Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
NA
Study Classification
INTERVENTIONAL
Study Start Date
2017-05-15
Study Completion Date
2017-05-16
Brief Summary
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The purpose of this study is to determine if supplementing healthy term infants delivered vaginally who consume breast milk, formula, or both with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool.
Detailed Description
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The purpose of phase 1 of this two phase clinical trial is to determine: 1) the effect of decreasing levels of human milk oligosaccharides on fecal B.infantis during and after 21 days of supplementation with Evolve activated B.infantis using exclusively breastfed, mixed-fed and exclusively formula-fed infants; 2) determine the effect of Evolve activated B.infantis on fecal B.infantis levels in exclusively breastfed infants compared to pre-supplementation levels.
Conditions
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Microbial Colonization
Keywords
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Infants
Probiotic
B. Infantis
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
The feeding patterns of eighty eligible infants (8 to 12 weeks in age) will be characterized based on a 7-day diet record that will be filled out by their mothers during the 7-day lead-in period starting with Day -7 and ending with Day -1. Of the eighty infants, twenty will be exclusive breast feeders (BF), twenty will be exclusive formula feeders (FF) and forty will be mixed-feeders (MF). Infants in all three feeding groups will consume B. infantis for twenty-one consecutive days. Participants will then enter the observational phase until their infant turns 1 year old.
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Exclusively breastfed
Exclusive breastfeeding will be defined at screening as infants who have not consumed any infant formula after 7 days postnatal and have been exclusively breastfed without formula between day 7 of life through the end on the Lead-in period. ). Infants will consume B. infantis for twenty-one consecutive days.
Group Type
ACTIVE_COMPARATOR
Bifidobacterium
Intervention Type
DIETARY_SUPPLEMENT
Each B. infantis (strain: BIEVC001) dose will be provided in one 625 mg sachet delivering 156 mg of live bacteria at a dose of 9x10\^9 CFU plus 469 mg of pharmaceutical-grade lactose as the excipient and dispensed to participants by the study personnel.
Exclusively formula fed
Exclusive formula feeding is defined at screening as infants who consume only infant formula between day 7 of life through the end on the Lead-in period. Infants will consume B. infantis for twenty-one consecutive days.
Group Type
ACTIVE_COMPARATOR
Bifidobacterium
Intervention Type
DIETARY_SUPPLEMENT
Each B. infantis (strain: BIEVC001) dose will be provided in one 625 mg sachet delivering 156 mg of live bacteria at a dose of 9x10\^9 CFU plus 469 mg of pharmaceutical-grade lactose as the excipient and dispensed to participants by the study personnel.
Mixed fed
Mixed feeding is defined at screening as infants who consume a combination of infant formula and breast milk between day 7 of life through the end on the Lead-in period. Infants will consume B. infantis for twenty-one consecutive days.
Group Type
ACTIVE_COMPARATOR
Bifidobacterium
Intervention Type
DIETARY_SUPPLEMENT
Each B. infantis (strain: BIEVC001) dose will be provided in one 625 mg sachet delivering 156 mg of live bacteria at a dose of 9x10\^9 CFU plus 469 mg of pharmaceutical-grade lactose as the excipient and dispensed to participants by the study personnel.
Interventions
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Bifidobacterium
Each B. infantis (strain: BIEVC001) dose will be provided in one 625 mg sachet delivering 156 mg of live bacteria at a dose of 9x10\^9 CFU plus 469 mg of pharmaceutical-grade lactose as the excipient and dispensed to participants by the study personnel.
