The Effect of Under-nutrition on the Human Microbiota
- Conditions
- Pregnancy
- Registration Number
- NCT02021799
- Lead Sponsor
- Western University, Canada
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 77
- Greater than 12 weeks pregnant
- between the ages of 18 and 40 years
- Less than 12 weeks pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Characterization of gut, oral, vaginal and human milk microbiomes 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 Outcome Measures
Name Time Method Analysis of anthropometric measurements 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.
Assessment of 48-hour Dietary Recalls 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.
Changes in body toxin levels Before and after intervention (approximately 100 days) Body toxin levels (metals, pesticides) by HR-SF-ICP-MS and GC/MS
Changes in blood nutrient levels 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
Related Research Topics
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Trial Locations
- Locations (1)
Nyerere Dispensary
🇹🇿Buswelu, Tanzania
Nyerere Dispensary🇹🇿Buswelu, Tanzania