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Did not receive funding to start the trial.
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| Name | Class |
|---|---|
| Evolve BioSystems, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exclusively breastfed | Active Comparator | 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. |
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| Exclusively formula fed | Active Comparator | 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. |
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| Mixed fed | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifidobacterium | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Infant fecal B. infantis | The change in infant fecal B. infantis before, during and after supplementation. | Change from baseline to day 280 |
| Infant fecal Bifidobacterium | The change in infant fecal Bifidobacterium before, during, and after supplementation. | Change from baseline to day 280 |
| Infant fecal total bacteria | The change in infant fecal total bacteria before, during and after supplementation. | Change from baseline to day 280 |
| Infant fecal microbiome | The change in infant fecal microbiome before, during and after supplementation. | Change from baseline to day 280 |
| Infant gastrointestinal symptoms | 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. | Change from baseline to day 50 |
| Infant health status | 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. | Change from baseline to day 280 |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal secretor status | Determine the relationship between human milk oligosaccharides in breast milk and infant fecal microbiome. | Change from baseline to day 280 |
| Infant fecal sialic acid concentrations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Smilowitz, PhD | University of California, Davis | Principal Investigator |
| Mark Underwood, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18266879 | Background | Bager P, Wohlfahrt J, Westergaard T. Caesarean delivery and risk of atopy and allergic disease: meta-analyses. Clin Exp Allergy. 2008 Apr;38(4):634-42. doi: 10.1111/j.1365-2222.2008.02939.x. Epub 2008 Feb 11. | |
| 18352976 | Background | Thavagnanam S, Fleming J, Bromley A, Shields MD, Cardwell CR. A meta-analysis of the association between Caesarean section and childhood asthma. Clin Exp Allergy. 2008 Apr;38(4):629-33. doi: 10.1111/j.1365-2222.2007.02780.x. |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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The change in infant fecal sialic acid and fucose concentrations before, during and after supplementation in infant stool samples.
| Change from baseline to day 280 |
| Infant fecal microbiome and lifestyle | 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. | Change from baseline to day 280 |
| Infant weight | Determine the relationship between infant weight and change in fecal microbiome. | Change from baseline to day 280 |
| Infant fecal short chain fatty acids | Determine the relationship between fecal short chain fatty acids and fecal microbiome. | Change from baseline to day 280 |
| Infant gastrointestinal function | Determine the relationship between GI function (fecal inflammatory, GI barrier mediators, LPS) and fecal microbiome. | Change from baseline to day 280 |
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