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

NCT03913364 | Unknown

• 1 other identifier: UChile-Bifidice-1
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Maternal Obesity

Keywords

obesity; breast milk; probiotic; IL-6; CRP; Insulin; Adiponectin; Resistin; breastmilk microbiota; Bifidobacterium

Outcome Measures

Primary Outcomes (1)

• C-Reactive Protein concentration in breastmilk

  Concentration of CRP in breastmilk

  Day-30

Secondary Outcomes (9)

• IL-6 concentration in breastmilk

  Day 30

• Insulin concentration in breastmilk

  Day 30

• Resistin concentration in breastmilk

  Day 30

• Adiponectin concentration in breastmilk

  Day 30

• Milk microbiota diversity

  Day 30

Other Outcomes (10)

• Colostrum IL-6

  Day 2

• Colostrum CRP

  Day 2

• Colostrum insulin

  Day 2

Study Arms (4)

Experimental Obese mothers

EXPERIMENTAL

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

Dietary Supplement: Probiotic

Placebo Obese mothers

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Experimental normal weight mothers

EXPERIMENTAL

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

Dietary Supplement: Probiotic

Placebo normal weight mothers

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

B. bifidum 900791-containing ice cream

Also known as: Bifidice

Experimental Obese mothers; Experimental normal weight mothers

Placebo DIETARY_SUPPLEMENT

Placebo ice-cream

Placebo Obese mothers; Placebo normal weight mothers

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead

Related Publications (10)

• 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.

  PMID: 14657823 RESULT

• 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.

  PMID: 27241905 RESULT

• 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.

  PMID: 18539795 RESULT

• 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.

  PMID: 19525871 RESULT

• 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.

  PMID: 22097291 RESULT

• 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.

  PMID: 22836031 RESULT

• 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.

  PMID: 29624429 RESULT

• 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.

  PMID: 21945174 RESULT

• 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.

  PMID: 19302580 RESULT

• 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.

  PMID: 27388351 RESULT

MeSH Terms

Conditions

Pregnancy in Obesity; Obesity; Insulin Resistance

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Cynthia Barrera, PhD

  Univ. of Chile

  PRINCIPAL INVESTIGATOR

• Fabien Magne, PhD

  University of Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Gotteland, PhD

CONTACT

56-2-29786977; mgottela@med.uchile.cl

Carvajal Bielka, RM, MaSc

CONTACT

56-2-29786611; bielka.carvajal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Lab. of Digestive physiology

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 12, 2019
• Study Start: June 1, 2019
• Primary Completion: August 30, 2019
• Study Completion: December 31, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share