Status:
COMPLETED
Effect and Tolerance of a Probiotic-based Medical Device Administered to Patients With Irritable Bowel Syndrome
Lead Sponsor:
PiLeJe
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
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 pract...
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 populatio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 26 2020
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT04324658
Start Date
July 30 2019
End Date
June 26 2020
Last Update
September 29 2020
Active Locations (1)
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1
General practitioners or gastroenterologists consulting in french private offices
Paris, France