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Impact of B. Bifidum 900791 Intake on Breast Milk Characteristics of Obese Mothers

Primary Purpose

Maternal Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Maternal Obesity focused on measuring obesity, breast milk, probiotic, IL-6, CRP, Insulin, Adiponectin, Resistin, breastmilk microbiota, Bifidobacterium

Eligibility Criteria

20 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women in their last month of pregnancy, who were normal-weight (18.5<BMI<25kg/m2) or who were obese (BMI>30kg/m2) before pregnancy, and their children

Women recruited should have expressed their wish to have their child through normal delivery, and to breastfeed at least during the first month post-partum.

Exclusion Criteria:

  • Women with chronic diseases (type 2 diabetes, renal diseases, autoimmune diseases, tumor, chronic inflammatory diseases, etc.).
  • Women with a history of digestive surgery.
  • Women whose children are hospitalized more than 24hours in the neonatal unit
  • Women who require antibiotic treatment during the perinatal period.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Placebo Comparator

    Arm Label

    Experimental Obese mothers

    Placebo Obese mothers

    Experimental normal weight mothers

    Placebo normal weight mothers

    Arm Description

    One portion (50g) of an ice-cream containing the probiotic B. bifidum 900791 (>10(exp7)/g) every other day during the last month of gestation and the first month of lactation

    One portion (50g) of an ice-cream without probiotic every other day during the last month of gestation and the first month of lactation

    One portion (50g) of an ice-cream containing B. bifidum 900791 (>10(exp7)/g) every other day during the last month of gestation and the first month of lactation

    One portion (50g) of an ice-cream without probiotic every other day during the last month of gestation and the first month of lactation

    Outcomes

    Primary Outcome Measures

    C-Reactive Protein concentration in breastmilk
    Concentration of CRP in breastmilk

    Secondary Outcome Measures

    IL-6 concentration in breastmilk
    Concentration of IL-6 in breastmilk
    Insulin concentration in breastmilk
    Concentration of Insulin in breastmilk
    Resistin concentration in breastmilk
    Concentration of resistin in breastmilk
    Adiponectin concentration in breastmilk
    Concentration of adiponectin in breastmilk
    Milk microbiota diversity
    Intra-and Interindividual diversity of the milk microbiota
    Milk microbiota composition
    Relative abundancies of the different bacterial taxa detected by high throughput sequencing
    Presence of B. bifidum 900791 in breastmilk
    Presence of the probiotic strain B. bifidum 900791 in breastmilk
    Infant fecal microbiota diversity
    Intra-and Interindividual diversity of the infant fecal microbiota
    Infant fecal microbiota composition
    Relative abundancies of the different bacterial taxa detected by high throughput sequencing

    Full Information

    First Posted
    April 8, 2019
    Last Updated
    May 28, 2019
    Sponsor
    University of Chile
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03913364
    Brief Title
    Impact of B. Bifidum 900791 Intake on Breast Milk Characteristics of Obese Mothers
    Official Title
    Evaluation of B. Bifidum 900791 as a Modulator of Microbiota, Inflammatory Mediators and Metabolic Hormones in Breast Milk From Obese Mothers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2019 (Anticipated)
    Primary Completion Date
    August 30, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Chile

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Human breast milk harbours a specific microbiota including bacteria from the Lactobacillus and Bifidobacterium genera, that contribute to the bacterial colonization of the infant gut in the post-natal period. An entero-mammary pathway has been suggested by which selected bacteria from the maternal gut would be transmitted to the mammary gland through dendritic cell trafficking by the lymphatic pathway. Accordingly, some studies have detected the presence of probiotic strains in breast milk from mothers who were consuming them. The administration of probiotic supplements to lactating mothers has also been shown to modulate milk concentrations of inflammatory markers and metabolic hormones, impacting positively the infant health. Noteworthily, many of these inflammatory and hormonal biomarkers are altered in the breastmilk from pre-pregnancy obese mothers, compared with these who were normal-weight, possibly affecting the infant health. It is unclear whether the breast milk microbiota of obese mothers is altered and the impact of probiotic administration on the breastmilk microbiota and on the normalization of breastmilk alterations in obese mothers is unknown. Based on these antecedents, the aim of this study is to determine if the administration of a B. bifidum 900791-containing foodstuff to mothers during the perinatal period normalizes the breast milk concentrations of interleukin (IL)-6, C-Reactive Protein (CRP), insulin, adiponectin and resistin, and the microbiota of obese mothers, compared with normal-weight mothers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Maternal Obesity
    Keywords
    obesity, breast milk, probiotic, IL-6, CRP, Insulin, Adiponectin, Resistin, breastmilk microbiota, Bifidobacterium

