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

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

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.

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.

Study Overview

• Status: Completed
• Conditions: Diarrhea Predominant Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Lactibiane Tolerance

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm; Supplementation with Lactibiane Tolerance	Dietary supplement: Lactibiane Tolerance; probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	at day 0 and day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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	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)	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	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	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)	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	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	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	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)	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)	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)	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)	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	at week 0 and week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parameters measured ex vivo from colonic biopsies placed in Ussing chamber : change from baseline of paracellular permeability	Evolution of the slope ( determined by linear regression ) and area under the curve of evolution of the concentration of sulfonic acid fluorescence (measured in the basolateral chamber ) over time (measured every 30 min for 3 hours )	at day 0 and day 28
Parameters measured ex vivo from colonic biopsies placed in Ussing : change from baseline of transcellular permeability	Evolution of the slope ( calculated by linear regression) and area under the curve of evolution of the concentration of Horse Radish Peroxidase (HRP) (measured in the basolateral chamber ) over time (measured every 30 minutes between 1 and 3 hours) .	at day 0 and day 28

Collaborators and Investigators

• Sponsor: PiLeJe
• Investigators: Principal Investigator: Coron Emmanuel, Pr., CHU Nantes

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2016
• Primary Completion (Actual): April 11, 2018
• Study Completion (Actual): April 11, 2018

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 19, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: PEC15144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No