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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT01887834
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects aged 18-64.
* A diagnosis of Irritable Bowel Syndrome as per ROME III criteria.
* A classification of severe irritable bowel syndrome as indicated by the Irritable Bowel Severity Scoring System (score \>300).
* Female subjects currently using an acceptable form of birth control who agree to maintain its use throughout the study (e.g. abstinence, oral contraceptives, barrier methods).
* Subjects who agree to maintain their current eating habits throughout the study.
* Ability to understand and sign the Informed Consent Form.
Exclusion Criteria:
* Female subjects who are breastfeeding, pregnant, or are open to becoming pregnant in the next three months
* Subjects currently receiving medication for the treatment of IBS symptoms.
* Subjects currently receiving natural health products for treatment of IBS symptoms will be eligible for inclusion in the trial is they agree to undergo a four week washout period.
* Subjects currently experiencing nausea, fever, vomiting, bloody diarrhea or severe abdominal pain.
* Subjects who are immune-compromised (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment).
* Subjects currently receiving antibiotic therapy or antibiotic therapy within the previous month.
* Subjects regularly (\>3 times weekly) consuming probiotics enriched products (e.g. probiotic enriched yogurts, Activia, etc…).
* Subjects who have recently (\< 3 months) initiated dietary measures to control IBS symptoms, such as elimination of certain foods.
* Subjects with a history of major or complicated gastrointestinal surgery.
* Subjects with severe endometriosis.
* Subjects with malignant tumors or subjects undergoing chemotherapy or radiation therapy.
* Subjects with severe IBS that require medication for treatment of IBS symptoms.
* Subjects with weight loss, anemia, inflammatory bowel disease, or celiac sprue, and family history of colorectal cancer.
* Subjects exhibiting or indicating thoughts of suicide currently or in the past as based on patient screening interview by the investigator/clinician. Appropriate referral to a health care provider will be provided.
* Subjects with known allergies to milk or milk based products.
* Subjects using and/or have used antipsychotic or anticholinergic medication within the prior month, those with reported significant abnormalities on thyroid function tests, blood counts and serum chemistry.
* Subjects 50 years or older who have been diagnosed with IBS and have not received a colonoscopy in the last five years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01887834
Study Brief:
Protocol Section:
NCT01887834