search
Back to results

Effects of Probiotics in Obese Children (Prob-esity)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Probiotics mixture
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring probiotics, obesity, oxidative stress

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children with obesity according to anthropometric measurements with appropriate weight for age

Exclusion Criteria:

  • coexistence of secondary obesity, malignancy, immune deficiency, collagen vascular diseases, congenital anomalies, neurological findings, children with receiving concomitant any drugs related chronic condition or antibiotics. Children with exogenous obesity who have also insulin resistance and /or hypertension were also excluded

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Probiotic mixture

    Control

    Arm Description

    Probiotic mixture including Lactobacillus acidophilus (4.3x108CFU/per sachet), Lactobacillus rhamnosus (4.3x108CFU/ per sachet), Bifidobacterium bifidum (4.3x108CFU/ per sachet), Bifidobacterium longum (4.3x108CFU/ per sachet), Enterococcus faecium (8.2x108CFU/ per sachet, per oral daily for 30 days in addition to standard approach

    Standard diet therapy

    Outcomes

    Primary Outcome Measures

    Obesity related anthropometric measurements
    Change of obesity related anthropometric measurements including weight, body mass index, upper arm circumference, tirceps skinfold thickness, waist and hip circumference

    Secondary Outcome Measures

    Evaluation of biochemical indices and oxidative stress
    Serum total cholesterol level, serum triglyceride level, serum LDL-C levels, serum HDL-C levels, serum total anti-oxidant capacity levels, serum total oxidative stress level
    Safety
    Side effects related with probiotic use: nausea, vomiting, other GIS disturbances, rash

    Full Information

    First Posted
    August 16, 2013
    Last Updated
    July 25, 2017
    Sponsor
    Eskisehir Osmangazi University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01927107
    Brief Title
    Effects of Probiotics in Obese Children
    Acronym
    Prob-esity
    Official Title
    Effects of Probiotics Mixture to Standard Diet Therapy in Obese Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    August 2013 (Actual)
    Study Completion Date
    August 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Eskisehir Osmangazi University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The global obesity epidemic presents an unprecedented challenge to the public health worldwide. The factors associated with obesity are complex, and include health behaviors, such as eating habits and daily physical activity, and broader social, environmental and biological determinants that influence these health behaviors. The intestinal microbiota has several beneficial functions related to host health and accumulating evidence indicates that the gut microbiota plays a significant role in the development of obesity, obesity-associated inflammation and insulin resistance. Experimental studies reveal a shift in the abundance of Bacteroidetes and Firmicutes. Presumably, obesity affects the diversity of the gut microbiota and, probably, the way individuals harvest energy from nutrients. Differences in community composition, functional genes and metabolic activities of the gut microbiota appear to distinguish lean vs obese individuals, suggesting that gut 'dysbiosis' contributes to the development of obesity and/or its complications. Recent studies have suggested some beneficial effects of probiotics and/or prebiotics on obesity and metabolic syndrome in adults; such experience is limited in children and adolescents. The aim of this study was to evaluate potential effects of add-on probiotics to standard therapy on anthropometric measurements, lipid profile and oxidative stress parameters in children.
    Detailed Description
    he global obesity epidemic presents an unprecedented challenge to the public health worldwide. The factors associated with obesity are complex, and include health behaviors, such as eating habits and daily physical activity, and broader social, environmental and biological determinants that influence these health behaviors. The intestinal microbiota has several beneficial functions related to host health and accumulating evidence indicates that the gut microbiota plays a significant role in the development of obesity, obesity-associated inflammation and insulin resistance. Experimental studies reveal a shift in the abundance of Bacteroidetes and Firmicutes. Presumably, obesity affects the diversity of the gut microbiota and, probably, the way individuals harvest energy from nutrients. Differences in community composition, functional genes and metabolic activities of the gut microbiota appear to distinguish lean vs obese individuals, suggesting that gut 'dysbiosis' contributes to the development of obesity and/or its complications. Recent studies have suggested some beneficial effects of probiotics and/or prebiotics on obesity and metabolic syndrome in adults; such experience is limited in children and adolescents. The aim of this study was to evaluate potential effects of add-on probiotics to standard therapy on anthropometric measurements, lipid profile and oxidative stress parameters in children.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    probiotics, obesity, oxidative stress

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotic mixture
    Arm Type
    Active Comparator
    Arm Description
    Probiotic mixture including Lactobacillus acidophilus (4.3x108CFU/per sachet), Lactobacillus rhamnosus (4.3x108CFU/ per sachet), Bifidobacterium bifidum (4.3x108CFU/ per sachet), Bifidobacterium longum (4.3x108CFU/ per sachet), Enterococcus faecium (8.2x108CFU/ per sachet, per oral daily for 30 days in addition to standard approach
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Standard diet therapy
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Probiotics mixture
    Intervention Description
    Comparison of probiotic mixture in addition to standard diet therapy vs. standart diet therapy
    Primary Outcome Measure Information:
    Title
    Obesity related anthropometric measurements
    Description
    Change of obesity related anthropometric measurements including weight, body mass index, upper arm circumference, tirceps skinfold thickness, waist and hip circumference
    Time Frame
    30th days
    Secondary Outcome Measure Information:
    Title
    Evaluation of biochemical indices and oxidative stress
    Description
    Serum total cholesterol level, serum triglyceride level, serum LDL-C levels, serum HDL-C levels, serum total anti-oxidant capacity levels, serum total oxidative stress level
    Time Frame
    30th days
    Title
    Safety
    Description
    Side effects related with probiotic use: nausea, vomiting, other GIS disturbances, rash
    Time Frame
    30th days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children with obesity according to anthropometric measurements with appropriate weight for age Exclusion Criteria: coexistence of secondary obesity, malignancy, immune deficiency, collagen vascular diseases, congenital anomalies, neurological findings, children with receiving concomitant any drugs related chronic condition or antibiotics. Children with exogenous obesity who have also insulin resistance and /or hypertension were also excluded
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ener C Dinleyici, MD
    Organizational Affiliation
    Eskisehir Osmangazi University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Probiotics in Obese Children

    We'll reach out to this number within 24 hrs