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Completed

NCT Number: NCT02021799

The Effect of Under-nutrition on the Human Microbiota

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.

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Key information

Conditions

Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nyerere Dispensary

Buswelu, Tanzania

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Less than 12 weeks pregnant

Treatment and study plan

Moringa and Lactobacillus rhamnosus GR-1

Dietary Supplement

Primary outcomes

  1. 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

  1. Assessment of 48-hour Dietary Recalls

    Time frame: Monthly on average for four months

    Dietary recalls will be assessed for average daily caloric, protein, carbohydrate, fat, calcium, iron, zinc, folate and vitamin intake using ESHA Food Processor SQL software.

  2. Changes in body toxin levels

    Time frame: Before and after intervention (approximately 100 days)

    Body toxin levels (metals, pesticides) by HR-SF-ICP-MS and GC/MS

  3. Changes in blood nutrient levels

    Time frame: before, half-way through and after intervention (approximately 100 days)

    Blood nutrient levels (vitamins, macro and micr-nutrients) will be assessed by HPLC, colorimetric Biuret, chemiluminescence and HR-SF-ICP-MS

  4. Analysis of anthropometric measurements

    Time frame: Monthly on average for four months

    Changes in weight gain, mid-upper arm circumference and hemoglobin levels will be examined and changes will be linked to intervention and non-intervention via statistical analysis.

Other outcomes

  1. Analysis of Anthropometric Measurements

    Time frame: Monthly on Average for 4 months

    Change in the weight gain, mid-upper arm circumference and hemoglobin measurements will be analyzed over the course of study.

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Collaborators

  • National Institute for Medical Research, Tanzania

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 27, 2013
Registry last updated
Dec 27, 2013

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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