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NCT03521297
Probiotics in PBC Patients of Poor Response to UDCA
Status unknown
Phase 2
Last updated 7 January 2020
What this trial tests
Phase 2 trial testing Probiotic in Primary Biliary Cholangitis (PBC) in 60 participants. Status unknown.
Timeline
20 January 2020
Primary endpoint
31 January 2021
31 January 2021
31 August 2021
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 20 January 2020 |
| Primary completion | 31 January 2021 |
| Estimated completion | 31 August 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Probiotic
- Placebo
Conditions studied
- Primary Biliary Cholangitis (PBC) — all drugs for Primary Biliary Cholangitis (PBC) →
Sponsor
Sun Yat-sen University
Who can join
Adults 18 to 70, any sex, with Primary Biliary Cholangitis (PBC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The safety and efficacy of probiotics in primary biliary cholangitis (PBC) patients with poor ursodeoxycholic acid (UDCA) response.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Gut-Liver Axis in Cholestatic Liver Diseases.
Blesl A, Stadlbauer V. · · 2021 · cited 58× · PMID 33801133 · DOI 10.3390/nu13031018 -
Primary Biliary Cholangitis and Primary Sclerosing Cholangitis: Current Knowledge of Pathogenesis and Therapeutics.
Park JW, Kim JH, Kim SE, Jung JH, et al · · 2022 · cited 41× · PMID 35740310 · DOI 10.3390/biomedicines10061288 -
Cholestasis: exploring the triangular relationship of gut microbiota-bile acid-cholestasis and the potential probiotic strategies.
Yu L, Liu Y, Wang S, Zhang Q, et al · · 2023 · cited 40× · PMID 36864554 · DOI 10.1080/19490976.2023.2181930 -
Fibrotic Events in the Progression of Cholestatic Liver Disease.
Wu H, Chen C, Ziani S, Nelson LJ, et al · · 2021 · cited 36× · PMID 34062960 · DOI 10.3390/cells10051107 -
Exploring Advanced Therapies for Primary Biliary Cholangitis: Insights from the Gut Microbiota-Bile Acid-Immunity Network.
Guo Z, He K, Pang K, Yang D, et al · · 2024 · cited 18× · PMID 38673905 · DOI 10.3390/ijms25084321 -
Emerging therapies for PBC.
Chascsa DMH, Lindor KD. · · 2020 · cited 16× · PMID 31970467 · DOI 10.1007/s00535-020-01664-0 -
Selected Aspects of the Intricate Background of Immune-Related Cholangiopathies-A Critical Overview.
Kasztelan-Szczerbinska B, Rycyk-Bojarzynska A, Szczerbinska A, Cichoz-Lach H. · · 2023 · cited 3× · PMID 36771465 · DOI 10.3390/nu15030760 -
Novel Therapies for Managing Cholestasis.
Santiago P, Levy C. · · 2020 · cited 3× · PMID 32257119 · DOI 10.1002/cld.886
Verify or expand the search:
- PubMed search for NCT03521297
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Primary Biliary Cholangitis (PBC)
Currently open trials in the same condition.
- NCT07449793 — Biochemical Response and Clinical Outcomes in Patients With PBC · recruiting
- NCT07296458 — FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy · Phase 3 · recruiting
- NCT07149675 — PBC Long-term Outcomes Study · recruiting
- NCT07161245 — RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis · NA · recruiting
- NCT06016842 — A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis · Phase 3 · recruiting
Other Sun Yat-sen University trials
Trials by the same sponsor.
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- NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
- NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
- NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03521297 (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 Sun Yat-sen University
- Last refreshed: 7 January 2020
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/NCT03521297.
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