research.

Who cannot join

Having a history of hypersensitivity to any of the ingredients of the product under consideration;
Having a history of hypersensitivity to fluorescein and / or red carmine (E120 food coloring);
With immunodeficiency or with a severe or progressive disease (cardiac, pulmonary, hepatic, renal, hematologic, neoplastic, or infectious);
With acute or severe chronic disease (chronic alcoholism, drug addiction) found incompatible with participation in the study by the investigator;
Suffering from a metabolic disorder or a chronic inflammatory digestive disease affecting the intestinal transit or absorption of nutrients such as diabetes, hyperthyroidism, celiac disease or Crohn's disease;
Having a medical history or current condition that, according to the investigator, may interfere with the results of the study or expose the subject to additional risk;

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Currently under medication or food supplement treatment, according to the investigator, may interfere with the results of the study or stopped within too short before inclusion in V1 (less than a month for antibiotics, pre and probiotics, less than 14 days for antidiarrheal, steroidal anti-inflammatories, NSAIDs, aspirin, antihistamines and drugs. treatment with maximum 2 concomitant psychotropic can be tolerated only if it exists for more than 3 months before inclusion);
Having a lifestyle incompatible with the study by the investigator;
Woman during pregnancy or breastfeeding or planning to become pregnant within 2 months;
Planning to travel and hold during the study period or impossible to contact in case of emergency;
Having a psychological or linguistic inability to understand and sign the informed consent;
Participating in another clinical trial or exclusion period of a previous clinical trial;
Having received over the past 12 months, no more than 4,500 euros in payment for participation in clinical trials;
Under legal protection (guardianship, trusteeship) or deprived of his rights under the administrative or judicial decision.

Trial locations and contacts

1 site in 1 country.

France1 site

CHU-Hôtel-Dieu, Service d'Hépato-gastro-entérologie
Nantes, 44093

Other trials in France

About this study

Official title: Effect of a Mixture of Probiotics, Lactibiane Tolérance® on Intestinal Permeability in Individuals Suffering From Irritable Bowel Syndrome With Diarrheal Predominance

Secondary objectives of the study are to evaluate the effects of supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from IBS with diarrhea predominance on intestinal permeability, inflammation of the digestive tract, symptoms and comfort.

Single-center study in single open arms: 30 volunteer adults suffering from Irritable Bowel Syndrome (IBS) with diarrhea predominance and matching the criteria of inclusion and non-inclusion listed below.

Read the detailed description

single-center pilot study in single open arm:

2 to 6 weeks before enrollment: a screening visit (visit 0 [V0]) is carried out for verification of eligibility. time between V0 and V1 is a wash-out period with a duration decided by the physician (max 8 weeks).
The experimental phase is composed of 2 visits (Visit 1 [V1] and Visit 2 [V2]) separated by 28 days (± 2 days) : from V1 to V2 patients are taking the product Lactibiane Tolérance®.
V1 and V2 each include collection of stools, a blood sample, questionnaires on abdominal symptoms and quality of life, dynamic test of absorption of lactulose / mannitol to evaluate the intestinal permeability, recto-sigmoidoscopy with confocal endomicroscopy for in-vivo study of fluorescein leakage in the lamina propria and biopsies for ex-vivo measurements.
"carmine red" test for the evaluation of intestinal transit speed is carried out the week before V1 and V2 (at least 72 hours before the visit). Questionnaires on abdominal symptoms as well as the frequency and consistency of stools are filled during the 7 days before V1 and V2 before.

