Butyrate therapy for children with ulcerative colitis
Butyrate Therapy in Hispanic Children With Ulcerative Colitis
This study is testing whether butyrate enemas can help children aged 7 to 21 with mild to moderate ulcerative colitis feel better while they continue their usual treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 7 Years to 21 Years |
| Sex | All |
| Sponsor | Children's Hospital Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05218850 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of butyrate enemas as a treatment for pediatric patients aged 7 to 21 with mild to moderate ulcerative colitis. Over a 12-week period, participants will receive butyrate therapy while continuing standard management practices, including routine laboratory studies and endoscopy. The primary goal is to assess the efficacy of butyrate in improving clinical outcomes for these children.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 21 diagnosed with mild to moderate ulcerative colitis.
Not a fit: Patients currently undergoing other ulcerative colitis therapies or those with infectious colitis or pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel and effective treatment option for children suffering from ulcerative colitis.
How similar studies have performed: While the use of butyrate in ulcerative colitis has shown promise, this specific approach in pediatric patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 7-21 years, mild to moderate ulcerative colitis Exclusion Criteria: * UC therapy within 4 weeks of study medication initiation * infectious colitis, -pregnancy
Where this trial is running
Los Angeles, California
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Sonia Michail, MD — Children's Hospital Los Angeles
- Study coordinator: Sonia Michail, MD
- Email: sonia.michail@hotmail.com
- Phone: 3233611353
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.