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

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.

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 Overview

• Status: Unknown
• Conditions: Bacteria Infection Mechanism

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Sergiusz Durowicz, MD, PhD; Phone Number: +48226217173; Email: sdurowicz@wp.pl
• Study Contact Backup: Name: Waldemar L. Olszewski, MD, PhD; Email: waldemar.l.olszewski@gmail.com

Study Locations

• Poland
  • Warsaw, Poland, 00-416
    • Recruiting
    • Department of General, Oncological and Gastrointestinal Surgery, Centre of Postgraduate Medical Education
    • Contact: Sergiusz Durowicz, MD, PhD; Phone Number: +48226217173; Email: sdurowicz@wp.pl
    • Principal Investigator: Sergiusz Durowicz, MD, PhD
    • Principal Investigator: Wiesław Tarnowski, MD, PhD
  • Warsaw, Poland, 02-106
    • Recruiting
    • Department of Applied Physiology, Mossakowski Medical Research Centre, Polish Academy of Sciences
    • Contact: Marzanna Zaleska, PhD; Email: mzaleska34@gmail.com
    • Principal Investigator: Marzanna Zaleska, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• thyroid disease requiring surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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).	3 days

Collaborators and Investigators

• Sponsor: Centre of Postgraduate Medical Education
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 5, 2018
• Primary Completion (ACTUAL): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (ACTUAL): September 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 85/PB/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No