| Trial ID: | L0844 |
| Source ID: | SLCTR/2016/021
|
| Associated Drug: |
Probiotic
|
| Title: |
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).
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non alcoholic fatty liver disease and Non alcoholic steato hepatitis in Obese children.
|
| Interventions: |
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.<br><br>A computer generated random number table will be used to register and allocate par
|
| Outcome Measures: |
1. Reduction in Alanine transaminase (ALT), Aspartate aminotransferase (AST) <br>2. Reversal of AST:ALT ratio<br>3. Transient elastographic (fibroscan) assessment of stiffness of the liver and quantification of steatosis<br>4. Ultrasound grade of NAFLD/ NASH.<br> [At baseline (just before commencement of therapy) and 6 months after completion of the course of therapy.]<br>1. Reduction in GT (gamma glutamyl transferase),
<br>2. Improvement of the lipid profile
<br>3. Improvement in glucose homeostasis, metabolic syndrome, fat mass of body and anterior abdominal wall subcutaneous fat
<br>4. Improvement of anthropometric parameters.
<br> [Outcomes 1-3 will be measured at baseline and at 6 months following commencement of the intervention
<br>
<br>Outcome 4 will be measured at baseline and then monthly for a total of 6 months
<br>]<br>
|
| Sponsor/Collaborators: |
Department of Paediatrics, Faculty of Medicine, University of Colombo
|
| Gender: |
--
|
| Age: |
nannan
|
| Phases: |
Phase 4
|
| Enrollment: |
170 total (85 in each arm)
|
| Study Type: |
Interventional
|
| Study Designs: |
Randomized controlled trial
|
| Start Date: |
27/07/2016
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
7 February 2022
|
| Locations: |
Sri Lanka
|
| URL: |
https://slctr.lk/trials/slctr-2016-021
|
