Irritable Bowel SyndromeNCT05213910
Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains
A study testing Lactichoc and Stool sampling in people with Irritable Bowel Syndrome, run by PiLeJe at 1 site in France.
Trial summary
The aim of this study is to determine the impact of a 10-day treatment with Lactichoc® on irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Lactichoc and Stool sampling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteFrance
- Study dates
- 4 Sep 2018to 15 Nov 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having IBS symptomatology meeting the Rome IV criteria;
- Having a IBS-SSS score ≥150 ;
- In a state of general and mental health compatible with participation in the study ;
- Agreeing to maintain their lifestyle during the study (same dietary and physical activity habits) ;
- Willing to take stool samples;
- Able and willing to participate in the research by complying with the protocol procedures, especially regarding the consumption of the study product;
- Having electronic tools (computer, tablet...) and an internet connection, allowing him/her to fill out the self-questionnaires of the study online;
- Affiliated to a social security system.
Who cannot join
- Have a history of hypersensitivity to any of the ingredients of the study product;
- Under antibiotic treatment, or having stopped it for less than 14 days;
- Under dietary supplementation (prebiotics or probiotics) or having stopped it for less than one month;
- Having initiated or modified a background treatment for a comorbidity for less than one month, or planning to initiate it during the study, or planning to interrupt it during the study;
- Having a lifestyle incompatible with the study as determined by the investigator;
- Women who are pregnant or breastfeeding or who intend to become pregnant within the next 2 months;
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- Planning to travel extensively during the study period or unable to be contacted in case of emergency;
- Psychologically or linguistically unable to understand and sign the informed consent;
- Participating in another clinical trial or on an exclusion period from a previous clinical trial;
- Under legal protection (guardianship, curatorship) or deprived of their rights following an administrative or judicial decision.
Trial locations and contacts
1 site in 1 country.
France1 site
General practitioners or gastroenterologists consulting in french private offices
Paris
About this study
The aim of this study is to determine the impact of a 10-day treatment with Lactichoc® on irritable bowel syndrome.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Lactichoc, Stool sampling
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactichocDietary supplement
dosage form: mix of 8 strains containing 1.2x10^11 CFU frequency, and duration: 2 capsules/day during 10 days
Stool samplingOther
3 stool samples are taken during the study (D0, D10 and D30)
| Study group | Role | What they receive |
|---|---|---|
| Patients using the product | Experimental | Not described Receives: Dietary Supplement: Lactichoc; Other: Stool sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the severity of functional bowel disorders
The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Measured: 10 days
Secondary outcomes (12)
Evolution of the severity of functional bowel disorders
The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Measured: Between V2 (Day10) and Day30 (20 days)
Description of the symptomatology
- 10-day average stool consistency according to the Bristol Stool Scale;
Measured: V1(Day0), V2 (Day10) and Day30
Description of the symptomatology
- 10-day average daily stool frequency;
Measured: V1(Day0), V2 (Day10) and Day30
Description of the symptomatology
- 10-day average abdominal pain score (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 1b);
Measured: V1(Day0), V2 (Day10) and Day30
Description of the symptomatology
- 10-day global self-assessment of the impact of IBS symptoms (Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) item 4)
Measured: V1(Day0), V2 (Day10) and Day30
Description of quality of life
Evaluated by the GIQLI (Gastrointestinal Quality of Life Index)
Measured: V1(Day0), V2 (Day10) and Day30
Description of the anxiety-depressive disorders
Evaluated by the Hospital Anxiety and Depression (HAD) scale
Measured: V2 (Day10)
Safety (tolerance to treatment)
Calculated with adverse events that may be observed during study period (descriptif results)
Measured: V2 (Day10)
Treatment compliance
By counting treatments returned at the V2 visit
Measured: V2 (Day10)
Global clinical evaluation
Evaluated by the investigator (V2) by a questionnaire
Measured: V2 (Day10)
Global clinical evaluation
Evaluated by the patient (V2 and D30) by a questionnaire
Measured: V2 (Day10) and Day30
Evaluation of the satisfaction concerning the product by a questionnaire
Evaluated by the patient
Measured: Day30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start4 Sep 2018
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dominique DELSART, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213910
- Sponsor's protocol ID
- Pil-LACCB-017
- Status last verified
- Dec 2021
- First submitted
- 13 Dec 2021
- Last updated
- 6 Apr 2022
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains
- ClinicalTrials.gov ID
- NCT05213910
- Acronym / sponsor ID
- Pil-LACCB-017
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 28 Jan 2022 (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.
The aim of this study is to determine the impact of a 10-day treatment with Lactichoc® on irritable bowel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients using the product | Experimental | Dietary Supplement: Lactichoc, Other: Stool sampling |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Having IBS symptomatology meeting the Rome IV criteria;
- Having a IBS-SSS score ≥150 ;
- In a state of general and mental health compatible with participation in the study ;
- Agreeing to maintain their lifestyle during the study (same dietary and physical activity habits) ;
- Willing to take stool samples;
Key exclusion criteria (10 listed)
- Have a history of hypersensitivity to any of the ingredients of the study product;
- Under antibiotic treatment, or having stopped it for less than 14 days;
- Under dietary supplementation (prebiotics or probiotics) or having stopped it for less than one month;
- Having initiated or modified a background treatment for a comorbidity for less than one month, or planning to initiate it during the study, or planning to interrupt it during the study;
- Having a lifestyle incompatible with the study as determined by the investigator;
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 |
|---|---|---|
| Lactichocdosage form: mix of 8 strains containing 1.2x10^11 CFU frequency, and duration: 2 capsules/day during 10 days | Dietary supplement | Patients using the product |
| Stool sampling3 stool samples are taken during the study (D0, D10 and D30) | Other | Patients using the product |
Primary outcome
Evolution of the severity of functional bowel disorders
Time frame: 10 days
The severity of functional bowel syndrome is evaluated by Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
12 secondary outcomes
Evolution of the severity of functional bowel disorders
Time frame: Between V2 (Day10) and Day30 (20 days)
Description of the symptomatology
Time frame: V1(Day0), V2 (Day10) and Day30
Description of the symptomatology
Time frame: V1(Day0), V2 (Day10) and Day30
Description of the symptomatology
Time frame: V1(Day0), V2 (Day10) and Day30
Description of the symptomatology
Time frame: V1(Day0), V2 (Day10) and Day30
Description of quality of life
Time frame: V1(Day0), V2 (Day10) and Day30
Description of the anxiety-depressive disorders
Time frame: V2 (Day10)
Safety (tolerance to treatment)
Time frame: V2 (Day10)
Treatment compliance
Time frame: V2 (Day10)
Global clinical evaluation
Time frame: V2 (Day10)
Global clinical evaluation
Time frame: V2 (Day10) and Day30
Evaluation of the satisfaction concerning the product by a questionnaire
Time frame: Day30
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 6 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
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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.
Dominique DELSART principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactichoc and Stool sampling in people with Irritable Bowel Syndrome, run by PiLeJe 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 8 inclusion and 10 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 6 Apr 2022. 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?
Evolution of the severity of functional bowel disorders (time frame: 10 days). 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 6 Apr 2022.