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Maternal ObesityNCT03913364

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

A study testing Probiotic in people with Maternal Obesity, run by University of Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Maternal Obesity
What is being tested?
Probiotic
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
No sites listed yet
Study dates
1 Jun 2019to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Martin Gotteland, PhD contact

56-2-29786977

mgottela@med.uchile.cl

Carvajal Bielka, RM, MaSc contact

56-2-29786611

bielka.carvajal@gmail.com

About this study

Official title: 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.

Being tested
Probiotic, Placebo
Keywords
obesity, breast milk, probiotic, IL-6, CRP, Insulin, Adiponectin, Resistin, breastmilk microbiota, Bifidobacterium
Medical subject headings
Pregnancy in Obesity, Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProbioticDietary supplement

    Also called Bifidice

    1. bifidum 900791-containing ice cream

  • PlaceboDietary supplement

    Placebo ice-cream

Study groups in NCT03913364
Study groupRoleWhat they receive
Experimental Obese mothersExperimentalOne 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
Receives: Dietary Supplement: Probiotic
Placebo Obese mothersPlacebo comparatorOne portion (50g) of an ice-cream without probiotic every other day during the last month of gestation and the first month of lactation
Receives: Dietary Supplement: Placebo
Experimental normal weight mothersExperimentalOne 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
Receives: Dietary Supplement: Probiotic
Placebo normal weight mothersPlacebo comparatorOne portion (50g) of an ice-cream without probiotic every other day during the last month of gestation and the first month of lactation
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. C-Reactive Protein concentration in breastmilk

    Concentration of CRP in breastmilk

    Measured: Day-30

Secondary outcomes (9)

  1. IL-6 concentration in breastmilk

    Concentration of IL-6 in breastmilk

    Measured: Day 30

  2. Insulin concentration in breastmilk

    Concentration of Insulin in breastmilk

    Measured: Day 30

  3. Resistin concentration in breastmilk

    Concentration of resistin in breastmilk

    Measured: Day 30

  4. Adiponectin concentration in breastmilk

    Concentration of adiponectin in breastmilk

    Measured: Day 30

  5. Milk microbiota diversity

    Intra-and Interindividual diversity of the milk microbiota

    Measured: Day 30

  6. Milk microbiota composition

    Relative abundancies of the different bacterial taxa detected by high throughput sequencing

    Measured: Day 30

  7. Presence of B. bifidum 900791 in breastmilk

    Presence of the probiotic strain B. bifidum 900791 in breastmilk

    Measured: Day 30

  8. Infant fecal microbiota diversity

    Intra-and Interindividual diversity of the infant fecal microbiota

    Measured: Day 30

  9. Infant fecal microbiota composition

    Relative abundancies of the different bacterial taxa detected by high throughput sequencing

    Measured: Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2019
  2. Study start1 Jun 2019 (estimated)
  3. Primary completion30 Aug 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03913364
Sponsor's protocol ID
UChile-Bifidice-1
Status last verified
May 2019
First submitted
8 Apr 2019
Last updated
30 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 14657823

  • 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.

    PubMed 27241905

  • 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.

    PubMed 18539795

  • 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.

    PubMed 19525871

  • 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.

    PubMed 22097291

  • 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.

    PubMed 22836031

  • 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.

    PubMed 29624429

  • 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.

    PubMed 21945174

  • 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.

    PubMed 19302580

  • 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.

    PubMed 27388351

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic in people with Maternal Obesity, run by University of Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Martin Gotteland, PhD (56-2-29786977, mgottela@med.uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

C-Reactive Protein concentration in breastmilk (time frame: Day-30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03913364, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.

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