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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 -

SLCTR Registration Number

SLCTR/2018/042


Date of Registration

31 Dec 2018

The date of last modification

Dec 31, 2018



Application Summary


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


Trial Details


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

Single


Purpose

Treatment


Phase

Phase 0


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

Thirty (30)


Countries of recruitment

Sri Lanka


Anticipated start date

2019-01-07


Anticipated end date

2019-01-07


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Self funded



State of Ethics Review Approval


Status


Date of Approval


Approval number


Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Maheshani Wimalathunga
Dietician and Nutritionist
Durdans Hospital, 3, Alfred place, Colombo 3
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.
011- 2688649
077- 7777862
0112697757
director@pgim.cmb.ac.lk


Primary study sponsor/organization

Durdans Hospital, 3, Alfred place, Colombo 3

3, Alfred place, Colombo 3



Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description


Study protocol available


Protocol version and date


Protocol URL


Results summary available


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results