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The Effect of Under-nutrition on the Human Microbiota

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ClinicalTrials.gov Identifier: NCT02021799
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : December 27, 2013
Sponsor:
Collaborator:
National Institute for Medical Research, Tanzania
Information provided by (Responsible Party):
Dr. Gregor Reid, Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Pregnancy Dietary Supplement: Moringa and Lactobacillus rhamnosus GR-1 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Effect of Nutrition on the Microbiome in Pregnant Women and the Use of Micronutrient Supplemented Probiotic Yogurt to Improve Outcomes
Study Start Date : August 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

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



Primary Outcome Measures :
  1. Characterization of gut, oral, vaginal and human milk microbiomes [ Time Frame: 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 Outcome Measures :
  1. Assessment of 48-hour Dietary Recalls [ Time Frame: 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.

  2. Changes in body toxin levels [ Time Frame: Before and after intervention (approximately 100 days) ]
    Body toxin levels (metals, pesticides) by HR-SF-ICP-MS and GC/MS

  3. Changes in blood nutrient levels [ Time Frame: 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

  4. Analysis of anthropometric measurements [ Time Frame: 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 Outcome Measures:
  1. Analysis of Anthropometric Measurements [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Less than 12 weeks pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021799


Locations
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Tanzania
Nyerere Dispensary
Buswelu, Tanzania
Sponsors and Collaborators
Western University, Canada
National Institute for Medical Research, Tanzania
Investigators
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Principal Investigator: Gregor Reid, BSc Hons PhD MBA ARM CCM Dr HS Western University, Canada; Lawson Health Research Institute
Principal Investigator: Jeremy P Burton, Phd Lawson Health Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Gregor Reid, Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT02021799    
Other Study ID Numbers: 102400
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: December 27, 2013
Last Verified: December 2013
Keywords provided by Dr. Gregor Reid, Western University, Canada:
Gut microbiome
Vaginal microbiome
Oral microbiome
Human milk microbiome
Nutritional Status