Exploration of the lung microbiome of post-covid syndrome patients, using ,,next-generation sequencing" (nanopore sequencing)
Organizational Data
- DRKS-ID:
- DRKS00027809
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2022-01-19
- Last update in DRKS:
- 2024-01-29
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The project is started as part of a doctorate. The PhD takes place at the MVZ in Singen in cooperation with the University of Konstanz as well as the Hochschule Furtwangen University. The topic of the PhD is the introduction of one of the newest techniques for sequencing (Nanopore Sequencing) in the microbiological field and in the research of the lung microbiome in Post-Covid Syndrome patients. This leads to the research question and the goals of the PhD. The lung microbiome will be investigated from sputum in post-covid syndrome patients. This means that the change of the lung microbiome after a covid disease with existing symptoms, compared to the normal lung microbiome of a control group, will be presented using the latest sequencing technology. Furthermore, the recovery of the lung microbiome during rehabilitation in post-covid syndrome patients will be demonstrated. All this in order to better understand this novel viral infection and its consequences.
Brief summary in scientific language
The project is started as part of a doctorate. The PhD takes place at the MVZ in Singen in cooperation with the University of Konstanz as well as the Hochschule Furtwangen University. The topic of the PhD is the introduction of "Next-Generation-Sequencing" (NGS), especially Nanopore Sequencing, in the microbiological field and in the research of the lung microbiome in patients suffering from Post-Covid Syndrome. This leads to the research question of the PhD. The lung microbiome will be investigated from sputum in post-covid syndrome patients. This means that the change in the lung microbiome after a covid disease with existing symptoms, compared to the normal lung microbiome, will be presented using NGS. This is all to better understand this novel viral infection and its consequences in the future. The project goals are as follows: Primary The lung microbiome of participants will be investigated using sputum samples. Accordingly, NO experiments will be performed on participants/patients (post-covid syndrome). Of interest is the change in the lung microbiome associated with post-covid syndrome compared to healthy participants (cohort analysis/prospective study). These changes will be shown by NGS. Secondary Furthermore, samples will be taken from post-covid syndrome patients multiple times (e.g. at the beginning of rehabilitation and at the end of rehabilitation) to show the recovery of the lung microbiome (longitudinal analysis/ prospective study). These objectives lead to the following hypotheses: Primary hypothesis: Patients suffering from post-covid syndrome and undergoing rehabilitation will have an altered lung microbiome as a result of a covid infection compared to the control group measured by alpha or beta diversity. Secondary hypothesis: In patients suffering from post-covid syndrome and undergoing rehabilitation, the altered lung microbiome will normalize toward the control group at the end of the rehabilitation period measured by alpha or beta diversity. These two hypotheses are the main hypotheses of the PhD and will be clarified by this prospective study.
Health condition or problem studied
- ICD10:
- U09.9 - Post COVID-19 condition, unspecified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- post-covid syndrome group To visualize and compare the lung microbiome with that of the control group, the DNA is first isolated from the sputum sample, prepared for sequencing, and then next-generation sequencing (nanopore sequencing) is used for sequencing.
- Arm 2:
- control group To visualize and compare the lung microbiome with that of the post-covid syndrome group, the DNA is first isolated from the sputum sample, prepared for sequencing, and then next-generation sequencing (nanopore sequencing) is used for sequencing.
Endpoints
- Primary outcome:
- Primary goal The lung microbiome of participants will be investigated using sputum samples. Accordingly, NO experiments will be performed on participants/patients (post-covid syndrome). Of interest is the change in the lung microbiome associated with post-covid syndrome compared to healthy participants (cohort analysis/prospective study). These changes will be shown by NGS. Primary outcome measure Difference of the microbiome of healthy subjects to the microbiome of patients suffering from post-covid syndrome, measured by alpha diversity.
- Secondary outcome:
- Secondary goal Furthermore, samples will be taken from post-covid syndrome patients multiple times (e.g. at the beginning of rehabilitation and at the end of rehabilitation) to show the recovery of the lung microbiome (longitudinal analysis/ prospective study). Secondary outcome measure To show is the normalization of the lung microbiome of post-covid syndrome patients over the period of rehabilitation in the direction of the control group, measured by alpha diversity.
Study Design
- Purpose:
- Basic research/physiological study
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center MEDICLIN Albert Schweitzer Klinik Königsfeld
- Doctor's practice Singen und Umgebung
Recruitment period and number of participants
- Planned study start date:
- 2024-10-01
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 202
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Inclusion Criteria Post-Covid Syndrome Patients: - Age of majority - Diagnosed Post-Covid Syndrome (Which includes a previously contracted Covid-19 infection confirmed by PCR test). - a confirmed previously acquired Covid-19 infection (PCR test). - Furthermore, vaccinated and non-vaccinated patients will be included. Inclusion Criteria control group: - Age of majority - Vaccinated and non-vaccinated patients will be included.
Exclusion Criteria
Exclusion Criterion Post-Covid Syndrome Patients: - Positive PCR test at specimen collection (A PCR test will be performed from sputum at specimen collection to ensure that there is no active undetected infection. This is regulated by the informed consent). Exclusion Criteria Control Group: - Positive PCR test at specimen collection (A PCR test will be performed from the sputum at specimen collection to ensure that there is no active undetected infection. This is regulated by the consent form). - Previous knowingly confirmed passed Covid-19 infection (PCR test).
Addresses
Primary Sponsor
- Address:
- MVZ Laborärzte SingenVirchowstr. 10c78224 SingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Hochschule Furtwangen University, Fakultät Medical and Life SciencesProf. Dr. med. Folker WenzelJakob-Kienzle-Straße 1778054 78054 VS-SchwenningenGermany
- Telephone:
- 07720 307 4358
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- MVZ Laborärzte SingenM.Sc. Philipp SchneeVirchowstr. 10c78224 SingenGermany
- Telephone:
- 0 7731 9956 132
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Hochschule Furtwangen University, Fakultät Medical and Life SciencesProf. Dr. med. Folker WenzelJakob-Kienzle-Straße 1778054 78054 VS-SchwenningenGermany
- Telephone:
- 07720 307 4358
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- MVZ Laborärzte SingenVirchowstr. 10c78224 SingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission bei der Landesärztekammer Baden-WürttembergLiebknechtstr. 3370565 StuttgartGermany
- Telephone:
- +49-711-7698919
- Fax:
- +40-711-76989856
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-07-30
- Ethics committee number:
- F-2021-111
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-12-23
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry