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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04324658
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Pileje

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.


Condition or disease Intervention/treatment
Irritable Bowel Syndrome 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.

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Study Type : Observational
Estimated Enrollment : 119 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • Device: Lactiplus
    capsules containing L. gasseri LA806


Primary Outcome Measures :
  1. assess the effect of a 4-week treatment with the medical device on abdominal pain [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. 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

  2. assess the effect of a 4-week treatment with the medical device on the patient's quality of life [ Time Frame: 4 weeks ]
  3. 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 ]
  4. assess the tolerance of the medical device [ Time Frame: 4 weeks ]
  5. assess the satisfaction with the medical device [ Time Frame: 4 weeks ]
  6. assess the observance to the treatment and the intake of other medications [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with irritable bowel syndrome
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Samira Ait Abdellah (0)1 45 51 78 77 s.aitabdellah@pileje.com

Locations
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France
General practitioners or gastroenterologists consulting in french private offices Recruiting
Paris, France
Sponsors and Collaborators
Pileje

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Responsible Party: Pileje
ClinicalTrials.gov Identifier: NCT04324658    
Other Study ID Numbers: PIL-DM-L.PLUS-019
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases