Irritable Bowel SyndromeLactiplusNCT04324658
Effect and Tolerance of a Probiotic-based Medical Device Administered to Patients With Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome, run by PiLeJe at 1 site in France.
Trial summary
This is an observational, open, longitudinal, multicentre study conducted in France. The study plans to enrol 119 patients with irritable bowel syndrome who will be included by about 50 general practitioners or gastroenterologists consulting in private offices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Lactiplus
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 119 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2019to 26 Jun 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with irritable bowel syndrome
Who may be able to join
- Adult (age ≥ 18 years)
- Suffering from IBS (Rome IV criteria), whatever the predominant stool pattern, i.e recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: Related to defecation; Associated with a change in frequency of stool; Associated with a change in form (appearance) of stool; with symptom onset at least 6 months before diagnosis;
- Having access to electronic tools (computer, tablet…) and an internet connection, allowing him to complete the online self-questionnaire.
Who cannot join
- Presence of clinical signs of alarm such as rectorrhagia, fever or recent unexpected weight loss or patient with suspicion or evidence of diseases that exclude IBS diagnosis: including but not limited to inflammatory gastrointestinal disease (e.g. Crohn's disease, ulcerative colitis), colorectal cancer, celiac disease, hyperthyroidism, intestinal infection, lactose intolerance, other malabsorption syndromes (e.g.: fructose), bile acid malabsorption;
- History of abdominal surgery except appendectomy;
- Allergy or hypersensitivity to one of the ingredients of the medical device;
- Inability to fill self-questionnaires or to understand the information notice (cognitive or linguistic issues);
- Participation to another clinical study or in the exclusion phase of a previous clinical study;
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
France1 site
General practitioners or gastroenterologists consulting in french private offices
Paris
About this study
Official title: Effect and Tolerance of a Probiotic-based Medical Device (Lactiplus®) Administered to Patients With Irritable Bowel Syndrome
This is an observational, open, longitudinal, multicentre study conducted in France.
The study plans to enrol 119 patients with irritable bowel syndrome who will be included by about 50 general practitioners or gastroenterologists consulting in private offices. The treatment, Lactiplus® is a medical device, in the form of capsules containing L. gasseri LA806. The main objective of the study is to assess the effect of a 4-week treatment with the medical device on abdominal pain.
Read the detailed description
The study is designed as an observational post-market follow-up study, to confirm the performance of the medical device in real life conditions and document its safety profile.
The eligible population corresponds to the population that could benefit from the treatment, according to the MD's instructions for use. Non-inclusion criteria prevent from including patients with other pathologies associated with gastro-intestinal troubles, who may beneficiate from more adequate treatments.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Lactiplus
- 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.
LactiplusDevice
capsules containing L. gasseri LA806
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the effect of a 4-week treatment with the medical device on abdominal pain
Measured: 4 weeks
Secondary outcomes (6)
assess the effect of a 4-week treatment with the medical device on digestive troubles
global symptom score, intestinal symptoms (discomfort, distension/bloating, urgency to defecate, bowel habit, incomplete rectal emptying), Francis score, Clinical global impression of improvement
Measured: 4 weeks
assess the effect of a 4-week treatment with the medical device on the patient's quality of life
Measured: 4 weeks
assess the effect of a 4-week treatment with the medical device on the patient's intake of treatments (antidiarrheal, antispasmodic, laxative, pro/prebiotics, analgesics)
Measured: 4 weeks
assess the tolerance of the medical device
Measured: 4 weeks
assess the satisfaction with the medical device
Measured: 4 weeks
assess the observance to the treatment and the intake of other medications
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start30 Jul 2019
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324658
- Sponsor's protocol ID
- PIL-DM-L.PLUS-019
- Acronym
- Lactiplus
- Status last verified
- Sep 2020
- First submitted
- 25 Mar 2020
- Last updated
- 29 Sep 2020
- 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 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Tolerance of a Probiotic-based Medical Device (Lactiplus®) Administered to Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04324658
- Acronym / sponsor ID
- Lactiplus / PIL-DM-L.PLUS-019
- Conditions
- Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 27 Mar 2020 (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.
This is an observational, open, longitudinal, multicentre study conducted in France.
The study plans to enrol 119 patients with irritable bowel syndrome who will be included by about 50 general practitioners or gastroenterologists consulting in private offices. The treatment, Lactiplus® is a medical device, in the form of capsules containing L. gasseri LA806. The main objective of the study is to assess the effect of a 4-week treatment with the medical device on abdominal pain.
Detailed description
The study is designed as an observational post-market follow-up study, to confirm the performance of the medical device in real life conditions and document its safety profile.
The eligible population corresponds to the population that could benefit from the treatment, according to the MD's instructions for use. Non-inclusion criteria prevent from including patients with other pathologies associated with gastro-intestinal troubles, who may beneficiate from more adequate treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with irritable bowel syndrome
Key inclusion criteria (3 listed)
- Adult (age ≥ 18 years)
- Suffering from IBS (Rome IV criteria), whatever the predominant stool pattern, i.e recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: Related to defecation; Associated with a change in frequency of stool; Associated with a change in form (appearance) of stool; with symptom onset at least 6 months before diagnosis;
- Having access to electronic tools (computer, tablet…) and an internet connection, allowing him to complete the online self-questionnaire.
Key exclusion criteria (6 listed)
- Presence of clinical signs of alarm such as rectorrhagia, fever or recent unexpected weight loss or patient with suspicion or evidence of diseases that exclude IBS diagnosis: including but not limited to inflammatory gastrointestinal disease (e.g. Crohn's disease, ulcerative colitis), colorectal cancer, celiac disease, hyperthyroidism, intestinal infection, lactose intolerance, other malabsorption syndromes (e.g.: fructose), bile acid malabsorption;
- History of abdominal surgery except appendectomy;
- Allergy or hypersensitivity to one of the ingredients of the medical device;
- Inability to fill self-questionnaires or to understand the information notice (cognitive or linguistic issues);
- Participation to another clinical study or in the exclusion phase of a previous clinical study;
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 |
|---|---|---|
| Lactipluscapsules containing L. gasseri LA806 | Device | – |
Primary outcome
assess the effect of a 4-week treatment with the medical device on abdominal pain
Time frame: 4 weeks
6 secondary outcomes
assess the effect of a 4-week treatment with the medical device on digestive troubles
Time frame: 4 weeks
assess the effect of a 4-week treatment with the medical device on the patient's quality of life
Time frame: 4 weeks
assess the effect of a 4-week treatment with the medical device on the patient's intake of treatments (antidiarrheal, antispasmodic, laxative, pro/prebiotics, analgesics)
Time frame: 4 weeks
assess the tolerance of the medical device
Time frame: 4 weeks
assess the satisfaction with the medical device
Time frame: 4 weeks
assess the observance to the treatment and the intake of other medications
Time frame: 4 weeks
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 29 Sep 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 6 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 29 Sep 2020. 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?
assess the effect of a 4-week treatment with the medical device on abdominal pain (time frame: 4 weeks). 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 29 Sep 2020.