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The effect of a synbiotic (probiotic and prebiotic) supplementation on patients with Non-Alcoholic Fatty Liver Disease (NAFLD): A proof of concept study

The effect of a synbiotic (probiotic and prebiotic) supplementation on patients with Non-Alcoholic Fatty Liver Disease (NAFLD): A proof of concept study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2018/042
Enrollment
Unknown
Registered
2018-12-31
Start date
2019-01-07
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

The study will be conducted at the Dietetic and Nutrition Clinic of Durdans hospital, Colombo-03. Subjects for the treatment and control will be randomly assigned using a random number table. At th

Sponsors

Durdans Hospital, 3, Alfred place, Colombo 3
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects who are diagnosed to have NAFLD by a medical officer or a medical consultant [based on hepatic ultrasonography and elevated levels (>1.5xUpper Limit) of alanine aminotransferase (ALT) concentration] and are referred to a registered Dietician & Nutritionist. Age between 30-55 years

Exclusion criteria

Exclusion criteria: Subjects having other acute or chronic liver diseases of other etiologies (viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, hereditary haemochromatosis, Wilson's disease, drug induced liver injury; cholestasis). Subjects who are pregnant and / or lactating Subjects who have history of malignancy, history of significant alcohol consumption (>14 units/week for men, >7 units/week for females) Subjects who are taking antibiotics, probiotics, vitamin, mineral, antioxidants, omega-3 or any other food supplements preceding enrollment Subjects who are on treatment with vitamin E, statins within 3 months prior to the starting date of the research.

Design outcomes

Primary

MeasureTime frame
Reduction in levels of Aspartate Transaminase (AST), Alanine Transaminase (ALT) and Gamma Glutamyl Transpeptidase (GGT). [At the baseline of the study and at 8 weeks]

Secondary

MeasureTime frame
Change in weight and BMI. Change in dietary measures (assessed using 24-h dietary recalls and semi quantitative food frequency questionnaire) Change in physical activity ( assessed using Short Form of the International Physical Activity Questionnaire. [At the baseline of the study and at 8 weeks]

Countries

Sri Lanka

Contacts

Public ContactMaheshani Wimalathunga

Dietician and Nutritionist

maheshaniwimalathunga@gmail.com011- 2140158

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026