Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactiplus | Device | capsules containing L. gasseri LA806 |
| Measure | Description | Time Frame |
|---|---|---|
| assess the effect of a 4-week treatment with the medical device on abdominal pain | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| assess the effect of a 4-week treatment with the medical device on the patient's quality of life |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
patients with irritable bowel syndrome
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General practitioners or gastroenterologists consulting in french private offices | Paris | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) | 4 weeks |
| assess the tolerance of the medical device | 4 weeks |
| assess the satisfaction with the medical device | 4 weeks |
| assess the observance to the treatment and the intake of other medications | 4 weeks |
| D004066 | Digestive System Diseases |