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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT01914003
Eligibility Criteria:
Inclusion Criteria:
* Must be 18 years of age or younger.
* A primary clinical diagnosis of chronic idiopathic diarrhea or chronic abdominal pain for at least 4 weeks.
* English or Spanish speaking subjects and parent(s)/guardian only.
* Parental consent from one parent/guardian and also subject assent when appropriate based on individual IRB requirements.
Exclusion Criteria:
* Any condition(s) or finding(s) that in the opinion of the principal investigator suggests an alternative diagnosis for his/her gastrointestinal symptoms.
* Abdominal pain primarily related to constipation.
* Suspected gastrointestinal infectious disease.
* No current use of sacrosidase (Sucraid® Oral Solution).
* Known gastrointestinal disease such as celiac disease.
* Prior consumption of an investigational medication within the last 4 weeks.
* Antibiotics in the last 2 weeks, and no history of viral gastroenteritis within that same period of time.
* Known Hepatitis B or C infection (positive HBsAg or HCV within 6 months of enrollment) or Subject-Pugh Class C liver disease of any cause, HIV infection, tuberculosis, Clostridia difficile co-infection, cancer or systemic infections.
* Severe neurologic impairment that would prevent them from reporting a history of abdominal pain.
* Receiving or received biologic therapies (including infliximab, adalimumab, natalizumab) within 3 months prior to or at enrollment.
* Present or past use of immune modulators therapy (e.g., azathioprine, 6MP, methotrexate).
* Planned or previous abdominal surgery (e.g., bowel resection).
* Subjects with severe, uncontrolled systemic diseases.
* Presence of clinical alarm signs, including hypotension, anemia requiring blood transfusions, altered mental status, or inability to tolerate food and/or fluids by mouth.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT01914003
Study Brief:
Protocol Section:
NCT01914003