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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | B. bifidum 900791-containing ice cream |
|
| Measure | Description | Time Frame |
|---|---|---|
| C-Reactive Protein concentration in breastmilk | Concentration of CRP in breastmilk | Day-30 |
| Measure | Description | Time Frame |
|---|---|---|
| IL-6 concentration in breastmilk | Concentration of IL-6 in breastmilk | Day 30 |
| Insulin concentration in breastmilk | Concentration of Insulin in breastmilk |
| Measure | Description | Time Frame |
|---|---|---|
| Colostrum IL-6 | Concentrations of IL-6 in colostrum | Day 2 |
| Colostrum CRP | Concentrations of CRP in colostrum | Day 2 |
Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Gotteland, PhD | Contact | 56-2-29786977 | mgottela@med.uchile.cl | |
| Carvajal Bielka, RM, MaSc | Contact | 56-2-29786611 | bielka.carvajal@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Cynthia Barrera, PhD | Univ. of Chile | Principal Investigator |
| Fabien Magne, PhD | University of Chile | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14657823 | Result | 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. | |
| 27241905 | 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. |
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| ID | Term |
|---|---|
| D000079262 | Pregnancy in Obesity |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D050177 | Overweight |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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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.
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| Placebo | Dietary Supplement | Placebo ice-cream |
|
| Day 30 |
| Resistin concentration in breastmilk | Concentration of resistin in breastmilk | Day 30 |
| Adiponectin concentration in breastmilk | Concentration of adiponectin in breastmilk | Day 30 |
| Milk microbiota diversity | Intra-and Interindividual diversity of the milk microbiota | Day 30 |
| Milk microbiota composition | Relative abundancies of the different bacterial taxa detected by high throughput sequencing | Day 30 |
| Presence of B. bifidum 900791 in breastmilk | Presence of the probiotic strain B. bifidum 900791 in breastmilk | Day 30 |
| Infant fecal microbiota diversity | Intra-and Interindividual diversity of the infant fecal microbiota | Day 30 |
| Infant fecal microbiota composition | Relative abundancies of the different bacterial taxa detected by high throughput sequencing | Day 30 |
| Colostrum insulin | Concentrations of insulin in colostrum | Day 2 |
| Colostrum resistin | Concentrations of resistin in colostrum | Day 2 |
| Colostrum adiponectin | Concentrations of adiponectin in colostrum | Day 2 |
| Colostrum microbiota diversity | Intra-and Interindividual diversity of colostrum | Day 2 |
| Presence of the probiotic strain in colostrum | Presence of the probiotic strain B. bifidum 900791 in colostrum | Day 2 |
| Colostrum microbiota composition | Relative abundancies of the different bacterial taxa detected by high throughput sequencing | Day 2 |
| Presence of mastitis | Presence of mastitis in the mother during the first month post-partum | Days 0-30 pp. |
| Presence of infant colic | Appearance of colic in the infant during the first month post-partum | Days 0-30 pp. |
| 18539795 | 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. |
| 19525871 | 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. |
| 22097291 | 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. |
| 22836031 | 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. |
| 29624429 | 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. |
| 21945174 | 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. |
| 19302580 | 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. |
| 27388351 | 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. |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D019602 |
| Food and Beverages |