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

Description

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

Constipation

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Constipation
Intervention / Treatment

-

Contacts and Locations

Carmel

IU North Hospital, Carmel, Indiana, United States, 46032

Indianapolis

Riley Hospital for Children, Indianapolis, Indiana, United States, 46224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

2 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Indiana University,

Kate Hawa, DO, PRINCIPAL_INVESTIGATOR, Riley Hospital for Children

Study Record Dates

2025-07