BIFI-OBESE: Clinical Trial in Paediatric Obesity

NCT03261466 | Completed Phase 4 DMC

• 1 other identifier: CE 165/13
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a major, public health concern that affects at least 400 million individuals and is associated with severe disorders including diabetes and cancers. Worldwide, the prevalence of overweight and obesity combined in children, adolescents and youth, between 1980 and 2013, increased to 47.1%, with alarming data also in developing countries. Obesity is often caused by imbalance between excessive caloric intake and reduced physical activity. Recently, microbial changes in the human gut was proposed to be another possible cause of obesity and it was found that the gut microbes from fecal samples contained 3.3 million non-redundant microbial genes. However, it is still poorly understood how the dynamics and composition of the intestinal microbiota are affected by diet or other lifestyle factors. Moreover it has been difficult to characterize the composition of the human gut microbiota due to large variations between individuals. The role of the digestive microbiota in the human body is still largely unknown, but the bacteria of the gut flora do contribute enzymes that are absent in humans for food digestion. Moreover, the link between obesity and the microbiota is likely to be more sophisticated than the simple phylum-level Bacteroidetes: Firmicutes ratio that was initially identified, and it is likely to involve a microbiota-diet interaction. Obese and lean subjects presented increased levels of different bacterial populations. It is hypothesized that the obese microbiome is set up to extract more calories from the daily intake when compared to the microbiome of lean counterparts. In addition, a caloric diet restriction impacted the composition of the gut microbiota in obese/overweight individuals and weight loss. In lean subjects there are Coriobacteriaceae, Lactobacillus, Enterococcus, Faecalibacterium prausnitzii, Prevotella, Clostridium Eubacterium, E. coli and Staphilococcus. By contrast, Bifidobacterium, Methanobrevibacter, Xylanibacter, Bacteroides characterize the composition of lean gut microbiota. For this reason, in a cohort of obese paediatric subjects with visceral adiposity, the aim of the study is to assess the efficacy of a supplementation with probiotic bifidobacteria with respect to a conventional treatment on weight loss and improvement of cardio-metabolic risk factors.

Conditions

Obesity, Childhood

Keywords

obesity; paediatric; probiotic

Outcome Measures

Primary Outcomes (2)

• Change in glucose level during oral glucose tolerance test (OGTT)

  Evaluate if after the treatment with probiotic there is a reduction of glucose values during the OGTT at time 0' e 120' after oral glucose tolerance test.

  Change from Baseline OGTT (V0) at 2 months (V1), 3 months (V2) and 5 months (V3)

• Change in HOMA-IR index

  Evaluate if after the treatment with probiotic there is a variation of HOMA-IR index.

  Change from baseline HOMA-IR (V0) at 2 months (V1), 3 months (V2) and 5 months (V3)

Secondary Outcomes (3)

• Metabolic control: Improvement of metabolic risk factors

  Change from baseline lipid profile, insulin, leptin, adiponectin, GLP1 (V0) at 2 months (V1), 3 months (V2) and 5 months (V3)

• Change in fecal microbiome

  Change from Baseline fecal microbiome (V0) at 2 months (V1), 3 months (V2) and 5 months (V3)

• Change in SCFA (short-chain fatty acids) in fecal samples

  Change from Baseline fecal SCFA (V0) at 2 months (V1), 3 months (V2) and 5 months (V3)

Other Outcomes (1)

• Change in inflammatory cytokines

  Change from Baseline cytokines and metabolites (V0) at 2 months (V1), 3 months (V2) and 5 months (V3)

Study Arms (2)

Active group Bifidobacterium breve BR03 and B632

ACTIVE COMPARATOR

This arm will receive a supplementation of probiotic containing Bifidobacterium breve B632 and Bifidobacterium breve BR03, 15 gtt/die (3x108 CFU/die) once a day.

Drug: Bifidobacterium breve BR03 and Bifidobacterium breve B632

Placebo group

PLACEBO COMPARATOR

This arm will receive a supplementation with a same product equal to the active product but without bifidobacterium inside.

Drug: Placebos

Interventions

Bifidobacterium breve BR03 and Bifidobacterium breve B632 DRUG

Also known as: probiotic

Active group Bifidobacterium breve BR03 and B632

Placebos DRUG

Also known as: Placebo

Placebo group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• both sexes
• between 6 and 18 years of age
• obese, according to the IOTF criteria (Cole TJ et al., 2000)
• pubertal stage ≥ 2 according to the Tanner stage (Tanner et al., 1961)
• HOMA-IR \> 2,5 or insulin \> 15 µU/ml

You may not qualify if:

• Adverse reactions to the product or component of the product (allergies…)
• Genetic obesity (Prader Willi syndrome, Down syndrome), Metabolic obesity (Laurence-biedl syndrome…), endocrinological obesity (Cushinch syndrome, hypotiroidism)
• Chronic diseases, hepatic or gastroenterological diseases
• Medical treatment for chronic diseases
• Probiotic or prebiotic therapies and antibiotic treatment

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

AOU Maggiore della Carità - Clinica Pediatrica - Ambulatorio di Auxologia ed Endocrinologia Pediatrica

Novara, 28100, Italy

Location

Related Publications (26)

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MeSH Terms

Conditions

Pediatric Obesity; Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is a triple blind study in which the treatment or intervention is unknown to the research participant, the individuals who administer the treatment or intervention, and the researchers who assess the outcomes.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor in Clinical Nutrition

Model Details: In the first part of the study (Study 1, V0-V1) patients will be randomized in a open-label, into two groups homogeneous for number and sex of the subjects. One group will receive a supplementation of probiotic containing Bifidobacterium breve B632 and Bifidobacterium breve BR03, 15 gtt/die (3x108 CFU/die) and one group will receive a placebo for a total of 2 months of treatment. For patients who wants to continue the study there will be a cross-over study (study 2, V2-V3) after one month of wash-out.

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: August 25, 2017
• Study Start: November 20, 2013
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: January 11, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)