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Trial record 1 of 1 for:    18181719 [PUBMED-IDS]
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Milk Oriented Microbiota (MOM)

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ClinicalTrials.gov Identifier: NCT03222804
Recruitment Status : Withdrawn (Withdrawn due to loss of funding)
First Posted : July 19, 2017
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
Evolve BioSystems, Inc.
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Microbial Colonization Dietary Supplement: Bifidobacterium Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Establishing a Milk Oriented Microbiota in Healthy Term Infants
Estimated Study Start Date : May 2017
Actual Primary Completion Date : March 6, 2018
Actual Study Completion Date : March 6, 2018

Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: 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.
Other Name: B. infantis

Active Comparator: 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.
Dietary Supplement: 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.
Other Name: B. infantis

Active Comparator: 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.
Dietary Supplement: 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.
Other Name: B. infantis




Primary Outcome Measures :
  1. Infant fecal B. infantis [ Time Frame: Change from baseline to day 280 ]
    The change in infant fecal B. infantis before, during and after supplementation.

  2. Infant fecal Bifidobacterium [ Time Frame: Change from baseline to day 280 ]
    The change in infant fecal Bifidobacterium before, during, and after supplementation.

  3. Infant fecal total bacteria [ Time Frame: Change from baseline to day 280 ]
    The change in infant fecal total bacteria before, during and after supplementation.

  4. Infant fecal microbiome [ Time Frame: Change from baseline to day 280 ]
    The change in infant fecal microbiome before, during and after supplementation.

  5. Infant gastrointestinal symptoms [ Time Frame: Change from baseline to day 50 ]
    Gastrointestinal symptoms and related symptoms (discomfort passing bowel movements, vomiting, constipation, colic or irritability) before, during and after supplementation will be determined and reported daily by parental self-report questionnaire.

  6. Infant health status [ Time Frame: Change from baseline to day 280 ]
    General health status of the infant such as occurrence of any illness, health care visits for sickness, fever, antibiotic and medication use and parental assessments of infant's overall health.


Secondary Outcome Measures :
  1. Maternal secretor status [ Time Frame: Change from baseline to day 280 ]
    Determine the relationship between human milk oligosaccharides in breast milk and infant fecal microbiome.

  2. Infant fecal sialic acid concentrations [ Time Frame: Change from baseline to day 280 ]
    The change in infant fecal sialic acid and fucose concentrations before, during and after supplementation in infant stool samples.

  3. Infant fecal microbiome and lifestyle [ Time Frame: Change from baseline to day 280 ]
    Determine the relationship between the following factors determined by self-report questionnaires: parity, maternal and infant antibiotic intake and maternal use of antimicrobials, infant intake of formula; and the change infant fecal microbiome.

  4. Infant weight [ Time Frame: Change from baseline to day 280 ]
    Determine the relationship between infant weight and change in fecal microbiome.

  5. Infant fecal short chain fatty acids [ Time Frame: Change from baseline to day 280 ]
    Determine the relationship between fecal short chain fatty acids and fecal microbiome.

  6. Infant gastrointestinal function [ Time Frame: Change from baseline to day 280 ]
    Determine the relationship between GI function (fecal inflammatory, GI barrier mediators, LPS) and fecal microbiome.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03222804


Locations
United States, California
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Evolve BioSystems, Inc.
Investigators
Principal Investigator: Jennifer Smilowitz, PhD University of California, Davis
Principal Investigator: Mark Underwood, MD University of California, Davis

Publications:
Zivkovic AM, Lewis ZT, German JB, Mills DA. Establishment of a milk-oriented microbiota (MOM) in early life: How babies meet their MOMs. . Functional Food Reviews. 2013;5:3-12.
Barile D, Guinard J, Meyrand M, German JB. Examining bioactive components of milk: complex oligosaccharides. AgroFood. 2011;22(4):12-6.
Barile D, Meyrand M, Lebrilla CB, German JB. Examining bioactive components of milk Sources of complex oligosaccharides (Part 2). Agro Food Industry Hi-Tech. 2011;22(4):37-9.

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03222804     History of Changes
Other Study ID Numbers: 738191
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

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

Keywords provided by University of California, Davis:
Infants
Probiotic
B. Infantis

Additional relevant MeSH terms:
Communicable Diseases
Infection