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

NCT04997057 | Completed

• 1 other identifier: C1674
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome With Constipation

Outcome Measures

Primary Outcomes (1)

• Change of the severity of IBS-C symptoms

  Measured by the composite IBS-SSS (Irritable Bowel Syndrome-Severity Scale Scoring) system, compared to the baseline IBS-SSS value. Minimum : 0 (best condition) to maximum (worse condition): 500

  At weeks 0, 4, 8 and 12

Secondary Outcomes (20)

• Change of the severity of addominal pain

  At weeks 4, 8 and 12

• Change of the number of days with abdominal pain

  At weeks 4, 8 and 12

• Change of the severity of abdominal distension (bloating)

  At weeks 4, 8 and 12

• Change of the satisfaction with bowel habits

  At weeks 4, 8 and 12

• Change of the IBS-related quality of life

  At weeks 4, 8 and 12

Study Arms (1)

Probiotics mixture

OTHER

Daily supplementation with a mixture of probiotics for 12 weeks

Dietary Supplement: Probiotics mixture

Interventions

Probiotics mixture 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

Probiotics mixture

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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 ;
• Excessive smoking or drinking ;
• Having or planning bariatric surgery,
• With known pathologies affecting gut function ;
• With a deviant eating behavior,
• Under legal protection,
• Already included in a clinical trial,
• With severely impaired physical/psychological health may affect study participation.

Sponsors & Collaborators

• CEN Biotech: lead
• PiLeJe: collaborator

Study Sites (1)

CEN Nutriment

Dijon, Bourgogne-Franche-Comté, 21000, France

Location

Study Officials

• GABRIEL PERLEMUTER, PR

  Hospital Antoine-Béclère

  STUDY DIRECTOR

Study Design

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

Model Details: Quasi-experimental study: post-treatment versus baseline comparison

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 9, 2021
• Study Start: January 4, 2022
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: December 26, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)