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NCT05576597
Effect of Butyrate Supplement on Rheumatoid Arthritis
Phase 2 trial testing Sodium Butyrate in Rheumatoid Arthritis in 30 participants. Completed in 15 June 2024.
1 October 2023
Quick facts
| Lead sponsor | Peking University People's Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 23 August 2022 |
| Primary completion | 1 October 2023 |
| Estimated completion | 15 June 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sodium Butyrate — full drug profile →
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
Sponsor
Peking University People's Hospital
Who can join
18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a pilot study to evaluate the safety and efficacy of administering butyrate supplement on rheumatoid arthritis patients. Thirty participants will be included to receive butyrate supplement for 12 weeks. Changes of immune cell subtypes, markers of intestinal damage, intestinal flora and other laboratory indicators will be monitored.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Enhancing Regulatory T Cells to Treat Inflammatory and Autoimmune Diseases.
Fiyouzi T, Pelaez-Prestel HF, Reyes-Manzanas R, Lafuente EM, et al · · 2023 · cited 27× · PMID 37175505 · DOI 10.3390/ijms24097797 -
The Potential of the Gut Microbiota and Butyrate to Enhance CAR T-cell Therapy in Non-Hodgkin Lymphoma.
García-Vicente R, Rodríguez-García A, Ancos-Pintado R, Arroyo A, et al · · 2026 · cited 1× · PMID 41231114 · DOI 10.1158/1078-0432.ccr-25-1676 -
Can we modulate the gut microbiome to enhance DMARD efficacy in rheumatoid arthritis?
Blank RB, Nayak RR, Scher JU. · · 2025 · PMID 39551674 · DOI 10.1016/j.semarthrit.2024.152583
Verify or expand the search:
- PubMed search for NCT05576597
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sodium Butyrate
Trials testing the same drug.
- NCT06700785 — A Pharmacokinetic Comparison of Three Butyrate Products · NA · completed
Other recruiting trials for Rheumatoid Arthritis
Currently open trials in the same condition.
- NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
- NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
Other Peking University People's Hospital trials
Trials by the same sponsor.
- NCT07535645 — Baricitinib for Post-HSCT Persistent Thrombocytopenia · Phase 1, PHASE2 · not yet recruiting
- NCT07516002 — Immunoglobulin Efficacy and Immune Profiling in Antibody Immunodeficiency · not yet recruiting
- NCT07294339 — A Randomized Controlled Trial of Acupuncture for the Management of Hot Flashes in Patients With Hormone Receptor-Positiv · NA · not yet recruiting
- NCT07500441 — Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML · recruiting
- NCT07487883 — Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors · recruiting
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 NCT05576597 (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 Peking University People's Hospital
- Last refreshed: 22 August 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/NCT05576597.
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