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Clinical efficacy of faecal microbial transplantation (FMT) in metabolism-associated fatty liver disease

Clinical efficacy of faecal microbial transplantation (FMT) in metabolism-associated fatty liver disease - Clinical efficacy of faecal microbial transplantation in metabolism-associated fatty liver disease

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084740
Enrollment
Unknown
Registered
2024-05-23
Start date
2024-05-23
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MAFLD

Interventions

control:Pepcid treatment, twice a day , 3 capsules each time, orally,18 days
Treatment:The treatment group was treated with bacterial fluid transplantation combined with all-bacterial capsules. The operation is as follows: 1. Naso-jejunostomy tube: (1) the preferred method for
(2) at least 4 hours of fasting should be done before transplantation, to reduce the incidence of vomiting, reflux, and other adverse reactions
(3) Adults who choose to transplant in the way of nasoenteric tube are recommended to have a standard course of treatment for 3-6 days, 300ml/transplantation of enterobacterial fluid per day, each tra
after treatment, the patient maintains the head-low-feet-height lying position for rest and observation for at least 30 min. 3. Enterobacteria freeze-dried capsules: (1) Capsules are suitable for pati

Sponsors

Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-65 years old, regardless of gender; 2. Meet both Chinese and Western medical diagnostic standards; 3. Above the normal upper limit<serum ALT<=3 times the normal upper limit. 4. Fasting blood glucose<=7.0mmol/L; 5. Sign an informed consent form; 6. Those who have not taken other drugs for the treatment of non-alcoholic steatohepatitis, or have stopped using other drugs for NASH before being included in observation for 4 weeks.

Exclusion criteria

Exclusion criteria: 1) With other acute or chronic liver diseases. 2) Patients with combined serious primary diseases of the heart, brain, kidney and haematopoietic system. 3) Patients with acute fatty liver of pregnancy, lipoid deposition disease, focal fatty liver, hepatic fatty tumour, etc. 4) Patients with mental illness. 5) Women who are pregnant or preparing for pregnancy, breastfeeding women. 6) Unstable weight (>5% change in the previous 3 months). 7) Patients with diabetes mellitus who are being treated with insulin or oral hypoglycaemic agents; 8) Current use of medications (e.g., weight-loss medications, etc.) that may interfere with the action, absorption, or disposition of the study treatment, or clinical studies. 9) Contraindications to MRI (pacemakers, Klaus phobia, implantation of medical devices with ferromagnetic properties). 10) Patients with allergic idiosyncrasies. 11) Those who are unable to follow the treatment protocol to the letter. 12) Patients with previous or planned bariatric surgery during the study period. 13) Participation in an investigational new drug clinical study within 30 days prior to randomisation. 14) Any other condition that, in the opinion of the investigator, may impede compliance, prevent completion of the study, harm the health of the subject, or interfere with study outcomes. Translated with www.DeepL.com/Translator (free version)

Design outcomes

Primary

MeasureTime frame
MRI-PDFF;

Secondary

MeasureTime frame
ALT;AST;CAP;BMI;TG;TC;HDL;LDL;BFR;WHR;

Countries

China

Contacts

Public ContactXuehua Sun

Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

18721145778@163.com+86 21 2025 6506

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026