Conditions: Diarrhea Predominant Irritable Bowel Syndrome
Being tested: Lactibiane Tolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lactibiane ToleranceDietary supplement
probiotics

Study groups in NCT02728063
Study group	Role	What they receive
Single arm	Experimental	Supplementation with Lactibiane Tolerance Receives: Dietary Supplement: Lactibiane Tolerance

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline of intestinal permeability
Evolution between V1 and V2 of intestinal permeability evaluated by the lactulose-mannitol test according to the slope of urinary excretion of ingested lactulose percentage (calculated by linear regression) during the period representing the passage into the small intestine (2 to 4 hours after ingestion of lactulose-mannitol mixture).
Measured: at day 0 and day 28

Secondary outcomes (16)

Change from baseline of intestinal permeability - secondary 1
Evolution of slope percentages urinary excretion (UE) of ingested mannitol ([M]) (calculated by linear regression) during the period representing the Passage Into the Small Intestine (PISI) (2 to 4 hours (h) after ingestion of [L]-[M] mixture)
Measured: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 2
Evolution of the ratio between the slopes of the UE percentages of lactulose ([L]) and [M] ingested during the PISI (2 to 4h after ingestion of lactulose-mannitol mixture)
Measured: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 3
Evolution of the percentage of UE of [L] ingested on the excretion of ingested [M] during the period representing the PISI (2 to 4h after ingestion)
Measured: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 4
Evolution of the UE percentage of [L] ingested on the UE of ingested [M] each lap of the period representing the PISI
Measured: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 5
Evolution of he percent UE of [L] ingested on the UE of ingested [M] during the period representing the passage in the colon (between 4 and 5h after ingestion)
Measured: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 6
Evolution of the percent UE of [L] ingested on the UE of ingested [M] during the period of 5h after ingestion
Measured: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 7
Evolution of the UE percentage of [L] ingested on the UE of ingested [M] during the transition period representative of the stomach to the small intestine (between 0 and 2h after
Measured: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 8
Evolution of the Percentage of UE of [L] and [M] ingested during the period representing the PISI (2 to 4h after ingestion)
Measured: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 9
Evolution of the Percentage of UE of [L] and [M] ingested during a period of 5h after ingestion
Measured: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 10
Evolution of the Percentage of UE of [L] and [M] ingested each 5h lap
Measured: at day 0 and day 28
Change from the baseline of the inflammatory status - secondary 11
Evolution between V1 and V2 of inflammatory status by fecal calprotectin
Measured: at day 0 and day 28
Change from the baseline of the symptomatology - secondary 12
Time to onset of the first colored red stool after taking carmine red capsules (minutes)
Measured: at week 0 and week 4
Change from the baseline of the symptomatology - secondary 13
Average intensity of 7 days of the worst abdominal pain on Likert scale (11 points)
Measured: at week 0 and week 4
Change from the baseline of the symptomatology - secondary 14
Medium intensity of 7 days of abdominal discomfort on Likert scale (11 points)
Measured: at week 0 and week 4
Change from the baseline of the symptomatology - secondary 15
Stool consistency average of 7 days after Bristol Stool Scale (BSS)
Measured: at week 0 and week 4
Change from the baseline of the symptomatology - secondary 16
Mean daily stool frequency of 7 days after BSS quiz
Measured: at week 0 and week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 201611 Apr 2018

First posted5 Apr 2016 (estimated)
Study start11 May 2016
Primary completion11 Apr 2018
Study completion11 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diarrhea Predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02728063
Sponsor's protocol ID: PEC15144
Acronym: PILATE
Status last verified: Feb 2021
First submitted: 8 Mar 2016
Last updated: 23 Feb 2021
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diarrhea Predominant Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of a Mixture of Probiotics, Lactibiane Tolérance® on Intestinal Permeability in Individuals Suffering From Irritable Bowel Syndrome With Diarrheal Predominance
ClinicalTrials.gov ID: NCT02728063
Acronym / sponsor ID: PILATE / PEC15144
Conditions: Diarrhea Predominant Irritable Bowel Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: PiLeJeIndustry (pharma, biotech, devices)
Study start: 11 May 2016 (actual)
Primary completion: 11 Apr 2018 (actual)
Study completion: 11 Apr 2018 (actual)
First posted: 5 Apr 2016 (estimated)
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.

