Irritable Bowel Syndrome With ConstipationEPORENCT04997057
A Multistrain Probiotic in Patients With Irritable Bowel Syndrome With Predominant Constipation
A study testing Probiotics mixture in people with Irritable Bowel Syndrome With Constipation, run by CEN Biotech at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome With Constipation
- What is being tested?
- Probiotics mixture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2022to 9 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 ;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Probiotics mixture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics mixtureDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Probiotics mixture | Other | Daily supplementation with a mixture of probiotics for 12 weeks Receives: Dietary Supplement: Probiotics mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At weeks 0, 4, 8 and 12
Secondary outcomes (20)
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
Measured: At weeks 4, 8 and 12
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
Measured: At weeks 4, 8 and 12
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
Measured: At weeks 4, 8 and 12
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
Measured: At weeks 4, 8 and 12
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
Measured: At weeks 4, 8 and 12
Global assessment of symptoms relief
Measured by the Subject's Global Assessment (SGA) of Relief, compared to the baseline
Measured: At weeks 4, 8 and 12
Change of Resolvin-D1 levels
Blood measurement of resolvin-D1 compared to the baseline
Measured: At weeks 8 and 12
Change of CPRu (C Reactive Protein-ultrasensitive) levels
Blood measurement of C Reactive Protein ultrasensitive compared to the baseline
Measured: At weeks 8 and 12
Change of the intestinal microbiota
Biological parameter : Fecal microbiota measured by 16S rRNA gene sequencing compared to baseline
Measured: At weeks 6 and 12
Change of the stool frequency
Patient-reported number of stools using an e-diary, compared to baseline
Measured: At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Change of the stools consistency
Patient-reported stools consistency by the Bristol Stool Scale, using an e-diary, compared to baseline
Measured: At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Change of the Quality of Life
Measured by Medical Outcomes Study Short-Form General Health Survey Short Form-12 compared to baseline
Measured: At weeks 4, 8 and 12
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
Measured: At weeks 4, 8 and 12
Assessing the relationship between resolvin D1 levels and symptoms severity mesured by IBS-SSS symptoms scores
Regression analysis
Measured: At week 12
Assessing the relationship between baseline resolvin D1 levels and response to the probiotics supplementation measured by the responders rate (outcome 17)
Regression analysis
Measured: At week 12
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.
Measured: At weeks 4, 8 and 12
Assessing the relationship between baseline microbiota and response to the probiotics supplementation measured by the responders rate (outcome 17)
Regression analysis
Measured: At week 12
Assessing the tolerance of the probiotics mixture
Adverse reactions analysis
Measured: At weeks 6 and 12
Assessing the global improvement
Measured by the patient global impression of improvement
Measured: At weeks 4, 8 and 12
Assessing the satisfaction regarding the mixture of probiotics
Measured by a 5 points Likert scale 0 : worse satisfaction to 5 : better satisfaction
Measured: At weeks 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start4 Jan 2022
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental study: post-treatment versus baseline comparison
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEN Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PiLeJe
- Responsible party
- Sponsor
- Investigators
- GABRIEL PERLEMUTER, PR, Study director, Hospital Antoine-Béclère
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997057
- Sponsor's protocol ID
- C1674
- Acronym
- EPORE
- Status last verified
- Mar 2023
- First submitted
- 19 Jul 2021
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04997057
- Acronym / sponsor ID
- EPORE / C1674
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- CEN BiotechIndustry (pharma, biotech, devices)
- Collaborators
- PiLeJe
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental study: post-treatment versus baseline comparison
| Arm | Type | Receives |
|---|---|---|
| Probiotics mixture | Other | Dietary Supplement: Probiotics mixtureDaily supplementation with a mixture of probiotics for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotics mixture12 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 | Dietary supplement | Probiotics mixture |
Primary outcome
Change of the severity of IBS-C symptoms
Time frame: At weeks 0, 4, 8 and 12
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
20 secondary outcomes
Change of the severity of addominal pain
Time frame: At weeks 4, 8 and 12
Change of the number of days with abdominal pain
Time frame: At weeks 4, 8 and 12
Change of the severity of abdominal distension (bloating)
Time frame: At weeks 4, 8 and 12
Change of the satisfaction with bowel habits
Time frame: At weeks 4, 8 and 12
Change of the IBS-related quality of life
Time frame: At weeks 4, 8 and 12
Global assessment of symptoms relief
Time frame: At weeks 4, 8 and 12
Change of Resolvin-D1 levels
Time frame: At weeks 8 and 12
Change of CPRu (C Reactive Protein-ultrasensitive) levels
Time frame: At weeks 8 and 12
Change of the intestinal microbiota
Time frame: At weeks 6 and 12
Change of the stool frequency
Time frame: At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Change of the stools consistency
Time frame: At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Change of the Quality of Life
Time frame: At weeks 4, 8 and 12
Change of number of drugs consumption to alleviate the IBS-C symptoms
Time frame: At weeks 4, 8 and 12
Assessing the relationship between resolvin D1 levels and symptoms severity mesured by IBS-SSS symptoms scores
Time frame: At week 12
Assessing the relationship between baseline resolvin D1 levels and response to the probiotics supplementation measured by the responders rate (outcome 17)
Time frame: At week 12
Assessing the responders rate
Time frame: At weeks 4, 8 and 12
Assessing the relationship between baseline microbiota and response to the probiotics supplementation measured by the responders rate (outcome 17)
Time frame: At week 12
Assessing the tolerance of the probiotics mixture
Time frame: At weeks 6 and 12
Assessing the global improvement
Time frame: At weeks 4, 8 and 12
Assessing the satisfaction regarding the mixture of probiotics
Time frame: At weeks 4, 8 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GABRIEL PERLEMUTER, PR study director
Hospital Antoine-Béclère
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics mixture in people with Irritable Bowel Syndrome With Constipation, run by CEN Biotech at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the severity of IBS-C symptoms (time frame: At weeks 0, 4, 8 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.