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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04552496
Other study ID # 85/PB/2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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