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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02021799

Enrollment

Registered

2013-12-27

Start date

2012-08-31

Completion date

2013-04-30

Last updated

2013-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTMoringa and Lactobacillus rhamnosus GR-1

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Less than 12 weeks pregnant

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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.

Other

Measure	Time frame	Description
Analysis of Anthropometric Measurements	Monthly on Average for 4 months	Change in the weight gain, mid-upper arm circumference and hemoglobin measurements will be analyzed over the course of study.

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026