Aimmune Longitudinal Collaboration Study

NCT07218640 | Recruiting

• 1 other identifier: MSRD001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

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

Keywords

Spore Colony-Forming Units; Dietary fiber; Stress; Microbiome

Outcome Measures

Primary Outcomes (1)

• Stool SCFU (Spore Colony-Forming Units)

  Evaluate the impact of increased dietary fiber (an estimated additional 10 g per day) on stool SCFU (Spore Colony-Forming Units).

  8 weeks

Secondary Outcomes (2)

• Stool SCFU (Spore Colony-Forming Units)

  16 weeks

• Biomarkers and Microbiome Composition

  16 weeks

Study Arms (2)

Baseline Diet

NO INTERVENTION

Participants will consume their baseline diet for 8 weeks

Chia seeds daily

EXPERIMENTAL

Participants will consume 2.5 tbsp chia seeds daily for 8 weeks

Other: Chia seeds

Interventions

Chia seeds OTHER

Participant will add 2.5 tbsp daily chia seeds to their diet for 8 weeks

Chia seeds daily

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age or greater
• Able to sign informed consent in English
• 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.
• Are generally healthy
• Agreeable to adding chia seeds to diet
• Have access to a smartphone

You may not qualify if:

• Less than 18 years of age
• Greater than 50 years of age
• Unable to provide a minimum of 3 stool samples per week
• Active donors for a commercial product
• Anyone who previously made a lot of a finished product
• Diagnosed with a digestive, intestinal, or other condition that contraindicates consuming a daily serving size of chia seeds (\~2.5 tbsp).

Sponsors & Collaborators

• Aimmune Therapeutics, Inc.: lead

Study Sites (2)

Aimmune Therapeutics Manufacturing

Ambler, Pennsylvania, 19002, United States

RECRUITING

GoodNature Tempe

Ambler, Pennsylvania, 19002, United States

RECRUITING

Study Officials

• Jason Goldsmith, MD, PhD

  Nestle Health Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Nelson, NP

CONTACT

267-405-1914; allison.nelson@us.nestle.com

Nicole Delehanty, DNP

CONTACT

267-405-1914; Nicole.Delehanty@us.nestle.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 20, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months and ending 2 years after the publication of results
• Access Criteria: Proposals must be submitted to the Sponsor to receive the IPD and data analysis through a commercially available portal. The URL is not currently available but will be made available after the study is published.

Locations

US (2)