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CompletedNCT07112677Updated Aug 8, 2025

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

An observational study in Brucellosis and Low Back Pain, sponsored by Elham Ahmed Hassan. Completed at 2 sites in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-08.

Sponsored by Elham Ahmed Hassan · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Brucellosis
  • Low Back Pain

Keywords

  • brucella antibodies
  • low back pain
03

In context

Brucellosis

15 studies on the registry are indexed under Brucellosis; 6 are open to participants now.

Browse Brucellosis studies →

Lead sponsor

Elham Ahmed Hassan is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults with high risk of Brucella exposure (e.g., animal contact or consumption of unpasteurized dairy products), including patients presenting with non-specific low back pain and healthy controls without back pain. Participants were recruited from outpatient clinics and inpatient wards at Assiut University Hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Evidence of tuberculosis (Pott's disease)
  • Evidence of septic spondylitis
  • Known bone lesions
  • Known degenerative or rheumatologic spinal diseases
  • History of prior spinal surgery or trauma
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

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

    Diagnostic Test: Brucella Antibody Testing (ELISA)

Interventions

  • Diagnostic testBrucella 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.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: February 2024 to February 2025

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

    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.

    Time frame: At enrollment

07

Study locations

2 sites
  • Assiut University Hospital
    Asyut, 71515, Egypt
  • Assiut University
    Asyut, 71515, Egypt
08

References and documents

Individual participant data

Plan to share: No — I do not have specific consent from participants to share individual-level data.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07112677
Lead sponsor
Elham Ahmed Hassan
Responsible party
Elham Ahmed Hassan (Professor of Tropical Medicine and Gastroenterology, Assiut University, Assiut University) — Sponsor-investigator
First posted
Aug 8, 2025
Start date
Feb 1, 2024
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025
Last update
Aug 8, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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