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

NCT02728063 | Completed

• 1 other identifier: PEC15144
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diarrhea Predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Change from baseline of intestinal permeability - secondary 1

  at day 0 and day 28

• Change from baseline of intestinal permeability - secondary 2

  at day 0 and day 28

• Change from baseline of intestinal permeability - secondary 3

  at day 0 and day 28

• Change from baseline of intestinal permeability - secondary 4

  at day 0 and day 28

• Change from baseline of intestinal permeability - secondary 5

  at day 0 and day 28

Other Outcomes (2)

• Parameters measured ex vivo from colonic biopsies placed in Ussing chamber : change from baseline of paracellular permeability

  at day 0 and day 28

• Parameters measured ex vivo from colonic biopsies placed in Ussing : change from baseline of transcellular permeability

  at day 0 and day 28

Study Arms (1)

Single arm

EXPERIMENTAL

Supplementation with Lactibiane Tolerance

Dietary Supplement: Lactibiane Tolerance

Interventions

Lactibiane Tolerance DIETARY_SUPPLEMENT

probiotics

Single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• 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.

Sponsors & Collaborators

• PiLeJe: lead

Study Sites (1)

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

Nantes, 44093, France

Location

Study Officials

• Coron Emmanuel, Pr.

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: April 5, 2016
• Study Start: May 11, 2016
• Primary Completion: April 11, 2018
• Study Completion: April 11, 2018
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)