In this study we aim to evaluate the effects of Probiotic on obesity in children. The subjects are included 46 overweight and obese children aged between 6-15 years. Subjects will be selected from referral cases of digestive and endocrine pediatric clinic and were randomly allocated in two groups, treatment and placebo. Inclusion criteria: overweight or obese children aged 6-15 years referring to Pediatric gastrointestinal or endocrine clinics. Exclusion criteria: Having any chronic disease such as diabetes, thyroid disorders, cardiovascular or digestive disorders
Intervention group followed a regime including a weight loss diet, exercise program and synbiotic capsules while placebo group had the same diet, activity schedule and received placebo capsules instead of synbiotic.
The main outcomes are growth indices.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509244976N4
Registration date:2015-10-12, 1394/07/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-12, 1394/07/20
Registrant information
Name
Hamid Ahanchian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2469
Email address
ahanchianh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2016-01-05, 1394/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of probiotic on clinical indexes of obesity in obese children
Public title
Effects of probiotics on obesity in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: overweight or obese children aged 6-15 years refering to Pediatric Gastrointestinal or Endocrine clinics
Exclusion criteria: Having any chronic disease such as diabetes; thyroid disorders; cardiovascular or digestive disorders; did not follow the intervention program regularly.
Age
From 6 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomized by Table of randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committe of Mashhad university of Medical Sciences
Height and weight were measured with a portable stadiometer and portable digital weight
Secondary outcomes
1
Description
BMI
Timepoint
Monthly for 3 months
Method of measurement
BMI formulla
Intervention groups
1
Description
Intervention group : ِDiet plus exercise program plus Synbiotic capsules (Protexin company, London, England) were composed of prebiotic (Fructooligosaccharides), and 100 million CFU combination of Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis (child specific) and Lactobacillus bulgaricus daily for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Diet plus exercise program plus Placebo for 12 weeks in control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem educational hospital
Full name of responsible person
Dr Hamid Ahanchian
Street address
Ghaem Hospital, Ahmad abad Ave. , Taghabad sq. , Mashhad, Iran
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research, Mashhad University of medical sciences.