Lactibiane Tolérance® in Individuals Suffering From Irritable Bowel Syndrome With Diarrheal Predominance (PILATE)

This is an interventional treatment trial for Diarrhea Predominant Irritable Bowel Syndrome Read More

Inclusion Criteria:

• Age from 18 to 75;
• With symptoms of IBS with predominant diarrhea according to the Rome III criteria;
• For women of childbearing age: effective contraception and agreement to keep it throughout the study;
• General and mental health compatible with participation in the study and to be followed as an outpatient in the opinion of the investigator: no clinically significant and relevant abnormality according to medical history and physical examination;
• Agreeing to maintain their lifestyle during the study (same eating habits and physical activity);
• Able and willing to participate in research in accordance with the protocol procedures particularly regarding consumption of the product under consideration and having signed an informed consent form dated;
• Belonging to a social security scheme;
• Willing to be included in the file of volunteers participating in biomedical research.

Exclusion Criteria:

• Having a history of hypersensitivity to any of the ingredients of the product under consideration;
• Having a history of hypersensitivity to fluorescein and / or red carmine (E120 food coloring);
• With immunodeficiency or with a severe or progressive disease (cardiac, pulmonary, hepatic, renal, hematologic, neoplastic, or infectious);
• With acute or severe chronic disease (chronic alcoholism, drug addiction) found incompatible with participation in the study by the investigator;
• Suffering from a metabolic disorder or a chronic inflammatory digestive disease affecting the intestinal transit or absorption of nutrients such as diabetes, hyperthyroidism, celiac disease or Crohn's disease;
• Having a medical history or current condition that, according to the investigator, may interfere with the results of the study or expose the subject to additional risk;
• Currently under medication or food supplement treatment, according to the investigator, may interfere with the results of the study or stopped within too short before inclusion in V1 (less than a month for antibiotics, pre and probiotics, less than 14 days for antidiarrheal, steroidal anti-inflammatories, NSAIDs, aspirin, antihistamines and drugs. treatment with maximum 2 concomitant psychotropic can be tolerated only if it exists for more than 3 months before inclusion);
• Having a lifestyle incompatible with the study by the investigator;
• Woman during pregnancy or breastfeeding or planning to become pregnant within 2 months;
• Planning to travel and hold during the study period or impossible to contact in case of emergency;
• Having a psychological or linguistic inability to understand and sign the informed consent;
• Participating in another clinical trial or exclusion period of a previous clinical trial;
• Having received over the past 12 months, no more than 4,500 euros in payment for participation in clinical trials;
• Under legal protection (guardianship, trusteeship) or deprived of his rights under the administrative or judicial decision.