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Resolvin D1 as Biomarker of Probiotics Efficacy in IBS-C (EPORE)

Primary Purpose

Irritable Bowel Syndrome With Constipation

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Probiotics mixture

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Constipation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CEN Nutriment

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Probiotics mixture

Arm Description

Daily supplementation with a mixture of probiotics for 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of the severity of addominal pain

Mesured by the Abdominal pain domain of the IBS-SSS (Irritable Bowel Syndrome-Severity Scale Scoring) score compared to the baseline. Minimum (best condition) : 0 to maximum (worse condition): 100

Change of the number of days with abdominal pain

Mesured by the Number of days with abdominal pain domain of the IBS-SSS (Irritable Bowel Syndrome-Severity Scale Scoring) score compared to the baseline. Minimum (best condition) : 0 to maximum (worse condition): 100

Change of the severity of abdominal distension (bloating)

Mesured by the bloating-distension domain of the IBS-SSS (Irritable Bowel Syndrome-Severity Scale Scoring) score compared to the baseline. Minimum (best condition) : 0 to maximum (worse condition): 100

Change of the satisfaction with bowel habits

Mesured by the satisfaction with bowel habits domain of the IBS-SSS (Irritable Bowel Syndrome-Severity Scale Scoring) score compared to the baseline. Minimum (best condition) : 0 to maximum (worse condition): 100

Change of the IBS-related quality of life

Mesured by the IBS related quality of life domain of the IBS-SSS (Irritable Bowel Syndrome-Severity Scale Scoring) score compared to the baseline. Minimum (best condition) : 0 to maximum (worse condition): 100

Global assessment of symptoms relief

Measured by the Subject's Global Assessment (SGA) of Relief, compared to the baseline

Change of Resolvin-D1 levels

Blood measurement of resolvin-D1 compared to the baseline

Change of CPRu (C Reactive Protein-ultrasensitive) levels

Blood measurement of C Reactive Protein ultrasensitive compared to the baseline

Change of the intestinal microbiota

Biological parameter : Fecal microbiota measured by 16S rRNA gene sequencing compared to baseline

Change of the stool frequency

Patient-reported number of stools using an e-diary, compared to baseline

Change of the stools consistency

Patient-reported stools consistency by the Bristol Stool Scale, using an e-diary, compared to baseline

Change of the Quality of Life

Measured by Medical Outcomes Study Short-Form General Health Survey Short Form-12 compared to baseline

Change of number of drugs consumption to alleviate the IBS-C symptoms

Patient-reported drug (laxative, spasmolytics) consumption using an e-diary, compared to baseline

Assessing the relationship between resolvin D1 levels and symptoms severity mesured by IBS-SSS symptoms scores

Regression analysis

Assessing the relationship between baseline resolvin D1 levels and response to the probiotics supplementation measured by the responders rate (outcome 17)

Regression analysis

Assessing the responders rate

Number of patients with a decrease in the weekly average of worst abdominal pain in the past 24 hours score (measured daily) of at least 30 percent compared with baseline weekly average and a stool Frequency Weekly Responder is defined as a patient who experiences an increase of at least one complete stool bowel movement per week from baseline.

Assessing the relationship between baseline microbiota and response to the probiotics supplementation measured by the responders rate (outcome 17)

Regression analysis

Assessing the tolerance of the probiotics mixture

Adverse reactions analysis

Assessing the global improvement

Measured by the patient global impression of improvement

Assessing the satisfaction regarding the mixture of probiotics

Measured by a 5 points Likert scale 0 : worse satisfaction to 5 : better satisfaction

Full Information

NCT ID

NCT04997057

First Posted

July 19, 2021

Last Updated

March 1, 2023

Sponsor

CEN Biotech

Collaborators

PiLeJe

1. Study Identification

Unique Protocol Identification Number

NCT04997057

Brief Title

Resolvin D1 as Biomarker of Probiotics Efficacy in IBS-C

Acronym

EPORE

Official Title

Effect of a Mixture of Probiotics (Lactibiane Reference) in Patients With Irritable Bowel Syndrome Predominantly Constipation and Assessment of a Potential Biomarker (Resolvin D1): an Exploratory Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

