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The Role of Bifidobacterium Animalis Ssp Lactis DR10 Supplementation in Women During Pregnancy and Lactation on Breast Milk IL-8 and Gut Mucosa Integrity in Infant

The Role of Bifidobacterium Animalis Ssp Lactis DR10 Supplementation in Women During Pregnancy and Lactation on Breast Milk IL-8 and Gut Mucosa Integrity in Infant

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02377544
Enrollment
70
Registered
2015-03-03
Start date
2014-12-31
Completion date
2015-12-31
Last updated
2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bifidobacterium

Brief summary

Hopefully this research can help to provide the optimal nutrition management from pregnancy so that the babies wiil born with better quality of health and reduce the morbidity and mortality. Until now, there is no data regarding probiotics in Indonesien breastmilk and the role of probiotics supplementation on pregnant women to the baby especially from inflammation pathways. The investigators hope the result of this research can help reducing infant morbidity and mortality rate in Indonesia, also has a benefit for future research.

Interventions

DIETARY_SUPPLEMENTProbiotic
OTHERPlacebo

Sponsors

Naomi Esthernita
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* pregnant women ,gestation age 32-34 weeks, normal pregnancy, plan to deliver spontaneously, no antibiotic * tend to give exclusive breastfeeding * want to join the research * well doing baby

Exclusion criteria

* pregnant women with pre-eclampsia,bleeding,infection,premature rupture of the membrane or other chronic disease * plan to deliver by caesarean section

Design outcomes

Primary

MeasureTime frame
Gastrointestinal microbiota examination by DNA extraction and real time PCR3 months
Examination of IL-8 in breast milk3 months
Examination of urine IFABP3 months
Calprotectin examination in stool of infants aged 3 months3 months
Alpha 1 antitrypsin3 months

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026