Comparison of Different Methods for the Analysis of Gut Microbiome Composition

NCT04082221 | Completed

• 1 other identifier: ChariteU-ECRC-COLLECT
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The human gastrointestinal tract shelters a complex and dynamic population of microorganisms, the gut microbiota, which plays an important role in immune and metabolic homeostasis. In recent years several major diseases were linked with alterations in the gut microbiome composition. There are known factors which can influence gut microbiata composition. For example diet is known to play a fundamental role in determining the composition of the intestinal microbiota over time. However, there are very few studies evaluating how collection and DNA isolation methods affect microbiome composition.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Collection of stool samples

  Collection of 2 stool samples in one week using different conditions DNA extraction from all samples will be performed using QIAamp Power Fecal (Qiagen, N. V) and ZymoBIOMICS (Zymo Research, CA.) to assess how different commercially available stool sampling kits and fecal DNA extraction kits influence the apparent composition of the gut microbiome

  one week

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects

You may qualify if:

• Age between 18-60
• Body mass index (BMI) 18,5- 29,9 kg/m2
• Willingness to participate in the study examination and fecal sample collection process

You may not qualify if:

• Subjects currently on medication (with the exception of contraceptives)
• Subjects with acute or chronic disease
• Pregnant or lactating women
• Subjects with a history of drug or alcohol abuse
• Subjects on a vegan diet
• Subjects who are legal incapacitated or their circumstances do not enable the patient to fully understand the nature, significance and scope of this study.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Experimental and Clinical Research Center, Clinical Research Unit

Berlin, 13125, Germany

Location

Related Publications (2)

• Hart ML, Meyer A, Johnson PJ, Ericsson AC. Comparative Evaluation of DNA Extraction Methods from Feces of Multiple Host Species for Downstream Next-Generation Sequencing. PLoS One. 2015 Nov 24;10(11):e0143334. doi: 10.1371/journal.pone.0143334. eCollection 2015.

  PMID: 26599606 BACKGROUND

• Wesolowska-Andersen A, Bahl MI, Carvalho V, Kristiansen K, Sicheritz-Ponten T, Gupta R, Licht TR. Choice of bacterial DNA extraction method from fecal material influences community structure as evaluated by metagenomic analysis. Microbiome. 2014 Jun 5;2:19. doi: 10.1186/2049-2618-2-19. eCollection 2014.

  PMID: 24949196 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Stool (stool DNA), Blood Serum and Blood Plasma

Study Officials

• Anja Mähler, PhD

  Franz-Volhard-Centr. at the Experimental and Clinicial Research Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: March 11, 2019
• Primary Completion: June 30, 2019
• Study Completion: September 5, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

DE (1)