Enema Flush Regimen for Constipation
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will evaluate changes in the fecal microbiome in constipated pediatric patients before and after antegrade continence enema placement and initiation of antegrade enema flushes. Subjects will have their microbiome sequenced prior to placement by obtaining a fecal sample. Pre-antegrade continence enema placement results will be compared to fecal samples obtained at 0, 4, 8 months after placement of the antegrade continence enema and initiation of miralax or golytely flushes to look for changes in bacterial diversity.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot have used probiotic supplements, prebiotic supplements, or antibiotics in the month before joining.
Is the enema flush regimen using polyethylene glycol (PEG) 3350 safe for humans?
Polyethylene glycol 3350 (PEG 3350), used in products like MiraLAX and GoLYTELY, is generally considered safe for short-term use in treating constipation, with common side effects being nausea and abdominal cramps. However, there are rare cases of severe complications, such as electrolyte imbalances, especially if not prepared correctly, as seen in a pediatric case.12345
How does the enema flush regimen for constipation differ from other treatments?
The enema flush regimen is unique because it involves directly introducing a liquid into the rectum to relieve constipation, which is different from oral treatments like polyethylene glycol (PEG) 3350 that are taken by mouth. This method can provide more immediate relief compared to oral laxatives that need time to work through the digestive system.13467
What evidence supports the effectiveness of the drug for treating constipation?
Who Is on the Research Team?
Kate Hawa, DO
Principal Investigator
Riley Hospital for Children
Are You a Good Fit for This Trial?
This trial is for pediatric patients with severe, treatment-resistant constipation who will undergo a procedure called antegrade continence enema at Riley Hospital for Children. They should have normal colonic movement and not have had any GI surgery or used probiotics, prebiotics, or antibiotics in the last month.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-MACE Placement
Participants provide a stool sample before MACE placement while abstaining from osmotic laxative therapy for one week
Post-MACE Treatment
Participants undergo MACE placement and initiate daily antegrade enema flushes with PEG 3350 or PEG 3350 with electrolytes
Follow-up
Participants are monitored for changes in fecal microbiome diversity after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Glycerin
- PEG 3350
- PEG-3350 with electrolytes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor