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New treatment option for Constipation
Official title Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
ClinicalTrials.gov ID: NCT05821309
What this study is testing
What is PEG 3350?
PEG 3350 is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for constipation.
Also referred to as MiraLAX or generic equivalent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Carmel, Indiana, United States
- Indianapolis, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 18 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Carmel, Indiana, United States; Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.