Trials / Active Not Recruiting
Active Not RecruitingNCT02457338
Infant Microbiota and Probiotic Intake Study
Infant Supplementation With Probiotic Bifidobacterium Longum Subsp. Infantis Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- University of California, Davis · Academic / Other
- Sex
- Female
- Age
- 21 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Bifidobacterium |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2016-07-15
- Completion
- 2027-06-07
- First posted
- 2015-05-29
- Last updated
- 2025-12-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02457338. Inclusion in this directory is not an endorsement.