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| Name | Class |
|---|---|
| National Institute for Medical Research, Tanzania | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Undernourished Pregnant Women | No Intervention | Pregnant women who are classified as undernourished | |
| Nourished Pregnant Women | No Intervention | Pregnant women who are classified as healthy | |
| Overweight/obese Pregnant women | No Intervention | Pregnant women who are classified as obese or overweight | |
| Undernourished + Yogurt Pregnant Women | Experimental | Pregnant women who are undernourished and selected to receive Moringa and Lactobacillus rhamnosus GR-1 probiotic yogurt. Yogurt contained 4.3 grams of Moringa and 10^8 CFU/mL of Lactobacillus rhamnosus GR-1 as well as Streptococcus thermophilus and Lactobacillus bulgaricus starter cultures. |
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| Nourished + Yogurt Pregnant Women | Experimental | Pregnant women who are healthy and selected to receive Moringa and Lactobacillus rhamnosus GR-1 probiotic yogurt. Yogurt contained 4.3 grams of Moringa and 10^8 CFU/mL of Lactobacillus rhamnosus GR-1 as well as Streptococcus thermophilus and Lactobacillus bulgaricus starter cultures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moringa and Lactobacillus rhamnosus GR-1 | Dietary Supplement |
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| Measure | Description | Time Frame |
|---|---|---|
| Characterization of gut, oral, vaginal and human milk microbiomes | 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. | Monthly for an average of four months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of 48-hour Dietary Recalls | 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. | Monthly on average for four months |
| Changes in body toxin levels |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of Anthropometric Measurements | Change in the weight gain, mid-upper arm circumference and hemoglobin measurements will be analyzed over the course of study. | Monthly on Average for 4 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregor Reid, BSc Hons PhD MBA ARM CCM Dr HS | Western University, Canada; Lawson Health Research Institute | Principal Investigator |
| Jeremy P Burton, Phd | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nyerere Dispensary | Buswelu | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25293764 | Derived | Bisanz JE, Enos MK, Mwanga JR, Changalucha J, Burton JP, Gloor GB, Reid G. Randomized open-label pilot study of the influence of probiotics and the gut microbiome on toxic metal levels in Tanzanian pregnant women and school children. mBio. 2014 Oct 7;5(5):e01580-14. doi: 10.1128/mBio.01580-14. |
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Body toxin levels (metals, pesticides) by HR-SF-ICP-MS and GC/MS |
| Before and after intervention (approximately 100 days) |
| Changes in blood nutrient levels | Blood nutrient levels (vitamins, macro and micr-nutrients) will be assessed by HPLC, colorimetric Biuret, chemiluminescence and HR-SF-ICP-MS | before, half-way through and after intervention (approximately 100 days) |
| Analysis of anthropometric measurements | 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. | Monthly on average for four months |