---
title: Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response
nct_id: NCT03590886
overall_status: COMPLETED
sponsor: Sun Yat-sen University
study_type: OBSERVATIONAL
primary_condition: Primary Biliary Cirrhosis
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03590886.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03590886"
ct_last_update_post_date: 2019-12-24
last_seen_at: "2026-05-12T07:04:18.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response

**Official Title:** A Clinical Study About Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response

**NCT ID:** [NCT03590886](https://clinicaltrials.gov/study/NCT03590886)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Sun Yat-sen University
- **Conditions:** Primary Biliary Cirrhosis
- **Start Date:** 2018-08-22
- **Completion Date:** 2019-02-28
- **CT.gov Last Update:** 2019-12-24

## Brief Summary

To compare intestinal flora diversity in different PBC patients with UDCA responses, and further study the differences of bile acid metabolism and short chain fatty acid metabolism in feces and serum of two groups of PBC patients.

## Detailed Description

The PBC patients have been enrolled in the study for UDCA treatment more than 1 year, who is divided into the UDCA total response Group and the other poor response group according to Paris-I/II standard .The feces of two groups of patients were collected and the differences of microbial polymorphism of fecal microorganism in two groups were observed. The metabolic differences of bile acids and short chain fatty acids in serum and feces of two groups of PBC patients were studied by means of metabolic proteomics.

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1.Confirmed diagnostic criteria about PBC, and orally UDCA treatment for more than a year; 2.30-70 years old; 3.Currently only UDCA therapy, not glucocorticoids and immunosuppressor treatment.

Exclusion Criteria:

1. Viral liver disease;
2. alcoholic liver disease;
3. fatty liver;
4. drug-associated liver damage;
5. infectious disease;
6. obesity;
7. gastrointestinal diseases;
8. combined with other autoimmune diseases;
9. cardiac and pulmonary dysfunction;
10. renal dysfunction, malignant tumor,;
11. neurological and psychiatric abnormalities;
12. nearly 2 months to take antibiotics and probiotics;
13. nearly 3 months participate in other drug clinical trials .
```

## Arms

- **total response Group** — The PBC patients show biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard
- **poor response group** — The PBC patients show poor biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard

## Interventions

- **total response Group** (OTHER) — biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard

## Primary Outcomes

- **fecal microbial diversity** _(time frame: 6 months)_ — Macrogenomic examination of fecal microbial DNA

## Secondary Outcomes

- **bile acid metabolites** _(time frame: 6 months)_
- **short chain fatty acid metabolites** _(time frame: 6 months)_

## Locations (1)

- The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the third affiliated hospital of sun yat-sen university|guangzhou|guangdong|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03590886*  
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