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 @ 4:19 AM
Ignite Modification Date:
2025-12-25 @ 4:19 AM
NCT ID:
NCT02016820
Eligibility Criteria:
Inclusion Criteria:
* Zero to 4 years old
* Being considered for PPI or H2RA treatment for refractory GERD
* Parent is able to give informed consent
Exclusion Criteria:
* Prevalent C. difficile infection (excluded via stool PCR at week 0)
* Use of systemic antibiotics within the past 90 days
* Use of acid suppression medications within the past 90 days (antacids allowed if none within the last 7 days)
* Increased risk for fracture due to vitamin D deficiency or other causes
* Chronic gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, microscopic colitis, malabsorptive conditions, short gut syndrome)
* Congenital deficiency in immunity (e.g., such as IgA deficiency)
* Cystic fibrosis
* Significant dynamic or uncontrolled comorbidity such as HIV or malignancy
* Use of medications with potential interaction with PPIs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
4 Years
Study:
NCT02016820
Study Brief:
Protocol Section:
NCT02016820