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

Bacteria Infection Mechanism Clinical Trial

Official title:

The Thyroidectomy Wound Inflammation Can be Caused by Microbes Present in the Thyroid Parenchyma - Observational Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04552496
• Other study ID #: 85/PB/2018
• Status: Recruiting
• Start date: July 5, 2018
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2020
• Source: Centre of Postgraduate Medical Education
• Contact: Sergiusz Durowicz, MD, PhD
• Phone: +48226217173
• Email: sdurowicz[@]wp.pl
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• thyroid disease requiring surgery

Exclusion Criteria:

• acute or chronic infection at remote sites

• treated with antibiotics over the last 3 months

Related Conditions & MeSH terms

• Bacteria Infection Mechanism

Locations

Country	Name	City	State
Poland	Department of Applied Physiology, Mossakowski Medical Research Centre, Polish Academy of Sciences	Warsaw
Poland	Department of General, Oncological and Gastrointestinal Surgery, Centre of Postgraduate Medical Education	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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