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OpenTrials
Completed

NCT Number: NCT02377544

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

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.

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Key information

Conditions

Bifidobacterium

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Budi Kemuliaan Women and Children Hospital

Jakarta, Central Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

Placebo

Other

Primary outcomes

  1. Gastrointestinal microbiota examination by DNA extraction and real time PCR

    Time frame: 3 months

  2. Examination of IL-8 in breast milk

    Time frame: 3 months

  3. Examination of urine IFABP

    Time frame: 3 months

  4. Calprotectin examination in stool of infants aged 3 months

    Time frame: 3 months

  5. Alpha 1 antitrypsin

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Naomi Esthernita

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 3, 2015
Registry last updated
Feb 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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