NCT05402449Completed
To Evaluate the Beneficial Effect of Probiotics on NAFLD Patients and the Role of Gut Microbiota Modulation
To Evaluate the Clinical Efficacy of Probiotic in Patients With NAFLD
Source: ClinicalTrials.gov · Last updated 5 Jul 2024
Brief summary (registry, in English)
In this study, the improvement of the clinical status of early-stage non-alcoholic fatty liver disease (NAFLD) patients after the probiotic intervention will be assessed. And the mechanism of probiotics to prevent the progression of illness would be investigated. The chronic inflammation status, systemic oxidative stress, metabolism of carbohydrates and lipid, and gut microbiota of NAFLD patients will also be analyzed.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 5 May 2022
- Start date
- 14 Jul 2022
- Primary completion date
- 31 May 2024
- Lead sponsor
- GenMont Biotech Incorporation
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05402449
What you commit to
- Study type: Interventional
- Participants enrolled: 70
- From 14 Jul 2022 to the primary completion date, 31 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The subject had previously received weight reduction surgery
Other illness
- Patients with liver diseases, HBV(hepatitis B virus), HCV(hepatitis C virus), Primary Biliary Cholangitis.
- Autoimmune system disease
- Wilson's disease
- Patients with uncontrolled malignancy
- Patient who have severe allergy to soybeans or peanuts
Lab values
- Taking Antibiotics, probiotics, or any other drugs that affect NAFLD or glucose and lipid metabolism in past 2 months
Other
- Alcoholic consumption (Female ≥ 10g/day or Male ≥ 20g/per)
- Hereditary hemochromatosis
- Pregnant or lactating female patients
Who the study is looking for
- Diagnosis of Nonalcoholic fatty liver disease (NALFD) by ultrasound.
- The range of Alanine aminotransferase (ALT) blood test is 60-300 U/L
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fu Jen Catholic University Hospital Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.