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

Bifidobacterium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377544
• Other study ID #: FKUI-RSCM
• Status: Completed
• Phase: N/A
• First received: February 26, 2015
• Last updated: February 24, 2016
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bifidobacterium

Intervention

Dietary Supplement:
• Probiotic

Other:
• Placebo

Locations

Country	Name	City	State
Indonesia	Budi Kemuliaan Women and Children Hospital	Jakarta	Central Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Naomi Esthernita

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal microbiota examination by DNA extraction and real time PCR		3 months	Yes
Primary	Examination of IL-8 in breast milk		3 months	Yes
Primary	Examination of urine IFABP		3 months	Yes
Primary	Calprotectin examination in stool of infants aged 3 months		3 months	Yes
Primary	Alpha 1 antitrypsin		3 months	Yes