New drink could make colonoscopy prep easier for young children
NCT ID NCT04113382
First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 5 times
Summary
This study compares two bowel-cleansing drinks in 30 children aged 2 to 8 who need a colonoscopy. One group gets CLENPIQ, a ready-to-drink solution, and the other gets MIRALAX, a powder mixed with water. The goal is to see which one cleans the colon better and is safer for kids.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CLENPIQ (sodium picosulfate, magnesium oxide, citric acid) and MIRALAX (polyethylene glycol 3350)
- What this could lead to
- If it works, this could provide a more convenient, pre-mixed bowel prep option for young children needing a colonoscopy.
- What could go wrong
- This is an early-phase trial with only 30 children, so results may not apply to all kids. Both drugs can cause side effects like nausea or dehydration.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 months to 8 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female, aged 12 months to \<9 years being scheduled to undergo elective colonoscopy. * Weight ≥10 kg (≥22 lbs). * Participants must have had regular spontaneous bowel movements (SBM) weekly for 1 month prior to the colonoscopy. * Written informed consent (by parent(s)/ caregiver(s)/ guardian(s)) and assent (if applicable) obtained at screening. Exclusion Criteria: * History of significant liver, cardiovascular, or renal disease (including recent or ongoing oliguria). * Acute surgical abdominal conditions (e.g., acute obstruction or perforation) during the screening period. * Concern for obstipation or fecal impaction. * Severe acute inflammatory bowel disease (IBD) defined as subjects with a Pediatric Ulcerative Colitis Activity Index (PUCAI) score \>65 or a Short Pediatric Crohn's Disease Activity Index (short PCDAI) score \>40, at the time of screening, or development of severe IBD between (Visit 1) and investigational medicinal product (IMP) dispensation (Visit 2). * Any prior colorectal surgery, excluding appendectomy and polyp removal. * History of colon disease (e.g., Hirschsprung disease, volvulus, idiopathic pseudo-obstruction, or hypomotility syndrome). * History of or ongoing intestinal ulceration, toxic megacolon or other toxic colitis. * History of upper gastrointestinal disorder (e.g., active ulcer, pyloric stenosis or other cause of gastric retention, gastroparesis, or ileus). * History of upper gastrointestinal surgery (e.g., gastric resection or gastric bypass), excluding cholecystectomy. * Chronic or persistent, severe nausea or vomiting during the screening period. * Moderate to severe dehydration during the screening period. * Prior history of epileptic reaction, convulsions, or seizures. * Any clinically relevant neurological events with or without association with hyponatremia during the screening period. * Serum creatinine, estimated glomerular filtration rate (eGFR), potassium, or sodium outside normal limits during the screening period. * Hypermagnesemia during the screening period. * Use of the following prohibited medication: lithium (within 48 hours prior to procedure), laxatives (within 24 hours prior to procedure), drugs that in the opinion of the investigator are causing constipation in the participant (within 48 hours prior to procedure), antidiarrheal drugs (within 72 hours prior to procedure), or oral iron preparations (within 1 week prior to procedure). * Participation in an interventional investigational trial requiring administration of an investigational drug within 30 days prior to receiving trial medication (or within 60 days for investigational drugs with an elimination half-life \>15 days). * Any clinically relevant abnormal findings in medical history, physical examination, vital signs, electrocardiogram (ECG), clinical chemistry, hematology, coagulation, or urinalysis at screening which in the opinion of the investigator(s), might put the participant at risk because of his/her participation in the trial. * Hypersensitivity to any of the ingredients of the trial medications. * Inability to comply with the dietary restrictions in the trial or the fluid requirements before and after investigational medicinal product (IMP) administration.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins Children's Medical Center
RECRUITINGBaltimore, Maryland, 21287, United States
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Rady Children's Hospital (San Diego)
RECRUITINGSan Diego, California, 92123, United States
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South Alabama Medical Science Foundation
RECRUITINGMobile, Alabama, 36604, United States
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University of Maryland, Baltimore
RECRUITINGBaltimore, Maryland, 21201, United States
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