Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
Recruiting
Phase 4
Interventional Study
Constipation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 2 – 18
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 65 (estimated)
- Sponsor
- Indiana University · Other
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About 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 pl…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Recalcitrant chronic functional constipation necessitating a MACE appendicostomy or cecostomy for treatment at Riley Hospital for Children
* Intact colonic motility as evidenced by CMS studies
Exclusion Criteria
* Underlying anatomic or pathologic etiology for constipation
*…
Contacts