PROBESITY-2: Synbiotics in Pediatric Obesity

NCT05162209 | Completed

• 1 other identifier: PROB2018
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood; Obesity, Adolescent

Keywords

Obesity; Synbiotic; Microbiota; Microbiome

Outcome Measures

Primary Outcomes (1)

• Change as percentage for weight and body mass index.

  % reduction comparing to baseline

  12 weeks

Secondary Outcomes (4)

• Change as percentage of anthropometric measurement

  12 weeks

• Change of glucose metabolism

  12 weeks

• Change of lipid metabolism

  12 weeks

• Change of Intestinal microbiota composition

  12 weeks

Study Arms (2)

Synbiotic

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Oral sachet daily for 12 weeks

Dietary Supplement: Synbiotic

Interventions

Synbiotic DIETARY_SUPPLEMENT

Oral sachet, for 12 weeks

Placebo; Synbiotic

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University Faculty of Medicine

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 37474971 DERIVED

• 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.

  PMID: 35845797 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Officials

• Ener C Dinleyici, MD

  Eskisehir Osmangazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Pediatrics

Model Details: Randomized, double blind, placebo controlled clinical study

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 17, 2021
• Study Start: June 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: September 1, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)