Aimmune Longitudinal Collaboration Study
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 sampl
| Condition(s) | Stool Spore Colony Forming Units, Microbiome Composition, Dietary Fiber, Stress |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: 1. 18 years of age or greater 2. Able to sign informed consent in English 3. Households (2 or more adults) or individuals who are willing to provide a minimum of 3 separate stool samples per week and utilize a manual stool sampling tool. Alternatively, participants who can come to a collection site and leave stool samples a minimum of 3 days per week throughout the duration of the study. 4. Are generally healthy 5. Agreeable to adding chia seeds to diet 6. Have access to a smartphone Exclusion Criteria: 1. Less than 18 years of age 2. Greater than 50 years of age 3. Unable to provide a minimum of 3 stool samples per week 4. Active donors for a commercial product 5. Anyone who previously made a lot of a finished product 6. Diagnosed with a digestive, intestinal, or other |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Aimmune Therapeutics, Inc. |
| Locations | Ambler, Pennsylvania, United States; Ambler, Pennsylvania, United States |
| Start date | 2025-10 |
| NCT ID | NCT07218640 |
| Official listing | https://clinicaltrials.gov/study/NCT07218640 |