primary biliary cholangitis
Conditions
Interventions
Experimental group:Oral fecal microbiota capsules
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Between the ages of 40 and 60 (inclusive). 2. Patients diagnosed with PBC. PBC can be diagnosed if any two of the following three criteria are met: serum biochemical evidence reflecting bile stasis, such as elevated ALP; positive serum AMA/AMA-M2 or anti-sp100/anti-gp210 antibodies; and histological changes suggesting non-suppurative destructive cholangitis and interlobular bile duct destruction. Differential diagnosis should be made with drug-induced cholestasis, alcoholic liver cirrhosis, obstructive cholestasis, sarcoidosis, AIH, PSC, and other diseases. 3. Patients with incomplete UDCA response. Complete UDCA response is defined as normalization of alkaline phosphatase (ALP), gamma-glutamyl transferase (?-GT), and total bilirubin (TBil) for at least 6 months after standard UDCA treatment (13-15mg/kg/day). Therefore, patients with incomplete UDCA response have at least one of the three biochemical indicators above 1 times the upper limit of normal (ULN), i.e., ALP>1×ULN, or ?-GT>1×ULN, or TBil>1×ULN. 4. Patients who have been using UDCA for at least 12 months before screening, and whose stable dose has been maintained for more than 3 months before screening. 5. A written informed consent must be provided and the trial protocol must be agreed to.
Exclusion criteria
Exclusion criteria: 1. MELD score >17; 2. Absolute WBC count 15mg/day; 11. Chronic endogenous gastrointestinal diseases (ulcerative colitis, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease); 12. Safety-related issues: consciousness disorders, swallowing difficulties, history of aspiration, gastroparesis, intestinal obstruction, intestinal perforation, and intestinal bleeding; severe allergic food allergies; allergy to recognized safe ingredients in bacterial capsules (glycerol), sodium chloride, hydroxypropyl cellulose, gelatin, titanium dioxide, and cocoa butter); American Society of Anesthesiologists (ASA) grade IV or V; pregnant or lactating patients; FMT for acute illnesses or fever on the day of treatment; 13. Patients expected to not survive during the study period (90 days), or subjects whose physical condition is deemed inappropriate for FMT by the investigator; 14. Patients who have previously received liver transplantation; 15. History of gastrointestinal surgery (such as gastric bypass surgery) or cholecystectomy; 16. Participation in another clinical trial within the past 30 days or during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A decrease of =50% or restoration to normal levels in ALP, GGT, and TBil.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of participants with a decrease in ALP by 10%, 20%, and 40%;The change in alanine aminotransferase (ALT) levels from baseline;The change in alanine aminotransferase (ALT) levels compared from baseline;The change in gamma-glutamyl transferase (GGT) from baseline;The change in total bilirubin (TBil) from baseline;The change in total bile acid (TBA) from baseline;The change in immunoglobulin M (IgM) from baseline;The change in ESR (erythrocyte sedimentation rate) and hsCRP (high-sensitivity C-reactive protein) levels from baseline;The change in AMA-M2, sp100, or gp210 autoantibody titers from baseline;The change in abdominal ultrasound assessment of ascites grading from baseline in the PBC patients with decompensated liver function;The changes in the score of the Primary Biliary Cholangitis-40 (PBC-40) Quality of Life questionnaire compared to baseline; | — |
Countries
China
Contacts
Public ContactXin You
Peking Union Medical College Hospital
Outcome results
None listed