The Effect of Under-nutrition on the Human Microbiota

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Dietary Supplement: Moringa and Lactobacillus rhamnosus GR-1

• 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

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-07-04
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-19
• Last Update Submitted: 2013-12-19
• Study First Posted: 2013-12-27
• Last Update Posted: 2013-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

Inclusion Criteria

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

Exclusion Criteria

• Less than 12 weeks pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Undernourished + Yogurt Pregnant Women	Moringa and Lactobacillus rhamnosus GR-1	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.
Nourished + Yogurt Pregnant Women	Moringa and Lactobacillus rhamnosus GR-1	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.

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

Trial Locations

Locations (1)

Nyerere Dispensary; 🇹🇿 Buswelu, Tanzania