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The Effect of Under-nutrition on the Human Microbiota

NCT ID: NCT02021799

Last Updated: 2013-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-04-30

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.

Detailed Description

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Conditions

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Pregnancy

Keywords

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Gut microbiome Vaginal microbiome Oral microbiome Human milk microbiome Nutritional Status

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Undernourished Pregnant Women

Pregnant women who are classified as undernourished

Group Type NO_INTERVENTION

No interventions assigned to this group

Nourished Pregnant Women

Pregnant women who are classified as healthy

Group Type NO_INTERVENTION

No interventions assigned to this group

Overweight/obese Pregnant women

Pregnant women who are classified as obese or overweight

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Moringa and Lactobacillus rhamnosus GR-1

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type EXPERIMENTAL

Moringa and Lactobacillus rhamnosus GR-1

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Moringa and Lactobacillus rhamnosus GR-1

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Medical Research, Tanzania

OTHER_GOV

Sponsor Role collaborator

Western University, Canada

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gregor Reid

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregor Reid, BSc Hons PhD MBA ARM CCM Dr HS

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada; Lawson Health Research Institute

Jeremy P Burton, Phd

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

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Nyerere Dispensary

Buswelu, , Tanzania

Site Status

Countries

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Tanzania

References

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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.

Reference Type DERIVED
PMID: 25293764 (View on PubMed)

Other Identifiers

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102400

Identifier Type: -

Identifier Source: org_study_id