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Cryptic Bacteria of the Thyroid Tissue as a Possible Cause of the Pathology of This Organ

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ClinicalTrials.gov Identifier: NCT04552496
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Sergiusz Durowicz, Centre of Postgraduate Medical Education

Brief 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. 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.


Condition or disease
Bacteria Infection Mechanism

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Thyroidectomy Wound Inflammation Can be Caused by Microbes Present in the Thyroid Parenchyma - Observational Research
Actual Study Start Date : July 5, 2018
Actual Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • thyroid disease requiring surgery

Exclusion Criteria:

  • acute or chronic infection at remote sites
  • treated with antibiotics over the last 3 months

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): NCT04552496


Contacts
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Contact: Sergiusz Durowicz, MD, PhD +48226217173 sdurowicz@wp.pl
Contact: Waldemar L. Olszewski, MD, PhD waldemar.l.olszewski@gmail.com

Locations
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Poland
Department of General, Oncological and Gastrointestinal Surgery, Centre of Postgraduate Medical Education Recruiting
Warsaw, Poland, 00-416
Contact: Sergiusz Durowicz, MD, PhD    +48226217173    sdurowicz@wp.pl   
Principal Investigator: Sergiusz Durowicz, MD, PhD         
Principal Investigator: Wiesław Tarnowski, MD, PhD         
Department of Applied Physiology, Mossakowski Medical Research Centre, Polish Academy of Sciences Recruiting
Warsaw, Poland, 02-106
Contact: Marzanna Zaleska, PhD       mzaleska34@gmail.com   
Principal Investigator: Marzanna Zaleska, PhD         
Sponsors and Collaborators
Centre of Postgraduate Medical Education
Investigators
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Principal Investigator: Sergiusz Durowicz, MD, PhD Centre of Postgraduate Medical Education, Warsaw, Poland
Principal Investigator: Marzanna Zaleska, PhD Mossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw, Poland
Principal Investigator: Waldemar L. Olszewski, MD, PhD Central Clinical Hospital Ministry Interior Administration, Warsaw, Poland
Principal Investigator: Wiesław Tarnowski, Md, PhD Centre of Postgraduate Medical Education, Warsaw, Poland
Principal Investigator: Ewa Swoboda-Kopeć, MD, PhD Medical University of Warsaw, Warsaw, Poland
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Responsible Party: Sergiusz Durowicz, Principal Investigator, Centre of Postgraduate Medical Education
ClinicalTrials.gov Identifier: NCT04552496    
Other Study ID Numbers: 85/PB/2018
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

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