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Comparison of Different Methods for the Analysis of Gut Microbiome Composition (COLLECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082221
Recruitment Status : Completed
First Posted : September 9, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Lajos Marko, Charite University, Berlin, Germany

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.


Condition or disease Intervention/treatment
Healthy Other: no intervention

Detailed Description:
An observational clinical study with 28 healthy subjects is planned to assess how different commercially available stool sampling kits and fecal DNA extraction kits influence the apparent composition of the gut microbiome. Participants will be instructed to collect stool samples at two time points separated by one week using six different methods (naïve and Zymo DNA/RNA Shield kit on dry ice as well as OMNIgene GUT, RNALater, 95% EtOH, Zymo DNA/RNA Shield at room temperature). DNA extraction from all samples will be performed using QIAamp Power Fecal (Qiagen, N. V) and ZymoBIOMICS (Zymo Research, CA.).

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Influence of Different Sample Collection and DNA Extraction Methods on the Bacterial Composition of the Gut of Healthy Subjects
Actual Study Start Date : March 11, 2019
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : September 5, 2019

Intervention Details:
  • Other: no intervention
    no intervention


Primary Outcome Measures :
  1. Collection of stool samples [ Time Frame: one week ]

    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



Biospecimen Retention:   Samples With DNA
Stool (stool DNA), Blood Serum and Blood Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082221


Locations
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Germany
Experimental and Clinical Research Center, Clinical Research Unit
Berlin, Germany, 13125
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Study Chair: Anja Mähler, PhD Franz-Volhard-Centr. at the Experimental and Clinicial Research Center
Publications:
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Responsible Party: Dr. Lajos Marko, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04082221    
Other Study ID Numbers: ChariteU-ECRC-COLLECT
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No