The Effect of Under-nutrition on the Human Microbiota

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Dietary Supplement: Moringa and Lactobacillus rhamnosus GR-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than 12 weeks pregnant between the ages of 18 and 40 years Exclusion Criteria: Less than 12 weeks pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Undernourished Pregnant Women<br>Pregnant women who are classified as undernourished | |
| No Intervention: Nourished Pregnant Women<br>Pregnant women who are classified as healthy | |
| No Intervention: Overweight/obese Pregnant women<br>Pregnant women who are classified as obese or overweight | |
| Experimental: Undernourished + Yogurt Pregnant Women<br>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. | Dietary Supplement: Moringa and Lactobacillus rhamnosus GR-1<br> <br> |
| Experimental: Nourished + Yogurt Pregnant Women<br>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. | Dietary Supplement: Moringa and Lactobacillus rhamnosus GR-1<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut microbiome, Vaginal microbiome, Oral microbiome, Human milk microbiome, Nutritional Status