Comparison Trial of Enema vs. PEG 3350 for Constipation (NCT00467350) | Clinical Trial Compass
TerminatedNot Applicable
Comparison Trial of Enema vs. PEG 3350 for Constipation
Stopped: concern patients in oral cleaout arm had worse outcome
United States80 participantsStarted 2006-12
Plain-language summary
The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated.
Who can participate
Age range
1 Year – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Number of Participants With Main Symptom Improvement