Using baclofen to treat children with rumination syndrome
A Randomized Controlled Pilot Trial of Baclofen for Children With Rumination Syndrome
This study is testing if the medication baclofen can help children aged 4 to 18 with rumination syndrome feel better by reducing their symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05975684 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of baclofen, a GABA-b agonist, in treating pediatric patients diagnosed with rumination syndrome, a condition characterized by the repetitive regurgitation of recently ingested food. Participants aged 4 to 18 will be randomly assigned to receive either baclofen or a placebo for four weeks, alongside their usual care. The study will assess symptom improvement through questionnaires completed at baseline and follow-up visits at weeks 1, 2, and 4. The research team will be blinded to the treatment assignments to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-18 who meet the Rome IV diagnostic criteria for rumination syndrome and are being treated at the Nationwide Children's Hospital GI clinic.
Not a fit: Patients with contraindications to baclofen, non-English speakers, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for children suffering from rumination syndrome.
How similar studies have performed: While baclofen has been used in other gastrointestinal disorders, this specific application for rumination syndrome is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children 4-18 years of age who meets Rome IV diagnostic criteria for rumination syndrome and are see at NCH GI clinic Exclusion Criteria: * Patients who have contraindications to baclofen due to medical history and/or current medications * Patients who are non- English speaking * Patients who are pregnant
Where this trial is running
Columbus, Ohio
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Peter Lu, MD, MS
- Email: peter.lu@nationwidechildrens.org
- Phone: 6147223450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.