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Obese mothers and normal-weight mothers will each be randomized in two groups to receive the probiotic product or the placebo. Colostrum and breastmilk samples will obtained at days 2 and 30 post-partum, respectively, and infant fecal samples at day 30.
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Obese mothers
    Arm Type
    Experimental
    Arm Description
    One portion (50g) of an ice-cream containing the probiotic B. bifidum 900791 (>10(exp7)/g) every other day during the last month of gestation and the first month of lactation
    Arm Title
    Placebo Obese mothers
    Arm Type
    Placebo Comparator
    Arm Description
    One portion (50g) of an ice-cream without probiotic every other day during the last month of gestation and the first month of lactation
    Arm Title
    Experimental normal weight mothers
    Arm Type
    Experimental
    Arm Description
    One portion (50g) of an ice-cream containing B. bifidum 900791 (>10(exp7)/g) every other day during the last month of gestation and the first month of lactation
    Arm Title
    Placebo normal weight mothers
    Arm Type
    Placebo Comparator
    Arm Description
    One portion (50g) of an ice-cream without probiotic every other day during the last month of gestation and the first month of lactation
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Probiotic
    Other Intervention Name(s)
    Bifidice
    Intervention Description
    B. bifidum 900791-containing ice cream
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo ice-cream
    Primary Outcome Measure Information:
    Title
    C-Reactive Protein concentration in breastmilk
    Description
    Concentration of CRP in breastmilk
    Time Frame
    Day-30
    Secondary Outcome Measure Information:
    Title
    IL-6 concentration in breastmilk
    Description
    Concentration of IL-6 in breastmilk
    Time Frame
    Day 30
    Title
    Insulin concentration in breastmilk
    Description
    Concentration of Insulin in breastmilk
    Time Frame
    Day 30
    Title
    Resistin concentration in breastmilk
    Description
    Concentration of resistin in breastmilk
    Time Frame
    Day 30
    Title
    Adiponectin concentration in breastmilk
    Description
    Concentration of adiponectin in breastmilk
    Time Frame
    Day 30
    Title
    Milk microbiota diversity
    Description
    Intra-and Interindividual diversity of the milk microbiota
    Time Frame
    Day 30
    Title
    Milk microbiota composition
    Description
    Relative abundancies of the different bacterial taxa detected by high throughput sequencing
    Time Frame
    Day 30
    Title
    Presence of B. bifidum 900791 in breastmilk
    Description
    Presence of the probiotic strain B. bifidum 900791 in breastmilk
    Time Frame
    Day 30
    Title
    Infant fecal microbiota diversity
    Description
    Intra-and Interindividual diversity of the infant fecal microbiota
    Time Frame
    Day 30
    Title
    Infant fecal microbiota composition
    Description
    Relative abundancies of the different bacterial taxa detected by high throughput sequencing
    Time Frame
    Day 30
    Other Pre-specified Outcome Measures:
    Title
    Colostrum IL-6
    Description
    Concentrations of IL-6 in colostrum
    Time Frame
    Day 2
    Title
    Colostrum CRP
    Description
    Concentrations of CRP in colostrum
    Time Frame
    Day 2
    Title
    Colostrum insulin
    Description
    Concentrations of insulin in colostrum
    Time Frame
    Day 2
    Title
    Colostrum resistin
    Description
    Concentrations of resistin in colostrum
    Time Frame
    Day 2
    Title
    Colostrum adiponectin
    Description
    Concentrations of adiponectin in colostrum
    Time Frame
    Day 2
    Title
    Colostrum microbiota diversity
    Description
    Intra-and Interindividual diversity of colostrum
    Time Frame
    Day 2
    Title
    Presence of the probiotic strain in colostrum
    Description
    Presence of the probiotic strain B. bifidum 900791 in colostrum
    Time Frame
    Day 2
    Title
    Colostrum microbiota composition
    Description
    Relative abundancies of the different bacterial taxa detected by high throughput sequencing
    Time Frame
    Day 2
    Title
    Presence of mastitis
    Description
    Presence of mastitis in the mother during the first month post-partum
    Time Frame
    Days 0-30 pp.
    Title
    Presence of infant colic
    Description
    Appearance of colic in the infant during the first month post-partum
    Time Frame
