Effect and Tolerance of a Probiotic-based Medical Device Administered to Patients With Irritable Bowel Syndrome

NCT ID: NCT04324658

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-30
• Study Completion Date: 2020-06-26

Brief 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. 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.

Conditions

Irritable Bowel Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Lactiplus

capsules containing L. gasseri LA806

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PiLeJe

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

General practitioners or gastroenterologists consulting in french private offices

Paris, , France

Countries

France

Other Identifiers

PIL-DM-L.PLUS-019

Identifier Type: -

Identifier Source: org_study_id