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

Not Applicable

Completed

• Conditions: Bifidobacterium
• Interventions: Other: Placebo; Dietary Supplement: Probiotic

• Registration Number: NCT02377544
• Lead Sponsor: Naomi Esthernita

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Saccharum lactis
Probiotic	Probiotic	Bifidobacterium animalis lactis

Primary Outcome Measures

Name	Time	Method
Alpha 1 antitrypsin	3 months
Gastrointestinal microbiota examination by DNA extraction and real time PCR	3 months
Examination of IL-8 in breast milk	3 months
Examination of urine IFABP	3 months
Calprotectin examination in stool of infants aged 3 months	3 months

Trial Locations

Locations (1)

Budi Kemuliaan Women and Children Hospital; 🇮🇩 Jakarta, Central Jakarta, Indonesia