A Novel Fecal Sample Collection Method for Metagenomic Analyses

NCT ID: NCT05172414

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2021-08-01

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

No intervention

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Onegevity Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher R. D'Adamo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

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

Baltimore, Maryland, United States

Countries

United States

Related Links

https://www.biorxiv.org/content/10.1101/2021.12.03.471072v1

Pre-print of this study (not peer-reviewed)

Other Identifiers

002

Identifier Type: -

Identifier Source: org_study_id