Evaluation of the Outcome of Fecal Microbiota Transplantation
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAir Force Military Medical University, China
About this trial
This study is a randomized, placebo-controlled, exploratory phase II clinical trial led by Professor Han Gyeong-ho from the Digestive Disease Hospital of Xi'an International Medical Center. The study enrolled 40 patients who had experienced recurrence of hepatic encephalopathy despite treatment with rifaximin and lactulose. These patients were randomly divided 1:1 into the experimental group and the control group. After obtaining informed consent from the patients, fecal microbiota transplantation or placebo control was performed. The fecal microbiota was sourced from the feces of healthy individuals who had a rich composition of the Muribaculaceae, Ruminococcaceae, and Bifidobacteriaceae families and did not contain pathogenic bacteria. The safety and efficacy of the treatment were followed up, and blood and fecal samples were collected for sequencing analysis. The aim was to provide new solutions for patients with hepatic encephalopathy who did not respond to the treatment with rifaximin and lactulose after TIPS surgery; and to explore the impact of microbiota changes and translocation on the recurrence of hepatic encephalopathy after TIPS surgery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged between 18 and 75 years old
Patients who have experienced esophageal-gastric variceal bleeding or recurrent refractory ascites and meet the inclusion criteria, and for whom conservative treatment has failed, are planned to undergo elective TIPS surgery
Patients with recurrent hepatic encephalopathy (HE) after transjugular intrahepatic portosystemic shunt (TIPS), despite treatment with lactulose and rifaximin (at least 2 episodes of West Haven grade ≥2 HE within 6 months under lactulose and rifaximin intervention)
Provided written informed consent from the patient
Disqualifiers
Malignant tumors of the liver, gastrointestinal tract or other systems
Uncontrolled severe active infection (>grade 2) or sepsis
Spontaneous bacterial peritonitis
Complicated with severe cardiac, renal or pulmonary insufficiency
Trial design
Design model
Parallel
Treatments tested in this trial
Fecal Microbiota Transplantation
Biological/VaccineFecal microbiota transplantation is used to reconstruct gut microbiota structure, regulate intestinal microecological homeostasis, improve intestinal barrier function, reduce systemic endotoxin load and inflammatory level, for the prevention and treatment of refractory hepatic encephalopathy after TIPS. The preparation is made from stool of qualified screened donors, processed under sterile conditions.
FMT Matched Placebo
Other interventionPlacebo preparation is identical to fecal microbiota transplantation preparation in appearance, dosage form, administration route and frequency, with no active biological or therapeutic components, used for the control arm of this randomized controlled trial.
Rifaximin、Lactulose
DrugRifaximin is a non-absorbable oral rifamycin antibiotic, used as standard medical therapy for hepatic encephalopathy, to reduce intestinal urease-producing bacteria and intestinal ammonia production.Lactulose is a synthetic disaccharide laxative, used as first-line standard medical therapy for hepatic encephalopathy, to acidify the intestinal lumen, reduce ammonia production and promote ammonia excretion.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Fecal Microbiota Transplantation GroupExperimental treatment 2 interventions
Group B: Placebo Control GroupPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Incidence and severity of treatment-related adverse events (AEs) and serious adverse events (SAEs)
Record the number, incidence, severity (graded by NCI-CTC v3.0 criteria), correlation with trial intervention, and outcome of all AEs, FMT-related AEs and SAEs in subjects from randomization to the end of follow-up. Key monitoring includes gastrointestinal reactions, infection, exacerbation of hepatic encephalopathy and other intervention-related adverse events.
Time frame
From the date of randomization to the end of 6-month follow-up after interventionSecondary outcomes
1
The recurrence rate of hepatic encephalopathy fecal microbiota transplantation intervention
The ratio of the number of patients with recurrent hepatic encephalopathy to the total number of patients in each group
Time frame
From the date of randomization to the end of 6-month follow-up after intervention2
The changes in health-related quality of life after fecal microbiota transplantation intervention
The health-related quality of life was evaluated through the Chronic Liver Disease Questionnaire (CLDQ), with the lowest score being 1 and the highest score being 7. The higher the score, the better the health-related quality of life.
Time frame
Baseline, 1 month after intervention, 3 months after intervention, 6 months after intervention3
The colonization status of the intestinal microbiota
The survival rate (%) of the donor microbiota in the patient's intestinal tract
Time frame
Baseline, 15 days after intervention, 1 month after intervention, 3 months after intervention, 6 months after intervention4
Changes in the α diversity of the intestinal microbiota
Using metagenomic sequencing technology, the α diversity of the intestinal microbiota (Shannon index, Simpson index) was evaluated.
Time frame
Baseline, 15 days after intervention, 1 month after intervention, 3 months after intervention, 6 months after interventionSponsors and contacts
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Source ClinicalTrials.gov
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