Condition: Stool Spore Colony Forming Units · Microbiome Composition · Dietary Fiber · Sponsor: Aimmune Therapeutics, Inc.
This study will include healthy households around the Irvine, CA area (based local to employees) and Tempe, AZ and Philadelphia, PA sites that will be instructed to take a daily fiber supplement (2.5 tablespoons of chia seeds \[\~10.3g of fiber\] which is one serving) for two months. Participants will use a stool sampling tool to facilitate ease of stool collection, or they may donate at a study site. Half of participants will add chia seeds to their diet at the beginning of the study and then return to their baseline diet for the second half of the study; half of participants maintain their baseline diet for the first half of the study and add chia seeds to their diet at the second half of the study as a cross-over design. Households (or individual participants, if their household is not participating) will be chosen at random to decide who implements the intervention in the first half versus the second half of the study. Data measurement including metabolomics and sequencing of stool samples, blood sampling for biobanking, stool IgA analysis, stress and diet evaluations will occur initially and throughout the study. Lifestyle questionnaires including but not limited to diet surveys, stress, or depression screening may be collected through electronic forms or telephonically. During enrollment, participants may be asked to complete questionnaires focused on medical, family, dietary, and social histories. At the end of the study, donor microbiota samples from individuals that…
This description comes directly from the study's public registry record.
Allison Nelson, NP · 267-405-1914 · allison.nelson@us.nestle.com
Nicole Delehanty, DNP · 267-405-1914 · Nicole.Delehanty@us.nestle.com
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| Aimmune Therapeutics Manufacturing | Ambler, Pennsylvania, United States | Recruiting |
| GoodNature Tempe | Ambler, Pennsylvania, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07218640