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 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT01532518
Eligibility Criteria:
Inclusion Criteria:
* Infants with a clinical diagnosis of feeding intolerance.
* Age ≤ 6 months at the enrolment.
* Normal growth.
* Infants who can refrain from use of erythromycin, metoclopramide, antihistaminic drug, proton pump inhibitors (PPIs), antacids, antimuscarinic drugs, simethicone and dimethicone from 1 week prior randomization until end of study.
Exclusion Criteria:
* Any clinically relevant event (excluding those relevant to the condition under study) which has occurred within one week prior to randomization.
* Any pharmacological treatment starting within one week prior to randomization.
* Infants for whom a change in the diet (i.e. weaning) has been performed within one week prior to randomization or is planned during the study period.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Months
Study:
NCT01532518
Study Brief:
Protocol Section:
NCT01532518