Aimmune Longitudinal Collaboration Study

Part of paid clinical trials in Ambler, Pennsylvania.

Sponsor
Aimmune Therapeutics, Inc.
Study ID
NCT07218640
Status
Recruiting
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Conditions

  • Dietary Fiber
  • Microbiome Composition
  • Stool Spore Colony Forming Units
  • Stress

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Chia seeds — OTHER
    Participant will add 2.5 tbsp daily chia seeds to their diet for 8 weeks

Study Details

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 are IgA low (undetectable) throughout the study will be evaluated from the presence of microbes that can degrade IgA. If investigators find this is the case, investigators will screen for microbes that can degrade IgA. For individuals that show persistent high fecal IgA or show a substantial improvement in IgA, investigators will transplant fecal samples or spores from fecal samples into germ-free mice to further understand the microbiome and pathophysiology relationship. For the latter, the investigator's hypothesis is that fiber exposure of a specific type will reprogram the microbiome to stimulate IgA broadly to the entire microbiome as occurs with pectin derivative treated mice. The investigator's goal will be to isolate the microbes that respond to fiber to alter levels of IgA in the gut lumen.

Key Dates

Start date
Oct 31, 2025
Status verified
Oct 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • No Intervention: Baseline Diet
    Participants will consume their baseline diet for 8 weeks
  • Experimental: Chia seeds daily
    Participants will consume 2.5 tbsp chia seeds daily for 8 weeks

Primary Outcome Measure

Stool SCFU (Spore Colony-Forming Units) [ Time Frame: 8 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Aimmune Therapeutics ManufacturingAmblerPennsylvania19002
Jason Goldsmith, MD, PhD
[email protected]
267-405-1914
Ketan Patel, MD
[email protected]
267-405-1914
Jason Goldsmith, MD, PhD (PRINCIPAL_INVESTIGATOR)
GoodNature TempeAmblerPennsylvania19002
Jason Goldsmith, MD, PhD
[email protected]
267-405-1914
Elisha Ott
[email protected]
470-306-5240
Jason Goldsmith, Md, PhD (PRINCIPAL_INVESTIGATOR)

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