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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and 8 months post-mace
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and 8 months post-mace
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Fecal Microbiome at 1 month
Change in Fecal Microbiome at 4 months
Change in Fecal Microbiome at 8 months
Secondary outcome measures
Effect of Bowel Regimen Solution on Fecal Bacterial Diversity
Effect of Glycerin on Fecal Microbiome Diversity
Effect of Redundant Sigmoid Colon on Microbiome Diversity
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
PEG 3350
2013
Completed Phase 4
~20
Glycerin
2017
N/A
~10
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
981,712 Total Patients Enrolled
3 Trials studying Constipation
5,383 Patients Enrolled for Constipation
Kate Hawa, DOPrincipal InvestigatorRiley Hospital for Children
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a severe stomach or intestine disease not caused by my chronic constipation.I need a special procedure for my severe constipation not responding to other treatments.I have used probiotics, prebiotics, or antibiotics in the last month.I have a physical reason for my constipation.I have had surgery on my digestive system before.My bowel movements are normal according to tests.
Research Study Groups:
This trial has the following groups:- Group 1: PEG 3350
- Group 2: PEG 3350 with electrolytes
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks should be considered when utilizing PEG 3350 for medical treatment?
"The safety of PEG 3350 is deemed safe enough to have already received approval, earning it a score of 3."
Answered by AI
Do I qualify to take part in this research endeavor?
"Eligible applicants must be aged between 2 and 21, with a primary complaint of constipation. The current recruitment goal is 50 participants."
Answered by AI
Is this research open to individuals aged 85 and over?
"To be considered for this trial, applicants must have an age from 2 to 21. This research is recruiting 28 patients under the age of 18 and 61 individuals aged 65 or above."
Answered by AI
Is this experiment still in a position to accept participants?
"According to clinicaltrials.gov, this trial is not presently accepting new patients; the study was initially published on April 1st 2023 and amended most recently on April 7th 2023. Despite this, there are 90 other medical studies actively enrolling participants at present."
Answered by AI
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