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

NCT04324658 | Completed

• 1 other identifier: PIL-DM-L.PLUS-019
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• assess the effect of a 4-week treatment with the medical device on abdominal pain

  4 weeks

Secondary Outcomes (6)

• assess the effect of a 4-week treatment with the medical device on digestive troubles

  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

Interventions

Lactiplus DEVICE

capsules containing L. gasseri LA806

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with irritable bowel syndrome

You may qualify if:

• 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.

You may not qualify if:

• 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);
• Refusal to participate.

Sponsors & Collaborators

• PiLeJe: lead

Study Sites (1)

General practitioners or gastroenterologists consulting in french private offices

Paris, France

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: July 30, 2019
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)