Clinical trial NCT02457338: Infant Microbiota and Probiotic Intake Study
Official title: Infant Supplementation With Probiotic Bifidobacterium Longum Subsp. Infantis Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: C-section
Infants
Probiotic
B. infantis
Microbiota
Gut
Breast milk
Vaginal
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Evolve BioSystems, Inc.
First posted: 2015-05-29
Enrollment: 120
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if supplementing healthy term infants delivered by C-section or vaginal delivery who only consume breastmilk with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool.

Detailed description: The purpose of this clinical trial is to determine the effects of supplementing the probiotic Bifidobacterium longum subsp. infantis for the first 21 days of life in healthy term breastfed infants delivered via C-section or vaginal delivery on gut bacteria composition during, 1 week, and 1 month after supplementation compared with matched-control term infants receiving standard care. The investigators' specific aim is to compare the fecal microbiota (total B. infantis, total Bifidobacterium, total bacteria and composition of microbiota) between the supplement and control groups.

Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking women and their infants
* Who are pregnant in their third trimester OR have delivered by C-section or vaginal birth within the past 7 days
* Patients who live within a 20-mile radius from University of California Davis Medical Center (UCDMC) or a 20-mile radius from UC Davis Campus in Davis, California.
* Plan to exclusively breastfeed their infants for at least 3 months
* Infants: 0-7 days old, delivered by C-section or vaginal delivery, born \>37 weeks gestation, without medical complications that would preclude breastfeeding or alter gut microbiota

Exclusion Criteria:

* Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
* Infants who have taken antibiotics for more than 72 hours of life
* Infants who have consume formula feedings after day 7 of life
* Mothers and their infants who are not discharged from the hospital by day 4 of life due to complications
* Plan to administer probiotics to infants or use of probiotics other than the study supplement by infants anytime throughout the study duration
* Women who have had any breast surgery or injury within the past 5 years that would reduce the chance of successful exclusive breastfeeding
* Mothers who have a chronic metabolic disease or obesity

Primary outcomes:
measure: Infant fecal B. infantis
timeFrame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
measure: Infant fecal Bifidobacterium
timeFrame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
measure: Infant fecal total bacteria
timeFrame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
measure: Infant fecal microbiota
timeFrame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
measure: Incidence of Adverse Events and Treatments
timeFrame: Baseline-days 60
measure: Incidence of Adverse Events and Treatments
timeFrame: Months 4, 6, 8, 10, 12, 18 and 24
Secondary outcomes:
measure: Infant fecal bacteria oligosaccharide consumption
timeFrame: days 7, 14, 21, 32, 60
measure: Infant fecal sialic acid concentrations
timeFrame: baseline, days 10, 14, 17, 21, 25, 29, 32, 40, 50, 60
measure: Maternal fecal B. infantis, Bifidobacterium, total bacteria, and microbiota composition
timeFrame: baseline, day 60
measure: Infant weight
timeFrame: birth, hospital discharge, days 15, 33, 61
measure: Fecal inflammatory mediators
timeFrame: Baseline-days 60
measure: Fecal gut barrier function barrier markers
timeFrame: Baseline-days 60
measure: Fecal lipopolysaccharide
timeFrame: Baseline-days 60
measure: Fecal short-chain fatty acids
timeFrame: Baseline-days 60
measure: Fecal microbiome-Follow-up
timeFrame: Months 4, 6, 8, 10, 12
measure: Fecal B. infantis-Follow-up
timeFrame: Months 4, 6, 8, 10, 12
measure: Fecal Bifidobacterium-Follow-up
timeFrame: Months 4, 6, 8, 10, 12
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Jennifer Smilowitz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Mark Underwood, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Smilowitz JT, Moya J, Breck MA, Cook C, Fineberg A, Angkustsiri K, Underwood MA. Erratum to: Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: a phase I clinical trial. BMC Pediatr. 2017 Aug 15;17(1):180. doi: 10.1186/s12887-017-0932-7. No abstract available.
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citation: Smilowitz JT, Moya J, Breck MA, Cook C, Fineberg A, Angkustsiri K, Underwood MA. Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: a phase I clinical trial. BMC Pediatr. 2017 May 30;17(1):133. doi: 10.1186/s12887-017-0886-9.