The Effect of Under-nutrition on the Human Microbiota

NCT02021799 | Completed

• 1 other identifier: 102400
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Gut microbiome; Vaginal microbiome; Oral microbiome; Human milk microbiome; Nutritional Status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assessment of 48-hour Dietary Recalls

  Monthly on average for four months

• Changes in body toxin levels

  Before and after intervention (approximately 100 days)

• Changes in blood nutrient levels

  before, half-way through and after intervention (approximately 100 days)

• Analysis of anthropometric measurements

  Monthly on average for four months

Other Outcomes (1)

• Analysis of Anthropometric Measurements

  Monthly on Average for 4 months

Study Arms (5)

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.

Dietary Supplement: Moringa and Lactobacillus rhamnosus GR-1

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.

Dietary Supplement: Moringa and Lactobacillus rhamnosus GR-1

Interventions

Moringa and Lactobacillus rhamnosus GR-1 DIETARY_SUPPLEMENT

Nourished + Yogurt Pregnant Women; Undernourished + Yogurt Pregnant Women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Less than 12 weeks pregnant

Sponsors & Collaborators

• Western University, Canada: lead
• National Institute for Medical Research, Tanzania: collaborator

Study Sites (1)

Nyerere Dispensary

Buswelu, Tanzania

Location

Related Publications (1)

• 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.

  PMID: 25293764 DERIVED

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2013
• First Posted: December 27, 2013
• Study Start: August 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 27, 2013

Record last verified: 2013-12

Locations

TA (1)