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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT02358694
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients \> 8 years of age and \< 18 years of age
* Patients with a diagnosis of IBS-D as per Rome III criteria
* Patients with normal laboratory work up (CBC, ESR, CRP, amylase, lipase, celiac panel, fecal occult blood)
* Patients with normal fecal calprotectin and lactose hydrogen breath test
* Patients off motility drugs, NSAIDs for at least 2 weeks prior to enrollment in the study
* Ability to complete the study
* Patients on stable doses or other medications for at least 4 weeks prior to enrollment
Exclusion Criteria:
* Patients with h/o other GI, hepatic, renal, cardiovascular, neurologic or hematological disorder
* Patients with family history of inflammatory bowel disease
* Patients with history of abdominal surgery
* Patient with history of drug or alcohol abuse
* Patient with a history of allergy to study related products (e.g. beef)
* Use of probiotics in the previous month
* Patients who used SBI in the past
* Patients with soy allergy/sensitivity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT02358694
Study Brief:
Protocol Section:
NCT02358694