January 4, 2022 (Actual)

Primary Completion Date

December 9, 2022 (Actual)

Study Completion Date

December 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CEN Biotech

Collaborators

PiLeJe

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome With Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Quasi-experimental study: post-treatment versus baseline comparison

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotics mixture

Arm Type

Other

Arm Description

Daily supplementation with a mixture of probiotics for 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotics mixture

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of the severity of IBS-C symptoms

Description

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

Time Frame

At weeks 0, 4, 8 and 12

Secondary Outcome Measure Information:

Title

Change of the severity of addominal pain

Description

Mesured by the Abdominal pain domain of the IBS-SSS (Irritable Bowel Syndrome-Severity Scale Scoring) score compared to the baseline. Minimum (best condition) : 0 to maximum (worse condition): 100

Time Frame

At weeks 4, 8 and 12

Title

Change of the number of days with abdominal pain

Description

Time Frame

At weeks 4, 8 and 12

Title

Change of the severity of abdominal distension (bloating)

Description

Time Frame

At weeks 4, 8 and 12

Title

Change of the satisfaction with bowel habits

Description

Time Frame

At weeks 4, 8 and 12

Title

Change of the IBS-related quality of life

Description

Time Frame

At weeks 4, 8 and 12

Title

Global assessment of symptoms relief

Description

Measured by the Subject's Global Assessment (SGA) of Relief, compared to the baseline

Time Frame

At weeks 4, 8 and 12

Title

Change of Resolvin-D1 levels

Description

Blood measurement of resolvin-D1 compared to the baseline

Time Frame

At weeks 8 and 12

Title

Change of CPRu (C Reactive Protein-ultrasensitive) levels

Description

Blood measurement of C Reactive Protein ultrasensitive compared to the baseline

Time Frame

At weeks 8 and 12

Title

Change of the intestinal microbiota

Description

Biological parameter : Fecal microbiota measured by 16S rRNA gene sequencing compared to baseline

Time Frame

At weeks 6 and 12

Title

Change of the stool frequency

Description

Patient-reported number of stools using an e-diary, compared to baseline

Time Frame

At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Title

Change of the stools consistency

Description

Patient-reported stools consistency by the Bristol Stool Scale, using an e-diary, compared to baseline

Time Frame

At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

Title

Change of the Quality of Life

Description

Measured by Medical Outcomes Study Short-Form General Health Survey Short Form-12 compared to baseline

Time Frame

At weeks 4, 8 and 12

Title

Change of number of drugs consumption to alleviate the IBS-C symptoms

Description

Patient-reported drug (laxative, spasmolytics) consumption using an e-diary, compared to baseline

Time Frame

At weeks 4, 8 and 12

Title

Assessing the relationship between resolvin D1 levels and symptoms severity mesured by IBS-SSS symptoms scores

Description

Regression analysis

Time Frame

At week 12

Title

Assessing the relationship between baseline resolvin D1 levels and response to the probiotics supplementation measured by the responders rate (outcome 17)

Description

Regression analysis

Time Frame

At week 12

Title

Assessing the responders rate

Description

Time Frame

At weeks 4, 8 and 12

Title

Assessing the relationship between baseline microbiota and response to the probiotics supplementation measured by the responders rate (outcome 17)

Description

Regression analysis

Time Frame

At week 12

Title

Assessing the tolerance of the probiotics mixture

Description

Adverse reactions analysis

Time Frame

At weeks 6 and 12

Title

Assessing the global improvement

Description

Measured by the patient global impression of improvement

Time Frame

At weeks 4, 8 and 12

Title

Assessing the satisfaction regarding the mixture of probiotics

Description

Measured by a 5 points Likert scale 0 : worse satisfaction to 5 : better satisfaction

Time Frame

At weeks 4, 8 and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GABRIEL PERLEMUTER, PR

Organizational Affiliation

Hospital Antoine-Béclère

Official's Role

Study Director

Facility Information:

Facility Name

CEN Nutriment

City

Dijon

State/Province

Bourgogne

ZIP/Postal Code

21000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Resolvin D1 as Biomarker of Probiotics Efficacy in IBS-C

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