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:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT00618904
Eligibility Criteria:
Inclusion Criteria:
* The subject is 18 to 75 years old.
* The subject is an ambulatory outpatient.
* The subject has IBS, or functional diarrhea, or functional bloating according to the Rome II criteria for functional GI disorders.
* The subject has the above symptoms for at least two weeks, despite current therapy. For diarrhea, we will use the definition of a mean of \>2 bowel movements per day, or a mean score of \> 4 on the Bristol Stool Form Scale per week. For bloating we will use the Rome II definition "a feeling of abdominal fullness or bloating".
* Subject must have had a colonoscopy if age \> 50y/o.
* The subject's symptoms are mild to moderate symptoms in severity. Symptoms severity will be assessed at baseline and at the end of the 2-weeks screening period to determine eligibility prior randomization. Severity of bowel symptoms will be determined using the Francis Whorwell IBS severity scale: Mild \<175, Moderate 175-300, Severe \>300
Exclusion Criteria:
* The subject has inflammation or structural abnormality of the digestive tract (e.g. inflammatory bowel disease (IBD), duodenal ulcer (DU) or gastric ulcer (GU), obstruction, symptomatic cholelithiasis).
* The subject has severe FBD related symptoms at baseline.
* The subject has a serious, unstable medical condition.
* The subject has insulin-dependent Diabetes Mellitus.
* The subject had a major psychiatric diagnosis or a suicide attempt within the last two years.
* The subject has a history of alcohol or substance abuse within two years.
* The subject has abnormal laboratory results (including ALT or AST \> than 2.5 times normal, serum creatinine \>2.0mg/dl, untreated abnormal TSH value)
* The subject has been treated for a malignancy within the last 5 years (except BCC or SCC skin cancer).
* The subject has been diagnosed with lactase deficiency and this can explain their symptoms (i.e., symptoms resolved or reduced significantly with lactose-free diet.)
* The subject has participated in a drug study within the last 21 days.
* The subject received antibiotic treatment during the last 8 weeks. (If the subject was on antibiotic treatment, a washout period of 8 weeks is required).
* The subject had previous significant intestinal surgery.
* The subject is pregnant or lactating, or unwilling to maintain effective contraception during course of study
* The subject is predisposed to infection (i.e. their immune system is compromised, they have rheumatic heart disease, an artificial valve, history of bacterial endocarditis, or an active bacterial disease)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00618904
Study Brief:
Protocol Section:
NCT00618904