Bacteria Infection MechanismNCT04552496
Cryptic Bacteria of the Thyroid Tissue as a Possible Cause of the Pathology of This Organ
An observational study of Bacteria Infection Mechanism, run by Centre of Postgraduate Medical Education at 2 sites in Poland.
Trial summary
The presence of cryptic microbes has been widely documented in animal healthy deep tissues. The thyroid gland is an organ specifically exposed to the microbial environment due to its close location to the mouth microbiome. A number of bacterial phenotypes has been detected in the inflamed thyroid gland. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bacteria Infection Mechanism
- How many people
- 120 participants
- Where
- 2 sitesPoland
- Study dates
- 5 Jul 2018to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with thyroid disease who require surgery. Preoperative clinical diagnosis: 1) non-toxic multinodular goiter, 2) toxic multinodular goiter, 3) Graves disease, 4) single adenoma, 5) Hashimoto's disease, 6) thyroid cancer and 7) recurrent thyroid disease.
Who may be able to join
- thyroid disease requiring surgery
Who cannot join
- acute or chronic infection at remote sites
- treated with antibiotics over the last 3 months
Trial locations and contacts
2 sites in 1 country.
Waldemar L. Olszewski, MD, PhD contact
Poland2 sites, 2 recruiting
- Recruiting
Department of General, Oncological and Gastrointestinal Surgery, Centre of Postgraduate Medical Education
Warsaw, 00-416
Sergiusz Durowicz, MD, PhD, +48226217173, sdurowicz@wp.pl
Sergiusz Durowicz, MD, PhD
- Recruiting
Department of Applied Physiology, Mossakowski Medical Research Centre, Polish Academy of Sciences
Warsaw, 02-106
Marzanna Zaleska, PhD, mzaleska34@gmail.com
Marzanna Zaleska, PhD
About this study
Official title: The Thyroidectomy Wound Inflammation Can be Caused by Microbes Present in the Thyroid Parenchyma - Observational Research
The presence of cryptic microbes has been widely documented in animal healthy deep tissues.
The thyroid gland is an organ specifically exposed to the microbial environment due to its close location to the mouth microbiome. A number of bacterial phenotypes has been detected in the inflamed thyroid gland. A question raises as to whether bacteria have not already been present in the thyroid gland before the clinical symptoms of goiter became evident.
Read more
A problem in thyroid surgery, relatively uncommon but difficult for control, is prolonged thyroidectomy wound healing with skin flap, gland bed inflammation and fibrosis. The causative bacteria may belong to the strains persistently present in the thyroid gland parenchyma. Our objective is to answer questions: a) do the goiter tissue structures contain bacteria, b) if so, which bacterial phenotypes can be identified, c) what are the genetic similarities of the thyroid and periodontal bacterial strains.
Studies are carried out in patients with non-toxic multinodular goiter, toxic multinodular goiter, Graves' disease, single adenoma, Hashimoto's disease, thyroid cancer and recurrent thyroid disease. Tissue harvested during surgery is dissected immediately after thyroidectomy into fragments of parenchyma, arteries, veins and lymph nodes and cultured on Columbia blood agar base for up to 3 weeks. In this method bacteria present in the tissue grow in their natural environment, slowly proliferate and then form the on-plate colonies. It enables detection of even single bacteria usually difficult to be identified in planktonic media. Identification of the isolated bacteria is performed. Their DNA patterns are also compared.
- Conditions
- Bacteria Infection Mechanism
What is being measured
The primary outcome is the main question the study is designed to answer.
In vivo transferred to ex vivo bacteria culturing in thyroid tissue fragments. The percentage of positive bacterial growth
Thyroid tissue specimens placed on Columbia agar with sheep blood plate and cultured for up to 30 days. Measurement of the percentage of positive bacterial growth.
Measured: 30 days
In vivo transferred to ex vivo bacteria culturing in thyroid tissue fragments. Time lapse to the first bacterial colonies appearance
Thyroid tissue specimens placed on Columbia agar with sheep blood plate and cultured for up to 30 days. Optical assessment of colonies growth kinetic. Measurement of time lapse in days to the first bacterial colonies appearance.
Measured: 30 days
Identification of bacterial strains isolated from cultured thyroid tissue fragments
Isolates identification by standard procedures using the Analytical Profile Identification (API) System (Biomerieux). Assessment of the percentage of bacterial strains cultured from thyroid fragments.
Measured: 3 days
Antibiotic sensitivity of bacterial strains isolated from cultured thyroid tissue fragments
Assessment of the sensitivity of isolated bacterial strains to antibiotics using the ATB system and the ATB-Plus reader (Biomerieux, Paris, France). The percentage of isolated strains sensitive to tested antibiotics.
Measured: 4 days
Isolated bacteria Polymerase Chain Reaction Melting Profiles (PCR MP)
The comparison of DNA patterns of strains isolated from thyroid and oral cavity. The analysis of similarity of the genetic pattern as percentage using the GeneTools program (Syngene, Cambridge, United Kingdom).
