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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT00467350
Eligibility Criteria:
Inclusion Criteria:
* Constipated children who have one of the following three conditions:
* Fecal impaction (lower quadrant mass or dilated rectum with hard stool),
* Functional fecal retention (large diameter stools as determined by caregiver \<twice/week and retentive behaviors, or
* Excessive stool in colon on abdominal radiograph as determined by attending radiologist or treating physician
Exclusion Criteria:
* Ill appearing patients (signs of acute surgical abdomen, abnormal vital signs, or overall ill appearing as determined by treating physician)
* Patients whose evaluation in the ED includes more than plain radiographs or urinalysis
* Patients who receive analgesia for the abdominal pain in the ED (except acetaminophen or ibuprofen)
* Non-English speaking patients and families
* Patients with milk allergy
* Patients with molasses allergy
* Patients who are pregnant
* Patients with a chronic medical conditions which may be associated with constipation (including patients with cystic fibrosis, cerebral palsy, hypothyroidism, spinal anomalies, and known gastrointestinal anatomic abnormalities) or a history of prior abdominal or rectal surgery
* Patients who are admitted to an in-patient unit
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
17 Years
Study:
NCT00467350
Study Brief:
Protocol Section:
NCT00467350