The Impact of Vitamin B12 Deficiency on Infant Gut Microbiota

NCT03365583 | Completed

• 1 other identifier: 09.2016.137
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vitamin B12; Microbiome; infant

Outcome Measures

Primary Outcomes (1)

• Gut microbial community differences between infants with vitamin B12 deficiency and infants with sufficient vitamin B12

  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

  DNA extraction and fecal microbiota composition with 16S rRNA sequencing is anticipated to be completed at June 2018

Secondary Outcomes (1)

• Gut microbial community differences within subject

  Recollection of stool samples one month after treatment as usual. DNA extraction and fecal microbiota composition with 16S rRNA sequencing is anticipated to be completed at June 2018

Study Arms (2)

Vitamin B12 deficiency

No intervention will be administered for this study. Serum vitamin B12 \<203 pg/mL is considered as vitamin B12 deficiency. Fecal microbiota composition will be analyzed with 16S rRNA sequencing. In a subgroup of infants (n=11), fecal samples will be recollected after the treatment as usual

Vitamin B12 sufficient

Serum vitamin B12 ≥203 pg/mL is considered as vitamin B12 sufficient Fecal microbiota composition will be analyzed with 16S rRNA sequencing.

Eligibility Criteria

• Age: 4 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Healthy term exclusively breastfed infants aged between 4 to 6 months who fulfill the inclusion criteria are enrolled

You may qualify if:

• must be \>37 gestational weeks, birth weight must be \>2500 gr, must be exclusively breastfed there should be no congenital anomalies, hemoglobin should be ≥10 g/dL,

You may not qualify if:

• prematurity, low birth weight, intrapartum antibiotic use, current or previous use of infant formula, malnutrition, use of iron supplements, use of antibiotics, use of probiotics within the last 8 weeks before study entry, and being introduced to solid foods

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples of breastfed infants will be extracted for DNA

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Perran Boran, MD, PhD

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2017
• First Posted: December 7, 2017
• Study Start: March 3, 2017
• Primary Completion: September 3, 2017
• Study Completion: November 3, 2017
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

TU (1)