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

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

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Key information

Conditions

Brucellosis Back Pain Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University, Asyut, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brucella Antibody Testing (ELISA)

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.

Primary outcomes

Prevalence of Brucella Antibodies in High-Risk Patients with Low Back Pain

Time frame: February 2024 to February 2025

The presence of Brucella antibodies (IgG, IgM, and IgA) in serum was assessed using the SERION ELISA classic Brucella kit. A positive result indicates prior or current exposure to Brucella species. The outcome compares the proportion of seropositive individuals between patients with low back pain and matched controls.
Prevalence of Brucella Antibodies in High-Risk Patients with Low Back Pain

Time frame: At enrollment

The presence of Brucella antibodies (IgG, IgM, and IgA) in serum was assessed using the SERION ELISA classic Brucella kit. A positive result indicates prior or current exposure to Brucella species. The outcome compares the proportion of seropositive individuals between patients with low back pain and matched controls.

Sponsors and collaborators

Lead sponsor

Elham Ahmed Hassan

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 8, 2025
Registry last updated: Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed