The Effect of Under-nutrition on the Human Microbiota

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Dietary supplement: Moringa and Lactobacillus rhamnosus GR-1

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Buswelu, Tanzania
    • Nyerere Dispensary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Less than 12 weeks pregnant

Study Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Undernourished Pregnant Women; Pregnant women who are classified as undernourished
NO_INTERVENTION: Nourished Pregnant Women; Pregnant women who are classified as healthy
NO_INTERVENTION: Overweight/obese Pregnant women; Pregnant women who are classified as obese or overweight
EXPERIMENTAL: Undernourished + Yogurt Pregnant Women; 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
EXPERIMENTAL: Nourished + Yogurt Pregnant Women; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Western University, Canada
• Collaborators: National Institute for Medical Research, Tanzania
• Investigators: Principal Investigator: Gregor Reid, BSc Hons PhD MBA ARM CCM Dr HS, Western University, Canada; Lawson Health Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: July 4, 2013
• First Submitted That Met QC Criteria: December 19, 2013
• First Posted (ESTIMATE): December 27, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 27, 2013
• Last Update Submitted That Met QC Criteria: December 19, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Gut microbiome; Nutritional Status; Oral microbiome; Vaginal microbiome; Human milk microbiome
• Other Study ID Numbers: 102400