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Recruiting Phase 2 NCT05218850

NCT05218850 The Use of Butyrate Therapy in Pediatric Ulcerative Colitis

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Clinical Trial Summary
NCT ID NCT05218850
Status Recruiting
Phase Phase 2
Sponsor Children's Hospital Los Angeles
Condition Ulcerative Colitis
Study Type INTERVENTIONAL
Enrollment 10 participants
Start Date 2022-06-29
Primary Completion 2027-06-30

Eligibility & Interventions

Sex All sexes
Min Age 7 Years
Max Age 21 Years
Study Type INTERVENTIONAL
Interventions
Butyrate

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 10 participants in total. It began in 2022-06-29 with a primary completion date of 2027-06-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Butyrate is an important metabolite produced by the gut microbiome and has been shown as a helpful therapy in ulcerative colitis. This is a feasibility study to determine the efficacy of butryate enemas in pediatric ulcerative colitis.

Eligibility 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

Contact & Investigator

Central Contact

Sonia Michail, MD

✉ sonia.michail@hotmail.com

📞 3233611353

Principal Investigator

Sonia Michail, MD

PRINCIPAL INVESTIGATOR

Children's Hospital Los Angeles

Frequently Asked Questions

Who can join the NCT05218850 clinical trial?

This trial is open to participants of all sexes, aged 7 Years or older, up to 21 Years, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT05218850 trial and what does that mean for participants?

Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.

Is NCT05218850 currently recruiting?

Yes, NCT05218850 is actively recruiting participants. Contact the research team at sonia.michail@hotmail.com for enrollment information.

Where is the NCT05218850 trial being conducted?

This trial is being conducted at Los Angeles, United States.

Who is sponsoring the NCT05218850 clinical trial?

NCT05218850 is sponsored by Children's Hospital Los Angeles. The principal investigator is Sonia Michail, MD at Children's Hospital Los Angeles. The trial plans to enroll 10 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: July 2026  ·  Data Methodology