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Enema Flush Regimen for Constipation

Phase 4
Recruiting
Led By Kate Hawa, DO
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and 8 months post-mace
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will analyze changes in gut bacteria in constipated children before and after a type of enema and enema flushes. Bacteria will be studied using fecal samples.

Who is the study for?
This trial is for pediatric patients with severe, treatment-resistant constipation who will undergo a procedure called antegrade continence enema at Riley Hospital for Children. They should have normal colonic movement and not have had any GI surgery or used probiotics, prebiotics, or antibiotics in the last month.
What is being tested?
The study looks at how the fecal microbiome (the community of bacteria in poop) changes after kids start using bowel flushes with PEG 3350 or Golytely following an antegrade continence enema placement. Their poop is tested before and then several times up to 8 months after starting treatment.
What are the potential side effects?
Possible side effects from bowel flushes include abdominal pain, bloating, nausea, diarrhea, and possible allergic reactions to ingredients in PEG solutions like electrolytes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and 8 months post-mace
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and 8 months post-mace for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Fecal Microbiome at 1 month
Change in Fecal Microbiome at 4 months
Change in Fecal Microbiome at 8 months
Secondary study objectives
Effect of Bowel Regimen Solution on Fecal Bacterial Diversity
Effect of Glycerin on Fecal Microbiome Diversity
Effect of Redundant Sigmoid Colon on Microbiome Diversity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Group I: PEG 3350 with electrolytesExperimental Treatment2 Interventions
Patients will receive PEG 3350 with electrolytes (Go-Lytely or generic equivalent) for their MACE flushes.
Group II: PEG 3350Experimental Treatment2 Interventions
Patients will receive PEG 3350 (miralax or generic equivalent) for their MACE flushes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glycerin
2017
N/A
~10
PEG 3350
2013
Completed Phase 4
~20

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,039 Previous Clinical Trials
1,218,993 Total Patients Enrolled
3 Trials studying Constipation
5,139 Patients Enrolled for Constipation
Kate Hawa, DOPrincipal InvestigatorRiley Hospital for Children

Media Library

PEG 3350 Clinical Trial Eligibility Overview. Trial Name: NCT05821309 — Phase 4
Constipation Research Study Groups: PEG 3350, PEG 3350 with electrolytes
Constipation Clinical Trial 2023: PEG 3350 Highlights & Side Effects. Trial Name: NCT05821309 — Phase 4
PEG 3350 2023 Treatment Timeline for Medical Study. Trial Name: NCT05821309 — Phase 4
~19 spots leftby Jul 2025
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