Seroprevalence of Brucella Antibodies in High-Risk Patients With Low Back Pain: A Case-Control Study

NCT ID: NCT07112677

Last Updated: 2025-08-08

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

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-02-28

Brief Summary

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The goal of this observational case-control study is to assess the presence of Brucella antibodies in patients with low back pain who are at high risk for brucellosis exposure, such as those with animal contact or consumption of unpasteurized dairy products. The main question it aims to answer is:

Is there a significant association between Brucella seropositivity and low back pain in high-risk individuals?

Researchers will compare patients with low back pain to age- and sex-matched healthy controls without back pain but with similar exposure risks, to see if Brucella antibodies are more frequent in the patient group.

Participants will:

Undergo a detailed clinical history and physical examination

Provide blood samples for serological testing using ELISA for Brucella IgG/IgM/IgA

Be evaluated for other symptoms such as fever, fatigue, and joint pain

Detailed Description

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Conditions

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Brucellosis Low Back Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1 (Patients): Low Back Pain Group, Group 2 (Controls): Control Group

Brucella Antibody Testing (ELISA)

Intervention Type DIAGNOSTIC_TEST

Serological testing for Brucella antibodies using the SERION ELISA classic Brucella IgG/IgM/IgA kit (Institut Virion\\Serion GmbH, Würzburg, Germany). The test detects Brucella-specific IgG, IgM, and IgA antibodies in serum samples to assess current or past exposure. All samples were processed and interpreted according to the manufacturer's instructions. This diagnostic intervention was used for both the low back pain group and the control group.

Interventions

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Brucella Antibody Testing (ELISA)

Serological testing for Brucella antibodies using the SERION ELISA classic Brucella IgG/IgM/IgA kit (Institut Virion\\Serion GmbH, Würzburg, Germany). The test detects Brucella-specific IgG, IgM, and IgA antibodies in serum samples to assess current or past exposure. All samples were processed and interpreted according to the manufacturer's instructions. This diagnostic intervention was used for both the low back pain group and the control group.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adults of any sex at high risk of Brucella exposure (e.g., contact with livestock or consumption of unpasteurized dairy products)
* Patients presenting with non-specific low back pain
* Willing and able to provide informed consen

Exclusion Criteria

* Evidence of tuberculosis (Pott's disease)
* Evidence of septic spondylitis
* Known metastatic bone lesions
* Known degenerative or autoimmune rheumatologic spinal diseases
* History of prior spinal surgery or trauma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Elham Ahmed Hassan

OTHER

Sponsor Role lead

Responsible Party

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Elham Ahmed Hassan

Professor of Tropical Medicine and Gastroenterology, Assiut University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Assiut University Hospital

Asyut, , Egypt

Site Status

Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AUN-BRU-LBP-2024

Identifier Type: -

Identifier Source: org_study_id

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