A Novel Fecal Sample Collection Method for Metagenomic Analyses

NCT05172414 | Completed

• 1 other identifier: 002
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

gut microbiome; metagenomic sequencing; stool collection

Outcome Measures

Primary Outcomes (1)

• Dissolvable Wipe Comparison to Commercially Available Kits

  The primary outcome was is to assess the extent to which our novel approach to fecal sample collection (dissolvable wipe) and stabilization could maintain microbiota composition relative to immediate freezing (-20°C), preservation with a commercially available kit, and storage at room temperature (RT).

  1 timepoint, 6 subjects, comparing the 4 collections in kits from a stool sample at 3 sites on a bowel movement. Each subject collected their sample on one day, and all samples were collected over one week.

Interventions

No intervention OTHER

The single group had no intervention. All followed the same procedures of different collection methods.

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In order to account for potential drop-out, 6 participants were enrolled to achieve a properly-powered sample size. This target sample size was informed by the literature review and power analysis. Both males and females could participate, ages 18+, with no exclusions to race or ethnicity.

You may qualify if:

• \. Adults, age ≥ 18 years 2. With normal to slightly diarrhea feces (Bristol Stool Scale - type 4 and type 5) 3. Agree to collect and donate the feces 4. Able to understand and write English 5. Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects

You may not qualify if:

• \. People with constipation, slightly dry or diarrhea feces (Bristol Stool Scale - type 1-3 and type 6-8) 2. Pregnant or breastfeeding females 3. History of alcohol, drug, or medication abuse 4. Known allergies to any substance in the study product 5. Current diagnosis of inflammatory bowel disease (Crohn's or Ulcerative Colitis) 6. Taking medication that may interfere with the defecation
• Vulnerable Participants: No children, pregnant women, nursing home residents or other institutionalized persons, prisoners, or any other vulnerable participants were eligible to participate in this study.

Sponsors & Collaborators

• Onegevity Health: lead

Study Sites (1)

Center for Integrative Medicine at the University of Maryland School of Medicine

Baltimore, Maryland, 20742, United States

Location

Related Links

• Pre-print of this study (not peer-reviewed)

Biospecimen

Retention: SAMPLES WITH DNA

Metagenomic (DNA) analysis of (stool) gut microbiome samples

Study Officials

• Christopher R. D'Adamo, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 29, 2021
• Study Start: January 2, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2021
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

US (1)