Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT00331994
Eligibility Criteria:
Inclusion criteria:
* Irritable bowel syndrome patients with small intestinal bacterial overgrowth (based on positive lactulose or glucose hydrogen breath test)
* Patients able to maintain their usual diet and lifestyle during the course of the study.
Exclusion criteria:
* Pregnancy or breast-feeding
* Major concomitant diseases (including tumours and hepatic and/or renal insufficiency)
* Inflammatory bowel diseases
* History of intestinal surgery (except cholecystectomy and appendectomy)
* Use of antibiotic, laxative, antidiarrheic drugs or probiotics (medications or dietetic supplements) in the last month prior to study entry
* Hypersensibility to the investigational product and reference drug
* Clinical evidence of relevant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, neurologic or of any disease that may interfere with the patient successfully completing the trial or the objectives of the trial
* Eating disorders such as anorexia or bulimia, and/or psychosis, schizophrenia, mania or major psychiatric illness needing pharmacological treatment. Well-compensated depression does not exclude a potential patient
* Participation to a trial in the previous three months
* Drug or alcohol abuse
* Subjects with unstable personality or not able to be compliant with the study procedures
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00331994
Study Brief:
Protocol Section:
NCT00331994