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

Naomi Esthernita

Status: Completed

Conditions: Bifidobacterium

Treatments: Other: Placebo; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT02377544

FKUI-RSCM

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Saccharum lactis

Treatment:

Other: Placebo

Probiotic

Experimental group

Description:

Bifidobacterium animalis lactis

Treatment:

Dietary Supplement: Probiotic