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start5 Jul 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacteria Infection MechanismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergiusz Durowicz, Centre of Postgraduate Medical Education
- Investigators
- Sergiusz Durowicz, MD, PhD, Principal investigator, Centre of Postgraduate Medical Education, Warsaw, PolandMarzanna Zaleska, PhD, Principal investigator, Mossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw, PolandWaldemar L. Olszewski, MD, PhD, Principal investigator, Central Clinical Hospital Ministry Interior Administration, Warsaw, PolandWiesław Tarnowski, Md, PhD, Principal investigator, Centre of Postgraduate Medical Education, Warsaw, PolandEwa Swoboda-Kopeć, MD, PhD, Principal investigator, Medical University of Warsaw, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552496
- Sponsor's protocol ID
- 85/PB/2018
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thyroidectomy Wound Inflammation Can be Caused by Microbes Present in the Thyroid Parenchyma - Observational Research
- ClinicalTrials.gov ID
- NCT04552496
- Acronym / sponsor ID
- 85/PB/2018
- Conditions
- Bacteria Infection Mechanism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The presence of cryptic microbes has been widely documented in animal healthy deep tissues.
The thyroid gland is an organ specifically exposed to the microbial environment due to its close location to the mouth microbiome. A number of bacterial phenotypes has been detected in the inflamed thyroid gland. A question raises as to whether bacteria have not already been present in the thyroid gland before the clinical symptoms of goiter became evident.
A problem in thyroid surgery, relatively uncommon but difficult for control, is prolonged thyroidectomy wound healing with skin flap, gland bed inflammation and fibrosis. The causative bacteria may belong to the strains persistently present in the thyroid gland parenchyma. Our objective is to answer questions: a) do the goiter tissue structures contain bacteria, b) if so, which bacterial phenotypes can be identified, c) what are the genetic similarities of the thyroid and periodontal bacterial strains.
Studies are carried out in patients with non-toxic multinodular goiter, toxic multinodular goiter, Graves' disease, single adenoma, Hashimoto's disease, thyroid cancer and recurrent thyroid disease. Tissue harvested during surgery is dissected immediately after thyroidectomy into fragments of parenchyma, arteries, veins and lymph nodes and cultured on Columbia blood agar base for up to 3 weeks. In this method bacteria present in the tissue grow in their natural environment, slowly proliferate and then form the on-plate colonies. It enables detection of even single bacteria usually difficult to be identified in planktonic media. Identification of the isolated bacteria is performed. Their DNA patterns are also compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with thyroid disease who require surgery. Preoperative clinical diagnosis: 1) non-toxic multinodular goiter, 2) toxic multinodular goiter, 3) Graves disease, 4) single adenoma, 5) Hashimoto's disease, 6) thyroid cancer and 7) recurrent thyroid disease.
Key inclusion criteria (1 listed)
- thyroid disease requiring surgery
Key exclusion criteria (2 listed)
- acute or chronic infection at remote sites
- treated with antibiotics over the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In vivo transferred to ex vivo bacteria culturing in thyroid tissue fragments. The percentage of positive bacterial growth
Time frame: 30 days
Thyroid tissue specimens placed on Columbia agar with sheep blood plate and cultured for up to 30 days. Measurement of the percentage of positive bacterial growth.
In vivo transferred to ex vivo bacteria culturing in thyroid tissue fragments. Time lapse to the first bacterial colonies appearance
Time frame: 30 days
Thyroid tissue specimens placed on Columbia agar with sheep blood plate and cultured for up to 30 days. Optical assessment of colonies growth kinetic. Measurement of time lapse in days to the first bacterial colonies appearance.
Identification of bacterial strains isolated from cultured thyroid tissue fragments
Time frame: 3 days
Isolates identification by standard procedures using the Analytical Profile Identification (API) System (Biomerieux). Assessment of the percentage of bacterial strains cultured from thyroid fragments.
Antibiotic sensitivity of bacterial strains isolated from cultured thyroid tissue fragments
Time frame: 4 days
Assessment of the sensitivity of isolated bacterial strains to antibiotics using the ATB system and the ATB-Plus reader (Biomerieux, Paris, France). The percentage of isolated strains sensitive to tested antibiotics.
Isolated bacteria Polymerase Chain Reaction Melting Profiles (PCR MP)
Time frame: 3 days
The comparison of DNA patterns of strains isolated from thyroid and oral cavity. The analysis of similarity of the genetic pattern as percentage using the GeneTools program (Syngene, Cambridge, United Kingdom).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waldemar L. Olszewski, MD, PhD contact
Sergiusz Durowicz, MD, PhD principal investigator
Centre of Postgraduate Medical Education, Warsaw, Poland
Marzanna Zaleska, PhD principal investigator
Mossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw, Poland
Waldemar L. Olszewski, MD, PhD principal investigator
Central Clinical Hospital Ministry Interior Administration, Warsaw, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteria Infection Mechanism, run by Centre of Postgraduate Medical Education at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergiusz Durowicz, MD, PhD (+48226217173, sdurowicz@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In vivo transferred to ex vivo bacteria culturing in thyroid tissue fragments. The percentage of positive bacterial growth (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.