Aimmune Therapeutics Manufacturing, LLC Longitudinal Collaboration Study: Evaluating the Impact of Lifestyle Factors on the Microbiome

What this Trial Is About

This research aims to study how daily intake of fiber from chia seeds affects the gut microbiome, stool spore colony-forming units, and related biomarkers in healthy adults aged 18 to 50. It focuses on households and individuals around specific US locations, evaluating lifestyle factors like diet and stress and their relationship to gut immune response measured by fecal IgA. The study will also explore how fiber exposure may change gut microbes and immune factors by transplanting samples into germ-free mice for further understanding. Participants will be randomized into two groups in a crossover design over a 16-week period. Half will consume 2.5 tablespoons of chia seeds daily for the first 8 weeks and then return to their usual diet for the next 8 weeks, while the other half will do the opposite. Participants will collect stool samples multiple times weekly using provided tools or at collection sites, alongside blood samples and detailed diet and stress surveys throughout the study. During participation, individuals will complete health questionnaires, daily stress and diet tracking including photos of meals, and provide stool and blood samples. Stool samples will undergo advanced analysis such as metabolomics, sequencing, and IgA testing. Researchers will monitor the gut microbiome's response to fiber and analyze microbes capable of degrading or stimulating IgA. The study includes sample biobanking for future research and collects data on participant experiences and side effects during the intervention.

Aimmune Longitudinal Collaboration Study