Home » Trials » SLCTR/2016/021
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
The date of last modification
Mar 03, 2019
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 or 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 Trial Number
U1111-1162-7629
Any other number(s) assigned to the trial and issuing authority
EC-16-030 (ERC: Colombo)
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
Study Phase
Phase 4
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
Exclusion criteria
Primary outcome(s)
|
1.
|
[ At baseline (just before commencement of therapy) and 6 months after completion of the course of therapy. ] |
Secondary outcome(s)
|
1.
|
[ Outcomes 1-3 will be measured at baseline and at 6 months following commencement of the intervention Outcome 4 will be measured at baseline and then monthly for a total of 6 months ] |
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
Date of first enrollment
2017-07-24
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2016-04-28
Approval number
EC-16-030
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | erckelaniya@gmail.com |
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
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
