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Probiotic Supplementation in Breastfed Newborn Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02286999
Recruitment Status : Recruiting
First Posted : November 10, 2014
Last Update Posted : October 30, 2017
Information provided by (Responsible Party):
Emanual Maverakis, MD, University of California, Davis

Brief Summary:
The purpose of this study is to investigate the dose of a probiotic supplement (Bifidobacterium longum subsp. infantis) required to achieve predominant gut colonization in healthy newborn, breastfed infants. The study will also examine whether supplementation with this probiotic can reduce the chance of developing eczema and food allergies in enrolled infants.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Food Allergies Drug: B. infantis Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: B.infantis
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.
Drug: Placebo

Primary Outcome Measures :
  1. 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

  2. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy newborn infants between 1 and 7 days old with intent to be exclusively breastfed for a minimum of six (6) months

Exclusion Criteria:

  • Infants given dietary supplementation, including other probiotics.
  • Infants born prior to 34 weeks gestation.
  • Infants below 10th percentile for body weight.
  • Postnatal use of antibiotics (oral, intramuscular or intravenous) by either the mother or the infant. Of note, prenatal maternal Group B streptococcus prophylaxis is not a criterion for study exclusion.
  • Family history of immunodeficiency syndrome(s).
  • Infants with signs of a clinically apparent underlying immunodeficiency.
  • Intent to use non-breast milk infant formula for feeding during the first six months.
  • History of GI tract abnormality or infection.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02286999

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Contact: Emanual Maverakis, MD (916) 734-1512
Contact: Chelsea Ma, MD (916) 734-6760

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United States, California
University of California, Davis Department of Dermatology Recruiting
Sacramento, California, United States, 95816
Contact: Emanual Maverakis, M.D.    916-734-6556   
Contact: Hawa Sultani    916-734-6760   
Principal Investigator: Emanual Maverakis, M.D.         
Sponsors and Collaborators
Emanual Maverakis, MD
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Principal Investigator: Emanual Maverakis, MD University of California, Davis

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Emanual Maverakis, MD, Principal Investigator, University of California, Davis Identifier: NCT02286999     History of Changes
Other Study ID Numbers: 651698
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dermatitis, Atopic
Food Hypersensitivity
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases