The Effect of Under-nutrition on the Human Microbiota

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021799
• Other study ID #: 102400
• Status: Completed
• Phase: N/A
• First received: July 4, 2013
• Last updated: December 19, 2013
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: December 2013
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Western University Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Greater than 12 weeks pregnant

• between the ages of 18 and 40 years

Exclusion Criteria:

• Less than 12 weeks pregnant

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pregnancy

Intervention

Dietary Supplement:
• Moringa and Lactobacillus rhamnosus GR-1

Locations

Country	Name	City	State
Tanzania	Nyerere Dispensary	Buswelu

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	National Institute for Medical Research, Tanzania

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No