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| Name | Class |
|---|---|
| UC Davis Foods for Health Institute | UNKNOWN |
| Mengniu Dairy | UNKNOWN |
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This study is examining the relationship between infant nutrition, gut health, and development. The fecal microbiota changes and develops, in large part due to the food that infants eat. These changes are important for many aspects of development. This study is designed to examine how the fecal microbiota changes when exclusively breastfed infants are first introduced to solid food, and how changes of the fecal microbiota are related to other aspects of development.
The purpose of this study is to determine: 1) how the gut bacteria of exclusively breastfed infants changes in response to ingesting solid foods; 2) how infant cognition develops in response to ingesting solid foods; and 3) the relationship between infant gut bacteria and infant cognition during the first year of life.
This study is designed to determine how specific complex carbohydrates in commonly used first foods encourage the growth of different bacteria in the infant gut. The two foods used in this study are commercially-available sweet potato (Plum Organics) and pear (Earth's Best). These two foods have been chosen because they differ substantially from each other in their carbohydrate composition. For example, sweet potato is mostly made up of starch which is digestible and pear is made up of other types of sugars found in fruits and vegetables that are not digestible and may have "prebiotic" effects (food for good bacteria in the gut). Thus, the use of these two foods could provide a good contrast for comparing how gut bacteria respond to different carbohydrate compositions during complementary feeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sweet Potatos | Experimental | Infants will consume commercially available baby food sweet potato (SP) (Plum Organics, Just Sweet Potato) for 7 days followed by a 4 day washout period of exclusive breast milk. Participants will be instructed to offer 1-2 tablespoons of sweet potato to their infant at least three times per day for seven days in a row. |
|
| Pears | Experimental | Infants will consume commercially available baby food pear (P) (Earth's Best, First Pears) for 7 days followed by a 4 day washout period of exclusive breast milk. Participants will be instructed to offer 1-2 tablespoons of pears to their infant at least three times per day for seven days in a row. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sweet Potatos | Other | Plum Organics, Just Sweet Potato |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Infant fecal microbiota composition | The difference in the relative abundance of the infant fecal microbiome at the order level (top 22 taxonomic orders with abundance expressed as both on log10 scale and a percent of total bacteria) between baseline and post-complementary food intake for each intervention arm (sweet potato vs. pear). | Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180 |
| Infant fecal microbial diversity | The difference in the infant fecal microbial diversity and microbial function between baseline and post-complementary food intake for each arm (sweet potato vs. pear) | Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180 |
| Incidence of Adverse Events and Treatments | Incidence of gastrointestinal symptoms (discomfort passing bowel movements, vomiting, constipation, colic or irritability), illnesses, health care visits for sickness, high fevers, antibiotic and medication use. | Baseline-days 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary composition | The relationship between the relative abundance of the infant fecal microbiome and function, and food glycan composition. | Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180 |
| Infant cognition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Smilowitz, PhD | University of California, Davis | Principal Investigator |
| Lisa Oakes, PhD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Davis | California | 95616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24299467 | Background | Hoskin-Parr L, Teyhan A, Blocker A, Henderson AJ. Antibiotic exposure in the first two years of life and development of asthma and other allergic diseases by 7.5 yr: a dose-dependent relationship. Pediatr Allergy Immunol. 2013 Dec;24(8):762-71. doi: 10.1111/pai.12153. Epub 2013 Dec 2. | |
| 20566857 | Background |
| Label | URL |
|---|---|
| Learn more or sign up for the study here! | View source |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This study is designed as a combined randomized, crossover interventional and observational trial. At the start of the study, infants will enter a 7-day lead-in period to establish gut microbiome and GI tolerability baselines. After the 7-day lead-in period, infants will be randomized into one of two feeding arms comprised of two commercially available baby foods: sweet potato (SP) (Plum Organics, Just Sweet Potato) and pears (P) (Earth's Best, First Pears). The first food, either sweet potato or pears, will be consumed for 7 days followed by a 4-day washout period of exclusive breast milk before initiating the alternate 7-day feeding arm of pears or sweet potato, respectively. The second feeding arm will be followed by an additional 4-day washout period of exclusive breast milk before the introduction of any other solid foods. Once the first month of the study is complete, infants will enter an observational phase for the remainder of the study.
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| Pears |
| Other |
Earth's Best, First Pears |
|
The relationship between the relative abundance of the infant fecal microbiome, microbial diversity and function, and infant cognition measured at 6, 8 and 12 months of age
| Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180 |
| Infant sleep | The relationship between the relative abundance of the infant fecal microbiome, microbial diversity and function, and infant sleep, activity and vocalizations measured throughout the study period. | Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180 |
| Maternal secretor status and infant fecal microbiota | The relationship between maternal secretor status (via measurement of human milk oligosaccharides in breast milk) and the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods. | Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180 |
| Infant secretor status and fecal microbiota | The relationship between infant secretor status (via measurement of oligosaccharides in saliva) the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods. | Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180 |
| Maternal and infant fecal microbiota | The relationship between maternal and infant fecal microbiome. | Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180 |
| Infant fecal human milk oligosaccharide concentrations | The change in infant fecal human milk oligosaccharide concentrations before, during and after introduction of complementary foods. | Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180 |
| Infant weight | Determine the relationship between infant weight and the relative abundance of the infant fecal microbiome, microbial diversity and function before, during and after introduction of complementary foods | Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180 |
| Human milk metabolomics | Determine the relationship between human milk metabolomics (metabolites, fatty acids, proteins) and the infant fecal microbiome. | Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180 |
| Fecal metabolomics | Determine the relationship between fecal metabolites (metabolites, fatty acids, proteins) and fecal microbiome. | Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180 |
| Infant gastrointestinal function | Change in GI function as a means to monitor tolerability before, during and after introduction of complementary foods (through the measurement of fecal inflammatory mediators, GI barrier function markers and fecal LPS). | Change from baseline, days 14, 19, 25, 29, 60, 90, 120, 150, 180 |
| Glycosidic linkages | Evaluate the glycosidic linkages in interventional foods and the infant fecal microbiome. | Change from baseline to day 29 |
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| D005247 | Feeding Behavior |
| D001519 | Behavior |