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The Impact of Vitamin B12 Deficiency on Infant Gut Microbiota

NCT03365583 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2019-03-06

No results posted yet for this study

Summary

Vitamin B12 plays important roles in DNA synthesis and neurological functions. Vitamin B12 deficiency is one of the most common micronutrient deficiencies and it has become increasingly more frequent in infants. The deficiency develops more often between 4 to 12 months of age, coinciding with the decreased fetal storage. The highest rates of vitamin B12 deficiency were observed among infants who are breastfed by mothers receiving a diet low in vitamin B12.

The main objective of this study is to compare the gut microbial composition of healthy term exclusively breastfed infants with or without vitamin B12 deficiency. We hypothesized that gut microbiome differs between vitamin B12 deficient and control infants; pathogenic bacteria are hypothesized to be higher, and beneficial bacteria to be lower in vitamin B12 deficient infants as compared to control.

An observational study in the Marmara University Pendik Research and Training Hospital well child outpatient clinic is conducted in 90 infants. Participants aged between 4 to 6 months who fulfill the inclusion criteria are enrolled.

Inclusion criteria are term birth (\>37 gestational weeks), birth weight \>2500 gr, absence of congenital anomalies, hemoglobin ≥10 g/dL, and exclusive breastfeeding.

Exclusion criteria include prematurity, low birth weight, intrapartum antibiotic use, current or previous use of infant formula, malnutrition, use of iron supplements, infant use of antibiotics, use of probiotics within the last 8 weeks before study entry, and introduction to solid foods.

Primary outcome measures:Microbial counts, and a comparison of type and abundance of species (predominant, pathogenic, and opportunistic bacteria, yeast, and parasites) between vitamin B12 deficient and sufficient subjects will be assessed.

Secondary outcome measures: Fecal bacterial communities will be assessed before and after treatment in a subgroup of infants.

Each stool sample is collected from cloth diapers, and placed in sterile collection tubes. Samples are kept at 4 C and in less than 5 hours, they are frozen at -80 C until further analysis. Specimens are transported on dry ice to the Diagen Inc for DNA extraction.

For the extraction protocol, QuickGene (Kurabo, North America) extraction device will be used.

The extracted DNA samples will be sent to Diversigen Inc (Houston, USA) for analysis. Fecal microbiota composition will be analyzed with 16S ribosomal ribonucleic acid (rRNA) sequencing.

Conditions

  • Vitamin B 12 Deficiency

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Principal Investigators

  • Perran Boran, MD, PhD · Marmara University

Eligibility

Min Age
4 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-03
Primary Completion
2017-09-03
Completion
2017-11-03

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03365583 on ClinicalTrials.gov