Intervention Type
DIETARY_SUPPLEMENT
Other Intervention Names
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B. infantis
Eligibility Criteria
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Inclusion Criteria
* Women with infants age 8 to 12 weeks
* Term infants born \>37 weeks gestation
* Mother-infant pairs who live within a 20-mile radius from UC Davis campus in Davis, CA or within a 20-mile UCDMC
* Women and infants who live in one location
* Infants born vaginally
* Infants who are either exclusively formula-fed, exclusively breastfed or mixed-fed
* Women who are mixed and formula feeding their infants who are willing to switch infant formulas and use the study's infant formula (Earth's Best Organic Infant Formula With Iron, Earth's Best) throughout the first two months of the study
* Women who are breastfeeding but introduce infant formula to their infants during the first two months of the study who are willing to use the study's infant formula (Earth's Best Organic Infant Formula With Iron, Earth's Best) for the first two months of the study
* Term infants born \>37 weeks gestation
* Mother-infant pairs who live within a 20-mile radius from UC Davis campus in Davis, CA or within a 20-mile UCDMC
* Women and infants who live in one location
* Infants born vaginally
* Infants who are either exclusively formula-fed, exclusively breastfed or mixed-fed
* Women who are mixed and formula feeding their infants who are willing to switch infant formulas and use the study's infant formula (Earth's Best Organic Infant Formula With Iron, Earth's Best) throughout the first two months of the study
* Women who are breastfeeding but introduce infant formula to their infants during the first two months of the study who are willing to use the study's infant formula (Earth's Best Organic Infant Formula With Iron, Earth's Best) for the first two months of the study
Exclusion Criteria
* Women who have lived in the United States or other developed nation for less than 10 consecutive years
* Multiple infants born to one mother
* Plan to feed infants solid foods before infants turn 5 months of age
* Family history of cow milk or soy allergy and/or infants allergic to cow milk protein or soy
* Infants born by C-section
* Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
* Infants who have taken antibiotics 4 weeks before enrollment and more than one course of antibiotics since birth
* Infants who have taken probiotics since birth
* Plan to administer probiotics to infants or use of probiotics other than the study supplement by infants for the first two months of the study
* Mothers who have a chronic metabolic disease or obesity
* Mothers who currently smoke or plan to resume smoking during the study period
* Infants who consume solid foods or other liquids other than breastmilk, infant formula or water
* Multiple infants born to one mother
* Plan to feed infants solid foods before infants turn 5 months of age
* Family history of cow milk or soy allergy and/or infants allergic to cow milk protein or soy
* Infants born by C-section
* Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
* Infants who have taken antibiotics 4 weeks before enrollment and more than one course of antibiotics since birth
* Infants who have taken probiotics since birth
* Plan to administer probiotics to infants or use of probiotics other than the study supplement by infants for the first two months of the study
* Mothers who have a chronic metabolic disease or obesity
* Mothers who currently smoke or plan to resume smoking during the study period
* Infants who consume solid foods or other liquids other than breastmilk, infant formula or water
Minimum Eligible Age
21 Years
Maximum Eligible Age
45 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Evolve BioSystems, Inc.
INDUSTRY
Sponsor Role
collaborator
University of California, Davis
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jennifer Smilowitz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Mark Underwood, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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University of California, Davis Medical Center
Sacramento, California, United States
Site Status
Countries
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United States
References
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Sela DA, Garrido D, Lerno L, Wu S, Tan K, Eom HJ, Joachimiak A, Lebrilla CB, Mills DA. Bifidobacterium longum subsp. infantis ATCC 15697 alpha-fucosidases are active on fucosylated human milk oligosaccharides. Appl Environ Microbiol. 2012 Feb;78(3):795-803. doi: 10.1128/AEM.06762-11. Epub 2011 Dec 2.
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Sela DA, Li Y, Lerno L, Wu S, Marcobal AM, German JB, Chen X, Lebrilla CB, Mills DA. An infant-associated bacterial commensal utilizes breast milk sialyloligosaccharides. J Biol Chem. 2011 Apr 8;286(14):11909-18. doi: 10.1074/jbc.M110.193359. Epub 2011 Feb 2.
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Garrido D, Nwosu C, Ruiz-Moyano S, Aldredge D, German JB, Lebrilla CB, Mills DA. Endo-beta-N-acetylglucosaminidases from infant gut-associated bifidobacteria release complex N-glycans from human milk glycoproteins. Mol Cell Proteomics. 2012 Sep;11(9):775-85. doi: 10.1074/mcp.M112.018119. Epub 2012 Jun 27.
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Garrido D, Ruiz-Moyano S, Jimenez-Espinoza R, Eom HJ, Block DE, Mills DA. Utilization of galactooligosaccharides by Bifidobacterium longum subsp. infantis isolates. Food Microbiol. 2013 Apr;33(2):262-70. doi: 10.1016/j.fm.2012.10.003. Epub 2012 Oct 22.
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Marcobal A, Barboza M, Froehlich JW, Block DE, German JB, Lebrilla CB, Mills DA. Consumption of human milk oligosaccharides by gut-related microbes. J Agric Food Chem. 2010 May 12;58(9):5334-40. doi: 10.1021/jf9044205.
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Other Identifiers
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738191
Identifier Type: -
Identifier Source: org_study_id