Effect and Tolerance of a Probiotic-based Medical Device Administered to Patients With Irritable Bowel Syndrome (Lactiplus)
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|ClinicalTrials.gov Identifier: NCT04324658|
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : March 27, 2020
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.
|Condition or disease||Intervention/treatment|
|Irritable Bowel Syndrome||Device: Lactiplus|
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 Type :||Observational|
|Estimated Enrollment :||119 participants|
|Official Title:||Effect and Tolerance of a Probiotic-based Medical Device (Lactiplus®) Administered to Patients With Irritable Bowel Syndrome|
|Actual Study Start Date :||July 30, 2019|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
- Device: Lactiplus
capsules containing L. gasseri LA806
- assess the effect of a 4-week treatment with the medical device on abdominal pain [ Time Frame: 4 weeks ]
- assess the effect of a 4-week treatment with the medical device on digestive troubles [ Time Frame: 4 weeks ]global symptom score, intestinal symptoms (discomfort, distension/bloating, urgency to defecate, bowel habit, incomplete rectal emptying), Francis score, Clinical global impression of improvement
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04324658
|Contact: Samira Ait Abdellah||(0)1 45 51 78 email@example.com|
|General practitioners or gastroenterologists consulting in french private offices||Recruiting|