NCT02377544

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

February 26, 2015

Last Update Submit

February 24, 2016

Conditions

Bifidobacterium

Outcome Measures

Primary Outcomes (5)

  • 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

  • Alpha 1 antitrypsin

    3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Saccharum lactis

Other: Placebo

Probiotic

EXPERIMENTAL

Bifidobacterium animalis lactis

Dietary Supplement: Probiotic

Interventions

ProbioticDIETARY_SUPPLEMENT
Probiotic
PlaceboOTHER
Placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Budi Kemuliaan Women and Children Hospital

Jakarta, Central Jakarta, 10430, Indonesia

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 3, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 25, 2016

Record last verified: 2016-02

Locations

ID(1)