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Effects of probiotics compared to placebo in combination with dietary and lifestyle modification on clinical, biochemical and radiological parameters in obese children with NASH (Non Alcoholic Steatohepatitis)/ NAFLD (Non Alcoholic Fatty Liver Disease). -

SLCTR Registration Number

SLCTR/2016/021


Date of Registration

27 Jul 2016

The date of last modification

Jul 26, 2017



Application Summary


Scientific Title of Trial

Effects of probiotics compared to placebo in combination with dietary and lifestyle modification on clinical, biochemical and radiological parameters in obese children with NASH (Non Alcoholic Steatohepatitis)/ NAFLD (Non Alcoholic Fatty Liver Disease).


Public Title of Trial

Effect of Probiotics in the management of fatty liver disease in obese children.


Disease of Health Condition(s) Studied

Non alcoholic fatty liver disease and Non alcoholic steato hepatitis in Obese children.


Scientific Acronym

None


Public Acronym

None


Brief title

Effects of probiotics in the management of NAFLD/NASH in obese children


Universal Trail Number

U1111-1162-7629


Any other number(s) assigned to the trial and issuing authority

EC-16-030 (ERC: Colombo)


Trial Details


What is the research question being addressed?

What are the effects of probiotics compared to placebo when used in combination with dietary and lifestyle modification on clinical, biochemical and radiological parameters in obese children with NASH (Non Alcoholic Steatohepatitis)/ NAFLD (Non Alcoholic Fatty Liver Disease)?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Intervention(s) planned

The study will be carried out at the Obesity clinic conducted by Ward 01 (Professorial Pediatric Unit of University of Colombo) Lady Ridgeway Hospital for Children.

A computer generated random number table will be used to register and allocate participating children into the intervention and control arms.

The intervention arm will receive structured diet + physical activity+ probiotics

Interventional product: Bio-Kult 14 strain probiotic capsule produced by Protexin Health care, Probiotics International Ltd, Somerset, UK. Dispensing will be as follows

• Under 12 yrs: 1 capsule daily for a period of 6 months

• 12yrs or above: 1 capsule twice daily for a period of 6 months

The control arm will receive structured diet + physical activity + identical placebo, to be taken as above.

Dietary advice: will be given by a trained medical officer. It will be based on food based dietary guidelines produced by Ministry of Health (Jayatissa and Wickramasinghe, 2011). Age based portion size guide will be given to parents and children and guide them on the volume they should be eating. They will be given a chart to fill the number of portions that they will consume each day. Initially they will be asked to do it daily during the first week of each month.

Physical activity: Subjects will be instructed to engage in 60 minutes of daily physical activity which will help to burn calories and improve fitness. Activities such as brisk walking, swimming or indoor or outdoor physical activity. Even if they cannot perform them as a single activity, will be advised to carry out as short intensive sessions each lasting 15 -20 minutes to obtain a cumulative outcome of 60 min per day. They will be encouraged to convert daily activities into such sessions. A diary will be given to record the activity and time of the day that they had performed each day.

Outcomes will be assessed independently by a member of the research team, who will be blinded to the interventions.


Inclusion criteria

  1. Age limit: 5yrs - 15yrs
  2. Sex: males and females
  3. Body Mass Index +2 standard deviations (SD) above the median BMI for age reference (using WHO, 2007 standards)
  4. Diagnosis of NAFLD/ NASH with AST/ ALT ratio less than 1 and ultra sound scan evidence of NAFLD/ NASH.

Exclusion criteria

  1. Children with acute infection,
  2. Long term medications (> 3 months continuously)
  3. Long standing illness on long term medication
  4. Children with inherited conditions.
  5. Administration of antibiotics in the 2 month period before enrollment


Primary outcome(s)

  1. Reduction in Alanine transaminase (ALT), Aspartate aminotransferase (AST)
  2. Reversal of AST:ALT ratio
  3. Transient elastographic (fibroscan) assessment of stiffness of the liver and quantification of steatosis
  4. Ultrasound grade of NAFLD/ NASH.

Primary outcome(s) - Time of assessment(s)

At baseline (just before commencement of therapy) and 6 months after completion of the course of therapy.


Secondary outcome

  1. Reduction in GT (gamma glutamyl transferase),
  2. Improvement of the lipid profile
  3. Improvement in glucose homeostasis, metabolic syndrome, fat mass of body and anterior abdominal wall subcutaneous fat
  4. Improvement of anthropometric parameters.

Secondary outcome(s) - Time of assessment(s)

  1. Reduction in GT (gamma glutamyl transferase),
  2. Improvement of the lipid profile
  3. Improvement in glucose homeostasis, metabolic syndrome, fat mass of body and anterior abdominal wall subcutaneous fat
  4. Improvement of anthropometric parameters.


Target number/sample size

170 total (85 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2016-08-15


Anticipated end date

2017-04-30


Recruitment status

Recruiting


State of ethics review approval

Approved by the Ethics Review of Committee of the Faculty of Medicine, University of Colombo on 3rd May 2016 (Ref: EC-16-030)


Funding source

None



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

V. Pujitha Wickramasinghe
Professor in Paediatrics
Department of Paediatrics, Faculty of Medicine, University of Colombo, Kynsey Road, Colombo 08
+94112688748
+94777766595
+94112691581
pujithaw@yahoo.com

Contact Person for Public Queries

V. Pujitha Wickramasinghe
Professor in Paediatrics
Department of Paediatrics, Faculty of Medicine, University of Colombo, Kynsey Road, Colombo 08
+94112688748
+94777766595
+94112691581
pujithaw@yahoo.com


Primary study sponsor/organization

Department of Paediatrics, Faculty of Medicine, University of Colombo

No. 25, Kynsey Road, Colombo 08
Tel: +94112688748
Fax: +94112691581

http://www.med.cmb.ac.lk

Secondary study sponsor (If any)

None