Home » Trials » SLCTR/2018/042
The effect of a synbiotic (probiotic and prebiotic) supplementation on patients with Non-Alcoholic Fatty Liver Disease (NAFLD): A proof of concept study
-
SLCTR Registration Number
SLCTR/2018/042
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
The effect of a synbiotic (probiotic and prebiotic) supplementation on patients with Non-Alcoholic Fatty Liver Disease (NAFLD): A proof of concept study
Public Title of Trial
The effect of a synbiotic (probiotic and prebiotic) supplementation on patients with Non-Alcoholic Fatty Liver Disease (NAFLD): A proof of concept study
Disease or Health Condition(s) Studied
Non-Alcoholic Fatty Liver Disease
Scientific Acronym
None
Public Acronym
NAFLD
Brief title
Effect of a synbiotic on NAFLD
Universal Trial Number
U1111-1223-2767
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Is supplementation with synbiotics effective in reducing liver enzymes in patients with Non-Alcoholic Fatty Liver Disease?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 0 (exploratory trials)
Intervention(s) planned
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 the baseline of the study each participant will be provided with an individually tailored dietary recommendations and physical activity recommendations.
Fifteen (15) participants will be assigned to receive synbiotic capsule ( composition: Clostridium Butyricum - 2 Million Spores, Bacillus Mesentericus - 1 Million Spores, Strep Faeecalis - 30 Million Sproes, Lactobacillus Sporegens - 50 Million Spores), twice daily orally (one in the morning and one in the evening, between meals) for 8 weeks. Other fifteen (15) participants will only be provided with an individually tailored dietary recommendations and physical activity recommendations during the study period.
During the study period, all participants will be requested to avoid consuming probiotic containing foods or products (probiotic added yogurt, drinking yogurt, milk based nutrition supplements
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
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.
Primary outcome(s)
|
1.
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 outcome(s)
|
1.
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 ] |
Target number/sample size
30 (15 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2019-01-07
Anticipated end date
2019-09-07
Date of first enrollment
2019-01-07
Date of study completion
Recruitment status
Recruiting
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-10-16
Approval number
P/120/06/2018
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Maheshani Wimalathunga
Dietician and Nutritionist
Durdans Hospital, 3, Alfred Place, Colombo 3
Sri Lanka
011- 2140158
0711676489
N/A
maheshaniwimalathunga@gmail.com
Contact Person for Public Queries
Prof. H. Janaka De Silva
Director, Postgraduate Institute of Medicine.
160, Prof. Nandadasa Kodagoda Mawatha,
Colombo 07,
Sri Lanka
011- 2688649
077- 7777862
0112697757
director@pgim.cmb.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
