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

ConditionConstipation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-18
SponsorIndiana University

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 placement of the antegrade continence enema and initiation of miralax or golytely flushes to look for changes in bacterial diversity.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • PEG 3350

    Drug

    The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing. PEG 3350 will be compared to PEG 3350 with electrolytes

  • PEG-3350 with electrolytes

    Drug

    The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing. PEG 3350 will be compared to PEG 3350 with electrolytes

  • Glycerin

    Drug

    Glycerin will be given to patients based on standard of care, at the discretion of the pediatric gastroenterology and pediatric surgery teams. Glycerin administration will not be randomized. For secondary analysis, the microbiomes of those who have and have not received glycerin will be compared.

Treatment groups

65 Participants
are divided into 2 treatment groups
Group A: PEG 3350Experimental treatment 2 interventions
Group B: PEG 3350 with electrolytesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Fecal Microbiome at 1 month

The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing

Time frame
At baseline and 1 month post-MACE
2

Change in Fecal Microbiome at 4 months

The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing

Time frame
At baseline and 4 months post-MACE
3

Change in Fecal Microbiome at 8 months

The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing

Time frame
At baseline and 8 months post-MACE

Secondary outcomes

1

Effect of Bowel Regimen Solution on Fecal Bacterial Diversity

Determine whether a difference in fecal bacterial diversity determined by 16s rRNA sequencing exists between differing MACE bowel regimens of 1. Bisacodyl and PEG 3350 in electrolyte solution (GoLytely) or 2. Bisacodyl and PEG 3350 without electrolytes (Miralax).

Time frame
Through study completion, approximately 8 months
2

Effect of Glycerin on Fecal Microbiome Diversity

Determine whether patients receiving glycerin in addition to PEG 3350 with or without electrolytes display differences in their fecal microbiota as measured by 16s rRNA sequencing.

Time frame
Through study completion, approximately 8 months
3

Effect of Redundant Sigmoid Colon on Microbiome Diversity

Evaluate for differences in the fecal microbiome determined by 16s rRNA sequencing between those patients who have a redundant sigmoid colon based on barium enema results and those who do not

Time frame
Through study completion, approximately 8 months

Other outcomes

Sponsors and contacts

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