PROBESITY-2: Synbiotics in Pediatric Obesity

Sponsor

Eskisehir Osmangazi University (Other)

Overall Status

Completed

CT.gov ID

NCT05162209

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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 behaviours, such as eating habits and daily physical activity, and broader social, environmental and biological determinants that influence these health behaviours. 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. 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. There are limited information about the synbiotics in children and adolescent with obesity.The mechanism of action of probotics on obesity are scarce and microbiota restoration/reshaping might be the one. The objective of this study tested the effects of a multispecies synbiotic on anthropometric measurement, glucose metabolism, lipid parameters and intestinal microbiota in children with exogenous obesity.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Childhood Obesity, Adolescent	Dietary Supplement: Synbiotic	N/A

Detailed Description

This is a randomized, double-blind, placebo-controlled clinical study with 61 children, aged between 8 to 17 years-old, with exogenous obesity which received a daily dose of a multispecies symbiotic formulation or a placebo for 12 weeks. At entry, the anthropometric measures included weight, height, waist and hip circumference were recorded. Waist circumference to height ratio, waist circumference to hip circumference ratio and body mass index (BMI) was calculated. Venous blood samples were drawn after a minimum 8 hours fasting for measures including serum glucose, insulin, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides, C-reactive protein (CRP), erythrocyte sedimentation rate; at admission and 12 weeks later. Both groups were treated with a standard diet and increased physical activity. Patients were randomly allocated into two groups in a ratio of 1:1. Randomization with permutated blocks was done using the online software tool. First group received a daily synbiotic supplementation which consisted of a daily probiotic mixture including Lactobacillus acidophilus), Lactobacillus rhamnosus, Bifidobacterium bifidum, Bifidobacterium longum, Enterococcus faecium (total 2.5 x109CFU/sachet), fructooligosaccharydes (FOS) 625 mg, lactulose 400 mg, vitamin A (6 mg), B1 (1.8 mg), B2 (1.6 mg), B6 (2.4 mg), E (30 mg), C (75 mg) for 12 weeks. Second group received placebo for 12 weeks. Each visit (Day 0 and 12 weeks later), stool samples were also collected. The V3 and V4 regions of the 16S rRNA gene were amplified following the 16S Metagenomic Sequencing Library Preparation. The primary end point of this study was to evaluate the effect of the multispecies synbiotic would on weight loss (reduction as percentage for weight and body mass index). Secondary endpoints were the evolution of the other anthropometeic measurements, glucose and lipid metabolism and intestinal microbiota composition.

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, double blind, placebo controlled clinical studyRandomized, double blind, placebo controlled clinical study

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

Effects Of Synbiotic Supplementation On Anthropometric Measurements, Glucose Metabolism, Lipid Parameters And Intestinal Microbiota Composition In Children With Exogenous Obesity: (Probesity-2 Study)

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Apr 30, 2021

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Synbiotic Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, Bifidobacterium longum, Enterococcus faecium (total 2.5 x10 9CFU/sachet), fructooligosaccharydes (FOS) 625 mg, oral sachet daily, for 12 weeks	Dietary Supplement: Synbiotic Oral sachet, for 12 weeks
Placebo Comparator: Placebo Oral sachet daily for 12 weeks	Dietary Supplement: Synbiotic Oral sachet, for 12 weeks

Arm

Intervention/Treatment

Experimental: Synbiotic

Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, Bifidobacterium longum, Enterococcus faecium (total 2.5 x10 9CFU/sachet), fructooligosaccharydes (FOS) 625 mg, oral sachet daily, for 12 weeks

Dietary Supplement: Synbiotic

Oral sachet, for 12 weeks

Placebo Comparator: Placebo

Oral sachet daily for 12 weeks

Dietary Supplement: Synbiotic

Oral sachet, for 12 weeks

Outcome Measures

Primary Outcome Measures

Change as percentage for weight and body mass index. [12 weeks]
% reduction comparing to baseline

Secondary Outcome Measures

Change as percentage of anthropometric measurement [12 weeks]
Waist circumference, hip circumference, waist/hip ratio, waist/height ratio
Change of glucose metabolism [12 weeks]
Reduction as percentage of HOMA-IR
Change of lipid metabolism [12 weeks]
Serum total cholesterol, LDL-C, HDL-C, serum triglyceride
Change of Intestinal microbiota composition [12 weeks]
Change of predominant bacterial genera

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Children and adolescents
Aged between 8 to 17 years old with exogenous obesity

Exclusion Criteria:

Children and adolescents with endogenous obesity
Children with adolescents with a history of gastrointestinal surgery
Children with adolescents with chronic intestinal disorders including inflammatory bowel disease
Children receiving probiotics and /or antibiotics 8 weeks prior this study.