    Days 0-30 pp.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Women in their last month of pregnancy, who were normal-weight (18.5<BMI<25kg/m2) or who were obese (BMI>30kg/m2) before pregnancy, and their children Women recruited should have expressed their wish to have their child through normal delivery, and to breastfeed at least during the first month post-partum. Exclusion Criteria: Women with chronic diseases (type 2 diabetes, renal diseases, autoimmune diseases, tumor, chronic inflammatory diseases, etc.). Women with a history of digestive surgery. Women whose children are hospitalized more than 24hours in the neonatal unit Women who require antibiotic treatment during the perinatal period.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Martin Gotteland, PhD
    Phone
    56-2-29786977
    Email
    mgottela@med.uchile.cl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carvajal Bielka, RM, MaSc
    Phone
    56-2-29786611
    Email
    bielka.carvajal@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cynthia Barrera, PhD
    Organizational Affiliation
    Univ. of Chile
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Fabien Magne, PhD
    Organizational Affiliation
    University of Chile
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    14657823
    Citation
    Martin R, Langa S, Reviriego C, Jiminez E, Marin ML, Xaus J, Fernandez L, Rodriguez JM. Human milk is a source of lactic acid bacteria for the infant gut. J Pediatr. 2003 Dec;143(6):754-8. doi: 10.1016/j.jpeds.2003.09.028.
    Results Reference
    result
    PubMed Identifier
    27241905
    Citation
    Qian L, Song H, Cai W. Determination of Bifidobacterium and Lactobacillus in breast milk of healthy women by digital PCR. Benef Microbes. 2016 Sep;7(4):559-69. doi: 10.3920/BM2015.0195. Epub 2016 May 31.
    Results Reference
    result
    PubMed Identifier
    18539795
    Citation
    Jimenez E, Fernandez L, Maldonado A, Martin R, Olivares M, Xaus J, Rodriguez JM. Oral administration of Lactobacillus strains isolated from breast milk as an alternative for the treatment of infectious mastitis during lactation. Appl Environ Microbiol. 2008 Aug;74(15):4650-5. doi: 10.1128/AEM.02599-07. Epub 2008 Jun 6.
    Results Reference
    result
    PubMed Identifier
    19525871
    Citation
    Abrahamsson TR, Sinkiewicz G, Jakobsson T, Fredrikson M, Bjorksten B. Probiotic lactobacilli in breast milk and infant stool in relation to oral intake during the first year of life. J Pediatr Gastroenterol Nutr. 2009 Sep;49(3):349-54. doi: 10.1097/MPG.0b013e31818f091b.
    Results Reference
    result
    PubMed Identifier
    22097291
    Citation
    Dubos C, Vega N, Carvallo C, Navarrete P, Cerda C, Brunser O, Gotteland M. Identification of Lactobacillus spp. in colostrum from Chilean mothers. Arch Latinoam Nutr. 2011 Mar;61(1):66-8.
    Results Reference
    result
    PubMed Identifier
    22836031
    Citation
    Cabrera-Rubio R, Collado MC, Laitinen K, Salminen S, Isolauri E, Mira A. The human milk microbiome changes over lactation and is shaped by maternal weight and mode of delivery. Am J Clin Nutr. 2012 Sep;96(3):544-51. doi: 10.3945/ajcn.112.037382. Epub 2012 Jul 25.
    Results Reference
    result
    PubMed Identifier
    29624429
    Citation
    Rautava S. Probiotic Intervention Through the Pregnant and Breastfeeding Mother to Reduce Disease Risk in the Child. Breastfeed Med. 2018 Apr;13(S1):S14-S15. doi: 10.1089/bfm.2018.29076.sjr. No abstract available.
    Results Reference
    result
    PubMed Identifier
    21945174
    Citation
    Luoto R, Laitinen K, Nermes M, Isolauri E. Impact of maternal probiotic-supplemented dietary counseling during pregnancy on colostrum adiponectin concentration: a prospective, randomized, placebo-controlled study. Early Hum Dev. 2012 Jun;88(6):339-44. doi: 10.1016/j.earlhumdev.2011.09.006. Epub 2011 Sep 25.
    Results Reference
    result
    PubMed Identifier
    19302580
    Citation
    Savino F, Fissore MF, Liguori SA, Oggero R. Can hormones contained in mothers' milk account for the beneficial effect of breast-feeding on obesity in children? Clin Endocrinol (Oxf). 2009 Dec;71(6):757-65. doi: 10.1111/j.1365-2265.2009.03585.x. Epub 2009 Mar 19.
    Results Reference
    result
    PubMed Identifier
    27388351
    Citation
    Andreas NJ, Hyde MJ, Herbert BR, Jeffries S, Santhakumaran S, Mandalia S, Holmes E, Modi N. Impact of maternal BMI and sampling strategy on the concentration of leptin, insulin, ghrelin and resistin in breast milk across a single feed: a longitudinal cohort study. BMJ Open. 2016 Jul 7;6(7):e010778. doi: 10.1136/bmjopen-2015-010778.
    Results Reference
    result

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    Impact of B. Bifidum 900791 Intake on Breast Milk Characteristics of Obese Mothers

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