Probiotic Supplementation in Breastfed Newborn Infants
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|ClinicalTrials.gov Identifier: NCT02286999|
Recruitment Status : Recruiting
First Posted : November 10, 2014
Last Update Posted : October 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis Food Allergies||Drug: B. infantis Drug: Placebo||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Parallel-group, Randomized, Placebo-controlled Ascending Dose Phase I Study Protocol for Dietary Supplementation With Bifidobacterium Longum Subsp. Infantis (B. Infantis) in Healthy Breastfed Infants|
|Actual Study Start Date :||October 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Infants in the experimental arm will have two doses of the probiotic Bifidobacterium longum subsp. infantis (B. infantis) on Day 7 and Day 14 of life.
Drug: B. infantis
Infants in the intervention group will receive two doses of B. infantis on Day 7 and Day 14 of life, while infants in the placebo group will be dosed with placebo on Day 7 and Day 14
Other Name: Probiotic
Placebo Comparator: Placebo
Infants in the experimental arm will have two doses of placebo (powdered maltodextrin) on Day 7 and Day 14 of life.
- Pharmacologically effective dose (ED) of B. infantis [ Time Frame: Two years ]The primary endpoint of the study is identification of a pharmacologically effective dose of B. infantis required to produce predominant (>50%) gut colonization at six weeks of age
- Safety of Probiotic Supplementation, as assessed by frequency of adverse events [ Time Frame: 2 years ]An additional primary endpoint is to determine the safety of B. infantis supplementation in immunocompetent, full-term infants. Any adverse events including fever 102°F or higher, abdominal pain or colic, blood or pus in the stool, diarrhea or vomiting will be documented and dosing adjusted accordingly
- Milk Oligosaccharide Consumption [ Time Frame: 2 years ]All stool samples will also be analyzed for the presence of oligosaccharides unique to breast milk and for the presence of free saccharide monomers, which are products of their incomplete digestion. B. infantis abundance will be correlated to these values.
- Stool Microbiota Composition [ Time Frame: 2 years ]In addition to determining the percent composition of B. infantis in infant stool samples, numerous other measures such as microbiota diversity and rate of B. infantis decline following cessation of breast feeding will also be determined.
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): NCT02286999
|Contact: Emanual Maverakis, MD||(916) firstname.lastname@example.org|
|Contact: Chelsea Ma, MD||(916) email@example.com|
|United States, California|
|University of California, Davis Department of Dermatology||Recruiting|
|Sacramento, California, United States, 95816|
|Contact: Emanual Maverakis, M.D. 916-734-6556 firstname.lastname@example.org|
|Contact: Hawa Sultani 916-734-6760 email@example.com|
|Principal Investigator: Emanual Maverakis, M.D.|
|Principal Investigator:||Emanual Maverakis, MD||University of California, Davis|