| CTRI Number |
CTRI/2017/12/010997 [Registered on: 27/12/2017] Trial Registered Prospectively |
| Last Modified On: |
19/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The Effect of Probiotic VSL#3 and Lifestyle Intervention in Obese Children with Non-Alcoholic Fatty Liver Disease (NAFLD) |
|
Scientific Title of Study
|
The Effect of Probiotic VSL#3 and Lifestyle Intervention in Obese Children with Non Alcoholic Fatty Liver Disease(NAFLD):A Randomized Clinical Trial |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Babu Ram Thapa |
| Designation |
Former, Professor & Head |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Division of Pediatric Gastroenterology Hepatology and Nutrition
Post Graduate Institute of Medical Education and Research Chandigarh
Presently, Professor of Gastroenterology MM Medical Institute of Medical Sciences & Research (MMMISR)Mullana Ambala Haryana
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888552023 |
| Fax |
|
| Email |
brthapa1@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Pooja Goyal |
| Designation |
PhD Student |
| Affiliation |
Lovely Professional University Phagwara Punjab |
| Address |
Lovely Professional University
Phagwara Punjab
Lovely Professional University
Phagwara Punjab
Jalandhar
PUNJAB
144411
India |
| Phone |
9872033173 |
| Fax |
1824506111 |
| Email |
pooja_goyal9@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Goyal |
| Designation |
PhD Student |
| Affiliation |
Lovely Professional University Phagwara Punjab |
| Address |
Lovely Professional University
Phagwara Punjab
Lovely Professional University
Phagwara Punjab
Jalandhar
PUNJAB
144411
India |
| Phone |
9872033173 |
| Fax |
1824506111 |
| Email |
pooja_goyal9@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Babe Ke Ayurvedic Medical Hospital Moga Punjab |
|
|
Primary Sponsor
|
| Name |
Babe Ke Ayurvedic Hospital VPO Daudhar |
| Address |
VPO Daudhar Moga Punjab |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pooja Goyal |
ludhiana, Punjab |
After anthropometric assessment of obese children, schools of Jagraon city will be sent to Babe Ke medical hospital moga for free screening of NAFLD and blood test.
Ludhiana
PUNJAB |
9872033173
1824-506111
pooja_goyal9@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obese children with Non alcoholic Fatty Liver Disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
VSL#3 probiotic
live freeze dried lactic acid bacteria and bifidobacteria capsules |
4 capsules of VSL#3 probiotic less than 10yrs and 8 capsules above 10 yrs for 4 months |
| Comparator Agent |
Placebo capsules containing corn starch |
4 capsules for less than 10years
8 capsules above 10 years per day for child for 4 months |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Obese children in age group of 5-18 years old with NAFLD
(BMI) ≥95th or 85th to 94th percentile with risk factors
|
|
| ExclusionCriteria |
| Details |
Presence of liver disease due to hypothyroidism, wilson disease, viral hepatitis, cystic fibrosis, celiac disease, autoimmune hepatitis, drugs induced steatosis and gastrointestinal abnormalities. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the evaluation of beneficial effect of probiotic VSl#3 for the treatment of fatty liver disease in obese children |
4 months intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Probiotic VSL#3 for controlling the biochemical parameters LFT Lipid profile etc Hunger hormone leptin ghrelin |
4 months intervention |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "106"
Final Enrollment numbers achieved (India)="106" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/01/2018 |
| Date of Study Completion (India) |
07/01/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not Applicable
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a randomized double blind placebo controlled trial to study the supplementation with probiotic VSL#3 for the treatment of fatty liver disease in obese children.This study is for 24 months from the begining (surveying & recruiting 18 months@ VSL#3 supplementation & placebo for 4 months. This study population for screening will obese children and 100 will be recruited for participating in the trial from schools of jagraon city ludhiana and daudhar Punjab. 50% children for VSL#3 and another 50 %children for Placebo(corn starch). lifestyle (Diet and aerobic excercise) will be modified for the both groups. 4 capsules that contain 450 billion bacteria will provide to less than 10 yrs child and 8 capsules that contain 900 billion bacteria for above 10 yrs child dosage is defined by Pediatrician for 4 months intervention. The primary outcome is the evaluation of VSL#3 supplementation for treating fatty liver disease in obese children( reducing fatty liver grades). The secondary outcomes will be the effect of VSL#3 for controlling the biochemical parameters LFT lipid profile etc and leptin and ghrelin hormones.Anthropometric measurements also will be assessed before and after intervention.
|