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NCT05218850
The Use of Butyrate Therapy in Pediatric Ulcerative Colitis
Phase 1 trial testing Butyrate in Ulcerative Colitis in 10 participants. Currently enrolling.
30 June 2027
Quick facts
| Lead sponsor | Children's Hospital Los Angeles |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 29 June 2022 |
| Primary completion | 30 June 2027 |
| Estimated completion | 30 June 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Butyrate — full drug profile →
Conditions studied
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
Sponsor
Children's Hospital Los Angeles
Who can join
Adults 7 to 21, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Intestinal Dysbiosis: Microbial Imbalance Impacts on Colorectal Cancer Initiation, Progression and Disease Mitigation.
Garvey M. · · 2024 · cited 24× · PMID 38672096 · DOI 10.3390/biomedicines12040740 -
Microbiota-derived metabolites in inflammatory bowel disease.
Guggeis MA, Harris DM, Welz L, Rosenstiel P, et al · · 2025 · cited 10× · PMID 40032666 · DOI 10.1007/s00281-025-01046-9 -
Harnessing nature's pharmacy: investigating natural compounds as novel therapeutics for ulcerative colitis.
Huang Y, Wu Q, Li S, Lin X, et al · · 2024 · cited 6× · PMID 39206263 · DOI 10.3389/fphar.2024.1394124
Verify or expand the search:
- PubMed search for NCT05218850
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Butyrate
Trials testing the same drug.
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- NCT05718583 — Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders · NA · completed
- NCT04722549 — Effects of Butyrate on Affective Processes · NA · completed
- NCT04879914 — Analysis of Microbiota Changes Induced by Microencapsulated Sodium Butyrate in Patients With Inflammatory Bowel Disease · NA · completed
Other recruiting trials for Ulcerative Colitis
Currently open trials in the same condition.
- NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
- NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
- NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
- NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
- NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting
Other Children's Hospital Los Angeles trials
Trials by the same sponsor.
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- NCT07508436 — Crisis Interventions for Pediatric Providers - Autism Version · NA · not yet recruiting
- NCT06934655 — Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth · Phase 3 · not yet recruiting
- NCT07427862 — Virtual Reality (VR) for Interventional Radiology (IR) Procedures · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05218850 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital Los Angeles
- Last refreshed: 18 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05218850.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing