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

NCT ID: NCT04552496

Last Updated: 2020-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-05

Study Completion Date

2022-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Bacteria Infection Mechanism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* thyroid disease requiring surgery

Exclusion Criteria

* acute or chronic infection at remote sites
* treated with antibiotics over the last 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre of Postgraduate Medical Education

OTHER

Sponsor Role lead

Responsible Party

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Sergiusz Durowicz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sergiusz Durowicz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre of Postgraduate Medical Education, Warsaw, Poland

Marzanna Zaleska, PhD

Role: PRINCIPAL_INVESTIGATOR

Mossakowski Medical Research Centre, Polish Academy of Sciences, Warsaw, Poland

Waldemar L. Olszewski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Central Clinical Hospital Ministry Interior Administration, Warsaw, Poland

Wiesław Tarnowski, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre of Postgraduate Medical Education, Warsaw, Poland

Ewa Swoboda-Kopeć, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw, Warsaw, Poland

Locations

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Department of General, Oncological and Gastrointestinal Surgery, Centre of Postgraduate Medical Education

Warsaw, , Poland

Site Status RECRUITING

Department of Applied Physiology, Mossakowski Medical Research Centre, Polish Academy of Sciences

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Sergiusz Durowicz, MD, PhD

Role: CONTACT

+48226217173

Waldemar L. Olszewski, MD, PhD

Role: CONTACT

Facility Contacts

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Sergiusz Durowicz, MD, PhD

Role: primary

+48226217173

Marzanna Zaleska, PhD

Role: primary

Other Identifiers

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85/PB/2018

Identifier Type: -

Identifier Source: org_study_id

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