BIFI-OBESE: Clinical Trial in Paediatric Obesity (BIFI-OBESE)
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|ClinicalTrials.gov Identifier: NCT03261466|
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : January 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity, Childhood||Drug: Bifidobacterium breve BR03 and Bifidobacterium breve B632 Drug: Placebos||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||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.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||BIFI-OBESE: Effect of Probiotic Bifidobacterium Breve BR03 and Bifidobacterium Breve B632 in Paediatric Obesity|
|Actual Study Start Date :||November 20, 2013|
|Actual Primary Completion Date :||October 30, 2017|
|Actual Study Completion Date :||October 30, 2017|
Active Comparator: Active group Bifidobacterium breve BR03 and B632
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
Other Name: probiotic
Placebo Comparator: Placebo group
This arm will receive a supplementation with a same product equal to the active product but without bifidobacterium inside.
Other Name: Placebo
- Change in glucose level during oral glucose tolerance test (OGTT) [ Time Frame: Change from Baseline OGTT (V0) at 2 months (V1), 3 months (V2) and 5 months (V3) ]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 in HOMA-IR index [ Time Frame: Change from baseline HOMA-IR (V0) at 2 months (V1), 3 months (V2) and 5 months (V3) ]Evaluate if after the treatment with probiotic there is a variation of HOMA-IR index.
- Metabolic control: Improvement of metabolic risk factors [ Time Frame: Change from baseline lipid profile, insulin, leptin, adiponectin, GLP1 (V0) at 2 months (V1), 3 months (V2) and 5 months (V3) ]Evaluate any variation of serum lipids, leptin, adiponectin, GLP1 and insulin during OGTT.
- Change in fecal microbiome [ Time Frame: Change from Baseline fecal microbiome (V0) at 2 months (V1), 3 months (V2) and 5 months (V3) ]Evaluate any variation of fecal microbiome
- Change in SCFA (short-chain fatty acids) in fecal samples [ Time Frame: Change from Baseline fecal SCFA (V0) at 2 months (V1), 3 months (V2) and 5 months (V3) ]Evaluate any variation of short-chain fatty acids in fecal samples
- Change in inflammatory cytokines [ Time Frame: Change from Baseline cytokines and metabolites (V0) at 2 months (V1), 3 months (V2) and 5 months (V3) ]Evaluate new citokines and metabolites that regulates hormone metabolism.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261466
|AOU Maggiore della Carità - Clinica Pediatrica - Ambulatorio di Auxologia ed Endocrinologia Pediatrica|
|Novara, Italy, 28100|