Impact of B. Bifidum 900791 Intake on Breast Milk Characteristics of Obese Mothers
May 28, 2019 updated by: Martin Gotteland, University of Chile
Evaluation of B. Bifidum 900791 as a Modulator of Microbiota, Inflammatory Mediators and Metabolic Hormones in Breast Milk From Obese Mothers
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Experimental Obese mothers
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
|
B. bifidum 900791-containing ice cream
Other Names:
|
|
PLACEBO_COMPARATOR: Placebo Obese mothers
One portion (50g) of an ice-cream without probiotic every other day during the last month of gestation and the first month of lactation
|
Placebo ice-cream
|
|
EXPERIMENTAL: Experimental normal weight mothers
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
|
B. bifidum 900791-containing ice cream
Other Names:
|
|
PLACEBO_COMPARATOR: Placebo normal weight mothers
One portion (50g) of an ice-cream without probiotic every other day during the last month of gestation and the first month of lactation
|
Placebo ice-cream
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
C-Reactive Protein concentration in breastmilk
Time Frame: Day-30
|
Concentration of CRP in breastmilk
|
Day-30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IL-6 concentration in breastmilk
Time Frame: Day 30
|
Concentration of IL-6 in breastmilk
|
Day 30
|
|
Insulin concentration in breastmilk
Time Frame: Day 30
|
Concentration of Insulin in breastmilk
|
Day 30
|
|
Resistin concentration in breastmilk
Time Frame: Day 30
|
Concentration of resistin in breastmilk
|
Day 30
|
|
Adiponectin concentration in breastmilk
Time Frame: Day 30
|
Concentration of adiponectin in breastmilk
|
Day 30
|
|
Milk microbiota diversity
Time Frame: Day 30
|
Intra-and Interindividual diversity of the milk microbiota
|
Day 30
|
|
Milk microbiota composition
Time Frame: Day 30
|
Relative abundancies of the different bacterial taxa detected by high throughput sequencing
|
Day 30
|
|
Presence of B. bifidum 900791 in breastmilk
Time Frame: Day 30
|
Presence of the probiotic strain B. bifidum 900791 in breastmilk
|
Day 30
|
|
Infant fecal microbiota diversity
Time Frame: Day 30
|
Intra-and Interindividual diversity of the infant fecal microbiota
|
Day 30
|
|
Infant fecal microbiota composition
Time Frame: Day 30
|
Relative abundancies of the different bacterial taxa detected by high throughput sequencing
|
Day 30
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Colostrum IL-6
Time Frame: Day 2
|
Concentrations of IL-6 in colostrum
|
Day 2
|
|
Colostrum CRP
Time Frame: Day 2
|
Concentrations of CRP in colostrum
|
Day 2
|
|
Colostrum insulin
Time Frame: Day 2
|
Concentrations of insulin in colostrum
|
Day 2
|
|
Colostrum resistin
Time Frame: Day 2
|
Concentrations of resistin in colostrum
|
Day 2
|
|
Colostrum adiponectin
Time Frame: Day 2
|
Concentrations of adiponectin in colostrum
|
Day 2
|
|
Colostrum microbiota diversity
Time Frame: Day 2
|
Intra-and Interindividual diversity of colostrum
|
Day 2
|
|
Presence of the probiotic strain in colostrum
Time Frame: Day 2
|
Presence of the probiotic strain B. bifidum 900791 in colostrum
|
Day 2
|
|
Colostrum microbiota composition
Time Frame: Day 2
|
Relative abundancies of the different bacterial taxa detected by high throughput sequencing
|
Day 2
|
|
Presence of mastitis
Time Frame: Days 0-30 pp.
|
Presence of mastitis in the mother during the first month post-partum
|
Days 0-30 pp.
|
|
Presence of infant colic
Time Frame: Days 0-30 pp.
|
Appearance of colic in the infant during the first month post-partum
|
Days 0-30 pp.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cynthia Barrera, PhD, Univ. of Chile
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
June 1, 2019
Primary Completion (ANTICIPATED)
August 30, 2019
Study Completion (ANTICIPATED)
December 31, 2019
Study Registration Dates
First Submitted
April 8, 2019
First Submitted That Met QC Criteria
April 10, 2019
First Posted (ACTUAL)
April 12, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 30, 2019
Last Update Submitted That Met QC Criteria
May 28, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UChile-Bifidice-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.