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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Device: Lactiplus

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 Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• France
  • Paris, France
    • General practitioners or gastroenterologists consulting in french private offices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with irritable bowel syndrome

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
assess the effect of a 4-week treatment with the medical device on abdominal pain	4 weeks

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: PiLeJe

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): June 26, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: PIL-DM-L.PLUS-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No