Detailed description

single-center pilot study in single open arm:

2 to 6 weeks before enrollment: a screening visit (visit 0 [V0]) is carried out for verification of eligibility. time between V0 and V1 is a wash-out period with a duration decided by the physician (max 8 weeks).
The experimental phase is composed of 2 visits (Visit 1 [V1] and Visit 2 [V2]) separated by 28 days (± 2 days) : from V1 to V2 patients are taking the product Lactibiane Tolérance®.
V1 and V2 each include collection of stools, a blood sample, questionnaires on abdominal symptoms and quality of life, dynamic test of absorption of lactulose / mannitol to evaluate the intestinal permeability, recto-sigmoidoscopy with confocal endomicroscopy for in-vivo study of fluorescein leakage in the lamina propria and biopsies for ex-vivo measurements.
"carmine red" test for the evaluation of intestinal transit speed is carried out the week before V1 and V2 (at least 72 hours before the visit). Questionnaires on abdominal symptoms as well as the frequency and consistency of stools are filled during the 7 days before V1 and V2 before.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single arm	Experimental	Dietary Supplement: Lactibiane ToleranceSupplementation with Lactibiane Tolerance

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age from 18 to 75;
With symptoms of IBS with predominant diarrhea according to the Rome III criteria;
For women of childbearing age: effective contraception and agreement to keep it throughout the study;
General and mental health compatible with participation in the study and to be followed as an outpatient in the opinion of the investigator: no clinically significant and relevant abnormality according to medical history and physical examination;
Agreeing to maintain their lifestyle during the study (same eating habits and physical activity);

Key exclusion criteria (14 listed)

Having a history of hypersensitivity to any of the ingredients of the product under consideration;
Having a history of hypersensitivity to fluorescein and / or red carmine (E120 food coloring);
With immunodeficiency or with a severe or progressive disease (cardiac, pulmonary, hepatic, renal, hematologic, neoplastic, or infectious);
With acute or severe chronic disease (chronic alcoholism, drug addiction) found incompatible with participation in the study by the investigator;
Suffering from a metabolic disorder or a chronic inflammatory digestive disease affecting the intestinal transit or absorption of nutrients such as diabetes, hyperthyroidism, celiac disease or Crohn's disease;

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
Lactibiane Toleranceprobiotics	Dietary supplement	Single arm

Primary outcome

Change from baseline of intestinal permeability
Time frame: at day 0 and day 28
Evolution between V1 and V2 of intestinal permeability evaluated by the lactulose-mannitol test according to the slope of urinary excretion of ingested lactulose percentage (calculated by linear regression) during the period representing the passage into the small intestine (2 to 4 hours after ingestion of lactulose-mannitol mixture).

16 secondary outcomes

Change from baseline of intestinal permeability - secondary 1
Time frame: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 2
Time frame: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 3
Time frame: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 4
Time frame: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 5
Time frame: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 6
Time frame: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 7
Time frame: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 8
Time frame: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 9
Time frame: at day 0 and day 28
Change from baseline of intestinal permeability - secondary 10
Time frame: at day 0 and day 28
Change from the baseline of the inflammatory status - secondary 11
Time frame: at day 0 and day 28
Change from the baseline of the symptomatology - secondary 12
Time frame: at week 0 and week 4
Change from the baseline of the symptomatology - secondary 13
Time frame: at week 0 and week 4
Change from the baseline of the symptomatology - secondary 14
Time frame: at week 0 and week 4
Change from the baseline of the symptomatology - secondary 15
Time frame: at week 0 and week 4
Change from the baseline of the symptomatology - secondary 16
Time frame: at week 0 and week 4

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
Individual participant dataSharing planned: No

Related trials for Diarrhea Predominant Irritable Bowel Syndrome

Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
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Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome
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Clinical Efficacy and Safety of Jingfang Granules in Treating Diarrhea-Predominant Irritable Bowel Syndrome With Cold-Dampness Disturbing Spleen Syndrome
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Not yet recruitingPhase 3
Phase III Clinical Trial of Changji'an Capsules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver-Qi Invading Spleen Syndrome)
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Recruiting
Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome
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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.

Coron Emmanuel, Pr. principal investigator

Nantes University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lactibiane Tolerance in people with Diarrhea Predominant Irritable Bowel Syndrome, run by PiLeJe 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 8 inclusion and 14 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: finished, as of the sponsor's last update on 23 Feb 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of intestinal permeability (time frame: at day 0 and day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02728063.

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 23 Feb 2021.