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Trial record 3 of 5 for:    15477412 [PUBMED-IDS]

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
Sponsor:
Information provided by (Responsible Party):
Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita

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.


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
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Placebos
Other Name: Placebo




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261466


Locations
Italy
AOU Maggiore della Carità - Clinica Pediatrica - Ambulatorio di Auxologia ed Endocrinologia Pediatrica
Novara, Italy, 28100
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita

Publications:
Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29. Erratum in: Lancet. 2014 Aug 30;384(9945):746.
Società Italiana di Nutrizione Umana.(2014).Livelli di assunzione raccomandati di energia e nutrienti per la popolazione italiana (LARN). Milan, Italy: S.I.N.U.
Tanner JM. (1961). Growth at adolescence. 2 edn. Oxford: Blackwell Scientific Publications.

Responsible Party: Flavia Prodam, Assoc. Professor in Clinical Nutrition, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT03261466     History of Changes
Other Study ID Numbers: CE 165/13
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita:
obesity
paediatric
probiotic

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms