A Novel Fecal Sample Collection Method for Metagenomic Analyses

Healthy Clinical Trial

Official title:

A Novel Fecal Sample Collection Method for Metagenomic Analyses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05172414
• Other study ID #: 002
• Status: Completed
• Start date: January 2, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: October 2023
• Source: Onegevity Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• 1. 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

Exclusion Criteria:

• 1. 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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Center for Integrative Medicine at the University of Maryland School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Onegevity Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   Pre-print of this study (not peer-reviewed)