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PROBESITY-2: Synbiotics in Pediatric Obesity

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05162209
Acronym
PROBESITY-2
Enrollment
61
Registered
2021-12-17
Start date
2019-06-01
Completion date
2021-09-01
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Adolescent, Obesity, Childhood

Keywords

Obesity, Synbiotic, Microbiota, Microbiome

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.

Detailed description

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. 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.

Interventions

DIETARY_SUPPLEMENTSynbiotic

Oral sachet, for 12 weeks

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Randomized, double blind, placebo controlled clinical study

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change as percentage of anthropometric measurement12 weeksWaist circumference, hip circumference, waist/hip ratio, waist/height ratio
Change of glucose metabolism12 weeksReduction as percentage of HOMA-IR
Change of lipid metabolism12 weeksSerum total cholesterol, LDL-C, HDL-C, serum triglyceride
Change of Intestinal microbiota composition12 weeksChange of predominant bacterial genera

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026