Probiotic Supplement Versus Placebo for the Treatment of Patients With Non-alcoholic Fatty Liver Disease
NCT ID: NCT06491342
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2024-07-25
2025-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Maltodextrin in bovine gelatin capsule look same as probiotic (250 mg/capsule ) 2 capsule twice daily after breakfast and dinner
Placebo
placebo
probiotic
Lactobacillus Zeae and Lactobacillus reuteri probiotic mixed with Maltodextrin in ratio 15:85 in bovine gelatin capsule (250 mg/capsule ) 2 capsule twice daily after breakfast and dinner (1,000 mg =1x109 CFU/g)
Probiotic
Probiotic-Lactobacillus Zeae and Lactobacillus reuteri
Interventions
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Probiotic
Probiotic-Lactobacillus Zeae and Lactobacillus reuteri
Placebo
placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Previous antibiotic/antifungus within 1 month
3. History of significant alcohol consumption for a period of more than three consecutive months within 1 year before screening. Significant alcohol consumption is defined as equal to or greater than approximately two alcoholic drinks per day for males and approximately 1.5 alcoholic drinks per day for females
4. Regular use of drugs historically associated with NAFLD, which include, but are not limited, to the following: amiodarone, methotrexate, systemic glucocorticoids at greater than 5 mg/d
5. Chronic liver diseases from other cause such as viral hepatitis, autoimmune hepatitis
6. Hepatic decompensation or impairment defined as presence of any of the following:
* History of esophageal varices, ascites or hepatic encephalopathy.
* Serum albumin \<3.5 g dl-1, except as explained by nonhepatic causes.
* INR \> 1.4
7. Use of GLP-1 agonist therapy (for example, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide and albiglutide), vitamin E and pioglitazone
8. Active autoimmune disease, including actively treated lupus, rheumatoid arthritis, inflammatory bowel disease
9. Active malignancy on treatment
10. New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \<30%
11. Known immunocompromised status, HIV or who have recurrent or chronic systemic bacterial, fungal, viral or protozoal infections
12. Respiratory compromised
13. Severe renal impairment (eGFR \<30 ml/min/1.73 m2)
14. Pregnancy
20 Years
80 Years
ALL
Yes
Sponsors
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Chiang Mai University
OTHER
Thailand Institute of scientific and technological research
UNKNOWN
Phramongkutklao College of Medicine and Hospital
OTHER
Responsible Party
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Principal Investigators
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Natchaporn Noppacroh
Role: PRINCIPAL_INVESTIGATOR
phramongkutklao
Locations
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Division of gastroenterology and hepatology
Ratchathewi, Bangkok, Thailand
Chiangmai university
Chiang Mai, , Thailand
Countries
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References
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Other Identifiers
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PMK GI 001
Identifier Type: -
Identifier Source: org_study_id
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