PRObing The Efficacy of Commercial Stage Storage Buffers and Evaluating Gut Metaproteome Variability Between Individuals

NCT06423508 | Recruiting

• 1 other identifier: EK_01149_3/05/2024
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess the effectiveness of various commercial and non-hazardous buffers for the storage of human gut fecal samples over time. This evaluation will be conducted by comparing the performance of these buffers against directly frozen samples using metaproteomic analysis. The study is motivated by the need for standardized protocols for sample preservation in metaproteomic research, particularly focusing on protein preservation in fecal samples. By investigating proteomic, taxonomic, and functional identifications, the research seeks to provide insights into the reliability of these buffers as storage solutions. Additionally, the study plans to explore inter- and intra-individual variabilities at the proteome level by periodically collecting fecal samples from volunteers, complementing existing knowledge in metaproteomics. Overall, the study addresses a critical gap in the field and has the potential to enhance reproducibility and comparability across metaproteomic studies

Conditions

Gut Microbiome; Buffer; Methodology Study; Fecal Microbiota; Variability

Keywords

storage buffer; fecal samples; human gut microbiome; metaproteomics; intra-individual variability; inter-individual variability

Outcome Measures

Primary Outcomes (1)

• Eggerthella abundance

  Eggerthella abundance will be checked in to the Metaproteomic profile of each fecal samples and inter/intra-individual variability will be assessed

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (5)

• Age

  From enrollment to the end of treatment at 4 weeks

• Sex

  From enrollment to the end of treatment at 4 weeks

• Body Mass Index (BMI)

  From enrollment to the end of treatment at 4 weeks

• Antibiotic use

  From enrollment to the end of treatment at 4 weeks

• Bristrol Stool Form Scale (BSFS)

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

storage buffer standardisation

Identifying the most effective storage buffer for preserving protein integrity during the transportation of fecal samples from collection to processing sites, is essential for establishing consistent sample collection protocols, particularly for large-scale human fecal proteomic studies. Achieving consistency in sample collection is crucial for enabling individuals to have their gut health assessed via metaproteomics, unlocking the potential for personalized medicine and therapeutic interventions based on microbial communities.

inter- and intra-individual variability

the aim is to explore the inter- and intra-individual variability observed in gut microbiome composition and functions from a proteomic perspective. Understanding inter-individual variability differences is crucial for personalized medicine. Recognizing and characterizing intra-individual variability is essential for accurately interpreting research findings, particularly in longitudinal studies or clinical monitoring scenarios. This study aims to elucidate these variabilities using proteomic data from volunteers' fecal samples, shedding light on the variables detected in the gut microbiome and providing insights into its dynamic nature

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers (among the members of our laboratory/Division) will be recruited

You may qualify if:

• agreeing to participate after signing the informed consent form and
• being 18-70 years old.

You may not qualify if:

• take antibiotics during the previous 1 month
• had undergone gastrointestinal surgery

Sponsors & Collaborators

• University of Vienna: lead

Study Sites (1)

UVienna

Vienna, Vienna, 1090, Austria

RECRUITING

Related Publications (1)

• Gomez-Varela D, Xian F, Grundtner S, Sondermann JR, Carta G, Schmidt M. Increasing taxonomic and functional characterization of host-microbiome interactions by DIA-PASEF metaproteomics. Front Microbiol. 2023 Oct 16;14:1258703. doi: 10.3389/fmicb.2023.1258703. eCollection 2023.

  PMID: 37908546 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

human fecal samples

Study Officials

• Giacomo Carta, PhD

  University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Gomez Varela PhD. Senior Scientist, PhD

CONTACT

1427755361; david.gomez.varela@univie.ac.at

Ranjith Kumar Ravi Kumar PhD- postdoc, PhD

CONTACT

1427755318; ranjith.kumar.ravi.kumar@univie.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: December 3, 2024
• Primary Completion: December 30, 2024
• Study Completion: September 30, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)