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Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen

RecruitingPhase 4

Sponsor: Indiana University

Conditions: Constipation

Interventions: PEG 3350, PEG-3350 with electrolytes, Glycerin

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 2 Years to 18 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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
* History of prior gastrointestinal surgery (excluding placement of G or GJ tubes)
* Underlying severe GI disease unrelated to the patient's chronic constipation
* Use within the past month of consent of probiotic supplements, prebiotic supplements or antibiotics

Locations (2)

Carmel, Indiana, United States
Indianapolis, Indiana, United States