Using domperidone to help young people with severe stomach issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This program allows children aged 12 to 21 with refractory gastroparesis and GERD symptoms to receive domperidone after failing standard treatments. Participants will undergo a thorough medical evaluation, including physical exams and ECGs, to ensure safety before starting the medication. Domperidone will be administered four times daily, with regular follow-ups to monitor health and medication effects. The study aims to provide a potential solution for those suffering from severe gastrointestinal motility disorders.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female
2. Age 12 - 21
3. Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.
4. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
5. Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

   * increased prolactin levels
   * extrapyramidal side effects
   * breast changes
   * Cardiac arrhythmias including QT prolongation
   * There is a potential for increased risk of adverse events with the drugs and herbal supplements listed in the addendum (See Addendum on pages 24 and 25)
   * The coordinator/investigator will have a discussion with the family about the use of any of the medications and herbal supplements listed in the addendum to make sure they understand the increased risk of their use and the need to contact the investigators prior to using any of the listed medications and herbal supplements.

Exclusion Criteria:

1. History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
2. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged Tc (QTc\> 450 milliseconds for males, QTc\>470 milliseconds for females).
3. Clinically significant electrolyte disorders.
4. Gastrointestinal hemorrhage or obstruction
5. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
6. Pregnant or breast feeding female
7. Known allergy to domperidone

Where it's running

• Children's Mercy Hospitals and Clinics
  Kansas City, Missouri, United States Recruiting

Study contacts

• Principal investigator: Jose Cocjin, MD — Children's Mercy Hospital Kansas City
• Study coordinator: Corey Schurman, MA, CCRC
• Email: crschurman@cmh.edu
• Phone: 816-302-3076

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Thread-Embedding Acupuncture plus a Proton Pump Inhibitor for GERD

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• Virtual poetry workshops to boost well-being for people with digestive symptoms

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• Transoral incisionless fundoplication (TIF) for GERD in Asian adults

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  Recruiting Phase 2 Chinese University of Hong Kong · Hong Kong · NCT07556289

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.