A Multistrain Probiotic in Patients With Irritable Bowel Syndrome With Predominant Constipation

NCT ID: NCT04997057

Last Updated: 2023-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2022-12-09

Brief Summary

Probiotics efficacy is mainly assessed by subjective endpoints such as the FDA responder rate or global relief, which partly explain contradictory results obtained in clinical trials with probiotic bacteria. Objective biomarkers of IBS will allow to measure the efficacy of probiotics. In the case of IBS-C, serum resolvin-D1 appears to be an interesting candidate due to its non-invasive and discriminating character compared to a healthy population. It is, inversely correlated with the severity of symptoms. Resolvin-D1 modulates the duration and intensity of inflammation by regulating the transcription of cytokines, chemokines and their receptors as well as other proteins involved in inflammation. Resolvin D1 could serve as a predictor of probiotic response based on its baseline value.

Detailed Description

Resolvin D1 levels will be measured in patients with IBS-C as defined by the Rome IV criteria before 6 and 12 weeks after supplementation with a mixture of probiotics. The progression of IBS-C symptoms will also be assessed throughout the study.

The correlation with resolvin D1 levels and the severity of IBS symptoms will be investigated. The efficacy of the probiotic mixture in relieving the symptoms of IBS-C will be measured and compared based on the levels of resolvin D1.

Conditions

Irritable Bowel Syndrome With Constipation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Probiotics mixture

Daily supplementation with a mixture of probiotics for 12 weeks

Group Type: OTHER

Probiotics mixture

Intervention Type: DIETARY_SUPPLEMENT

12 weeks of daily supplementation with 1 g of probiotics mixture (4.10exp9 colony forming unit/g) containing:

• Bifidobacterium longum LA 101
• Lactobacillus helveticus La 102
• Lactococcus lactis LA 103
• Streptococcus thermophilus LA 104

Interventions

Probiotics mixture

12 weeks of daily supplementation with 1 g of probiotics mixture (4.10exp9 colony forming unit/g) containing:

• Bifidobacterium longum LA 101
• Lactobacillus helveticus La 102
• Lactococcus lactis LA 103
• Streptococcus thermophilus LA 104

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Irritable Bowel Syndrome with constipation (IBS-C) according to Rome IV criteria ;
• IBS-SSS between 175-300 in the last 10 days ;
• Have experienced abdominal pain ≥ 40 according to the IBS-SSS questionnaire (abdominal pain item) during the last 10 days ;
• Whose abdominal pain / discomfort has had a significant impact on daily life during the past 10 days (impact ≥2 on a 5-point likert scale (from 0: no impact to 5: extreme impact) ;
• Ability to understand instructions and complete questionnaires Nurstrial APP.
• Affiliate or beneficiary of a social security ;
• Having given their free, informed and written consent.

Exclusion Criteria

• CPRu > 10 mg/l
• Pregnant or breastfeeding woman, woman planning a pregnancy during the study period ;
• Intolerance or proven food allergy ;
• BMI <18.5 kg / m2 or BMI> 35 kg / m2 ;
• Diagnosis or known history of IBS-D, IBS-M, or unclassified forms of IBS, or other gastrointestinal pathologies ;
• With current first-line IBS-C treatment or second-line treatment ;
• alternative non pharmacological treatment ;
• Drug treatment affecting visceral sensitivity or intestinal transit ;
• dietary modification (exclusion of FODMAPs, prebiotic) or lifestyle ;
• Excessive smoking or drinking ;
• Having or planning bariatric surgery,
• With known pathologies affecting gut function ;
• With a deviant eating behavior,
• Treated with antibiotics in the 3 months preceding inclusion,
• Under legal protection,
• Already included in a clinical trial,
• With severely impaired physical/psychological health may affect study participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PiLeJe

INDUSTRY

Sponsor Role: collaborator

CEN Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GABRIEL PERLEMUTER, PR

Role: STUDY_DIRECTOR

Hospital Antoine-Béclère

Locations

CEN Nutriment

Dijon, Bourgogne-Franche-Comté, France

Countries

France

Other Identifiers

C1674

Identifier Type: -

Identifier Source: org_study_id