Actively Recruiting
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
Led by Indiana University · Updated on 2025-07-04
65
Participants Needed
2
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 18 years
- Recalcitrant chronic functional constipation requiring MACE appendicostomy or cecostomy treatment at Riley Hospital for Children
- Intact colonic motility confirmed by colonic manometry studies
You will not qualify if you...
- Underlying anatomic or pathologic cause for constipation
- History of prior gastrointestinal surgery except gastrostomy or gastrojejunostomy tube placement
- Severe gastrointestinal disease unrelated to chronic constipation
- Use of probiotic supplements, prebiotic supplements, or antibiotics within one month before consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
IU North Hospital
Carmel, Indiana, United States, 46032
Actively Recruiting
2
Riley Hospital for Children
Indianapolis, Indiana, United States, 46224
Actively Recruiting
Research Team
E
Erik Andrewski, MD
CONTACT
A
Ann Klipsch, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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