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

Maternal Obesity Clinical Trial

Official title:

Evaluation of B. Bifidum 900791 as a Modulator of Microbiota, Inflammatory Mediators and Metabolic Hormones in Breast Milk From Obese Mothers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03913364
• Other study ID #: UChile-Bifidice-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2019
• Source: University of Chile
• Contact: Martin Gotteland, PhD
• Phone: 56-2-29786977
• Email: mgottela[@]med.uchile.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 31, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Maternal Obesity

Intervention

Dietary Supplement:
• Probiotic
B. bifidum 900791-containing ice cream
• Placebo
Placebo ice-cream

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

References & Publications (10)

Abrahamsson TR, Sinkiewicz G, Jakobsson T, Fredrikson M, Björkstén 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.0b — View 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 coho — View 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 — View 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. — View Citation

Jiménez E, Fernández L, Maldonado A, Martín R, Olivares M, Xaus J, Rodríguez JM. Oral administration of Lactobacillus strains isolated from breast milk as an alternative for the treatment of infectious mastitis during lactation. Appl Environ Microbiol. 20 — View 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 — View Citation

Martín R, Langa S, Reviriego C, Jimínez E, Marín ML, Xaus J, Fernández L, Rodríguez JM. Human milk is a source of lactic acid bacteria for the infant gut. J Pediatr. 2003 Dec;143(6):754-8. — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Colostrum IL-6	Concentrations of IL-6 in colostrum	Day 2
Other	Colostrum CRP	Concentrations of CRP in colostrum	Day 2
Other	Colostrum insulin	Concentrations of insulin in colostrum	Day 2
Other	Colostrum resistin	Concentrations of resistin in colostrum	Day 2
Other	Colostrum adiponectin	Concentrations of adiponectin in colostrum	Day 2
Other	Colostrum microbiota diversity	Intra-and Interindividual diversity of colostrum	Day 2
Other	Presence of the probiotic strain in colostrum	Presence of the probiotic strain B. bifidum 900791 in colostrum	Day 2
Other	Colostrum microbiota composition	Relative abundancies of the different bacterial taxa detected by high throughput sequencing	Day 2
Other	Presence of mastitis	Presence of mastitis in the mother during the first month post-partum	Days 0-30 pp.
Other	Presence of infant colic	Appearance of colic in the infant during the first month post-partum	Days 0-30 pp.
Primary	C-Reactive Protein concentration in breastmilk	Concentration of CRP in breastmilk	Day-30
Secondary	IL-6 concentration in breastmilk	Concentration of IL-6 in breastmilk	Day 30
Secondary	Insulin concentration in breastmilk	Concentration of Insulin in breastmilk	Day 30
Secondary	Resistin concentration in breastmilk	Concentration of resistin in breastmilk	Day 30
Secondary	Adiponectin concentration in breastmilk	Concentration of adiponectin in breastmilk	Day 30
Secondary	Milk microbiota diversity	Intra-and Interindividual diversity of the milk microbiota	Day 30
Secondary	Milk microbiota composition	Relative abundancies of the different bacterial taxa detected by high throughput sequencing	Day 30
Secondary	Presence of B. bifidum 900791 in breastmilk	Presence of the probiotic strain B. bifidum 900791 in breastmilk	Day 30
Secondary	Infant fecal microbiota diversity	Intra-and Interindividual diversity of the infant fecal microbiota	Day 30
Secondary	Infant fecal microbiota composition	Relative abundancies of the different bacterial taxa detected by high throughput sequencing	Day 30