NCT05172414

A Novel Fecal Sample Collection Method for Metagenomic Analyses

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Onegevity Health · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, one-arm, one-time-point pilot assessing the intra- and inter-group variation of gut microbiome collection methods and storage conditions using metagenomic sequencing for analysis. This study recruited 6 adult volunteers collecting 12 fecal samples from one bowel movement. Subjects were given detailed instructions as to collect and store feces samples into the 4 different collection and preservation methods and return samples for metagenomic analysis.

Detailed description

A total of 6 subjects were enrolled in this pilot study. The inclusion criteria to be enrolled in the study included: age \>18; Bristol Stool Scale type 3 and 4 (normal), agree to collect and donate the feces, and the ability to understand and write English. Exclusion criteria included people with constipation, slightly dry, or diarrhea feces (Bristol Stool Scale types 1-2, 5-7), pregnant or breastfeeding females, history of alcohol, drug, or medication abuse, known allergies to any substance in the study product, current diagnosis of inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis), and currently taking any medication that may interfere with defecation. Fecal collection kits were mailed to subjects with instructions for sample collection. A total of 12 samples (3 sites on the bowel movement, 4 collection/preserving methods) were collected by each subject yielding a total of 72 samples to be processed. Four preservation methods were used to process the samples for metagenomic sequencing: freezing (-20°C), room temperature storage, Zymo DNA shield kit (room temperature), and DESS DNA preservation (room temperature). All the samples are shipped at room temperature except the samples meant for freezing which were shipped on dry ice. At the lab, all the samples were put into a fridge (4°C) except the frozen samples which were put in a -20°C freezer. Samples underwent DNA extraction and sequencing per previously published methods with the objective to understand intra- and inter-sample comparisons for collection methods and stability during storage/shipping. Results will include taxonomic abundance metrics, metabolic pathway classification, and diversity analysis.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	No intervention	The single group had no intervention. All followed the same procedures of different collection methods.

Timeline

• Start date: 2020-01-02
• Primary completion: 2020-08-01
• Completion: 2021-08-01
• First posted: 2021-12-29
• Last updated: 2023-11-01

Locations

1 site across 1 country: United States