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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377544
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Naomi Esthernita, Indonesia University

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.


Condition or disease Intervention/treatment Phase
Bifidobacterium Dietary Supplement: Probiotic Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Study Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Placebo Comparator: Placebo
Saccharum lactis
Other: Placebo
Experimental: Probiotic
Bifidobacterium animalis lactis
Dietary Supplement: Probiotic



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377544


Locations
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Indonesia
Budi Kemuliaan Women and Children Hospital
Jakarta, Central Jakarta, Indonesia, 10430
Sponsors and Collaborators
Naomi Esthernita
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Responsible Party: Naomi Esthernita, MD, Indonesia University
ClinicalTrials.gov Identifier: NCT02377544    
Other Study ID Numbers: FKUI-RSCM
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016