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Clinical Trials/NCT02021799
NCT02021799
Completed
Not Applicable

The Effect of Nutrition on the Microbiome in Pregnant Women and the Use of Micronutrient Supplemented Probiotic Yogurt to Improve Outcomes

Western University, Canada1 site in 1 country77 target enrollmentAugust 2012
ConditionsPregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Western University, Canada
Enrollment
77
Locations
1
Primary Endpoint
Characterization of gut, oral, vaginal and human milk microbiomes
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The purpose of this study is to determine whether a difference exists in the gut, oral, vaginal and human milk microbiome of under-nourished pregnant women as compared to healthy and obese pregnant women. In addition, the investigators are setting out to determine if a micronutrient enriched probiotic yogurt can improve the microbiome and pregnancy outcomes of under-nourished pregnant women.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
April 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Western University, Canada
Responsible Party
Principal Investigator
Principal Investigator

Dr. Gregor Reid

Professor

Western University, Canada

Eligibility Criteria

Inclusion Criteria

  • Greater than 12 weeks pregnant
  • between the ages of 18 and 40 years

Exclusion Criteria

  • Less than 12 weeks pregnant

Outcomes

Primary Outcomes

Characterization of gut, oral, vaginal and human milk microbiomes

Time Frame: Monthly for an average of four months

Fecal, oral and vaginal samples were collected on a monthly basis for an average of four months. Human milk samples were collected twice; at birth and one week after. Microbial DNA will be extracted with the MoBio PowerSoil 96-well htp kit. Samples will be sequenced and changes determined by 16s rRNA profiling.

Secondary Outcomes

  • Analysis of anthropometric measurements(Monthly on average for four months)
  • Assessment of 48-hour Dietary Recalls(Monthly on average for four months)
  • Changes in body toxin levels(Before and after intervention (approximately 100 days))
  • Changes in blood nutrient levels(before, half-way through and after intervention (approximately 100 days))

Study Sites (1)

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