PROBESITY-2: Synbiotics in Pediatric Obesity

NCT ID: NCT05162209

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2021-09-01

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.

Conditions

Obesity, Childhood; Obesity, Adolescent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Synbiotic

Intervention Type: DIETARY_SUPPLEMENT

Oral sachet, for 12 weeks

Placebo

Oral sachet daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Synbiotic

Intervention Type: DIETARY_SUPPLEMENT

Oral sachet, for 12 weeks

Interventions

Synbiotic

Oral sachet, for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: lead

Responsible Party

Ener Cagri DINLEYICI

Professor in Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ener C Dinleyici, MD

Role: PRINCIPAL_INVESTIGATOR

Eskisehir Osmangazi University Faculty of Medicine

Locations

Eskisehir Osmangazi University Faculty of Medicine

Eskişehir, Odunpazarı, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Kilic Yildirim G, Dinleyici M, Vandenplas Y, Dinleyici EC. Effects of synbiotic supplementation on intestinal microbiota composition in children and adolescents with exogenous obesity: (Probesity-2 trial). Gut Pathog. 2023 Jul 21;15(1):36. doi: 10.1186/s13099-023-00563-y.

Reference Type: DERIVED

PMID: 37474971 (View on PubMed)

Kilic Yildirim G, Dinleyici M, Vandenplas Y, Dinleyici EC. Effects of Multispecies Synbiotic Supplementation on Anthropometric Measurements, Glucose and Lipid Parameters in Children With Exogenous Obesity: A Randomized, Double Blind, Placebo-Controlled Clinical Trial (Probesity-2 Trial). Front Nutr. 2022 Jul 1;9:898037. doi: 10.3389/fnut.2022.898037. eCollection 2022.

Reference Type: DERIVED

PMID: 35845797 (View on PubMed)

Other Identifiers

PROB2018

Identifier Type: -

Identifier Source: org_study_id