Blood Biomarkers for Prognostic Stratification in Guillain-Barré Syndrome

November 10, 2026 updated by: Jose Juan Antonio Ibarra Arias, Anahuac University

Integration of a Blood Biomarker Panel for Prognostic Stratification in Guillain-Barré Syndrome: A Mexico-Spain Collaborative Study (BioGBS)

Guillain-Barré syndrome (GBS) is an acute immune-mediated peripheral neuropathy characterized by substantial variability in clinical severity, functional recovery, and pain outcomes. The lack of validated and accessible prognostic biomarkers limits early risk stratification and individualized rehabilitation strategies.

This observational, longitudinal, retrospective and prospective study aims to evaluate a panel of five blood biomarkers (EGR1, EGR2, GBP1, miR-29c, and Piccolo) and determine their association with functional recovery, pain trajectories, and neurophysiological characteristics in patients with GBS.

The study will include at least 70 patients with GBS and 70 healthy controls. Patients will undergo longitudinal clinical and molecular assessments across different disease stages, whereas healthy controls will provide a single blood sample for reference measurements. Gene and microRNA expression will be quantified using quantitative reverse transcription polymerase chain reaction (qRT-PCR), and serum Piccolo concentrations will be assessed using ELISA or validated immunoassays.

Clinical assessments will include the GBS Disability Scale, Medical Research Council (MRC) Sum Score, Functional Independence Measure (FIM), and validated pain questionnaires. Molecular and clinical data will be integrated using multivariable statistical analyses to identify prognostic molecular signatures and develop predictive models.

The project also aims to support external validation in Mexican populations through international collaboration with Spanish research institutions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Guillain-Barré syndrome (GBS) is an acute immune-mediated polyradiculoneuropathy affecting the peripheral nervous system. It is characterized by heterogeneous clinical presentations, including progressive weakness, sensory disturbances, pain, autonomic dysfunction, and, in severe cases, respiratory failure. Although immunomodulatory treatments and multidisciplinary rehabilitation have improved clinical outcomes, predicting individual recovery trajectories remains challenging.

Current prognostic assessment relies primarily on clinical and electrophysiological parameters, which may not adequately capture the molecular mechanisms underlying immune activation, peripheral nerve injury, remyelination, and functional recovery.

Previous investigations conducted by the research group identified differential expression of EGR1, EGR2, GBP1, and miR-29c in peripheral blood mononuclear cells (PBMCs) obtained from patients with GBS. Differential serum concentrations of the presynaptic protein Piccolo were also identified, suggesting their potential relevance as molecular indicators of disease progression and recovery.

The BioGBS study aims to validate these five candidate biomarkers through longitudinal analysis and integration with clinical, functional, pain-related, and neurophysiological data.

The study will employ an observational, retrospective and prospective longitudinal design, including at least 70 patients diagnosed with GBS and 70 healthy controls. Patients will be assessed at four clinically defined stages: initial diagnosis before immunomodulatory treatment (T0), maximum clinical severity or nadir (T1), onset of sustained functional recovery (T2), and advanced recovery or discharge from rehabilitation (T3). Healthy controls will undergo a single baseline molecular assessment.

Gene expression levels of EGR1, EGR2, GBP1, and miR-29c will be quantified in PBMCs using qRT-PCR. Serum Piccolo concentrations will be determined using ELISA or validated immunoassays.

Functional outcomes will be assessed using the GBS Disability Scale, MRC Sum Score, and FIM. Pain severity and interference will be evaluated using the Brief Pain Inventory-Short Form (BPI-SF), while neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI). Electrophysiological findings will be incorporated when available.

Statistical analyses will include longitudinal mixed-effects models, multivariable regression, principal component analysis, unsupervised clustering, and receiver operating characteristic curve analysis. Predictive models will be developed to identify molecular signatures associated with favorable or unfavorable functional recovery and persistent pain. Internal cross-validation and correction for multiple comparisons will be performed when appropriate.

The study will integrate the existing Spanish TOSGB biological collection and collaborative research activities in Mexico. External validation in Mexican patients is planned to evaluate the transferability of the prognostic biomarkers across different populations and healthcare settings.

No experimental treatment will be assigned. All participants with GBS will receive standard medical care and rehabilitation according to routine clinical practice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Mexico
      • Mexico City, Mexico
        • Recruiting
        • Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez
        • Contact:
  • Spain
      • Toledo, Spain
        • Recruiting
        • Hospital Nacional de Parapléjicos
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of patients aged 16 years or older with clinically and neurophysiologically confirmed Guillain-Barré syndrome, recruited from participating hospitals in Spain and Mexico. A comparison group of healthy volunteers aged 18 years or older, with a comparable age and sex distribution, will be included to establish reference biomarker measurements. Patients will undergo longitudinal follow-up, whereas healthy controls will undergo a single baseline assessment.

Description

Inclusion Criteria:

  • Diagnosis of Guillain-Barré syndrome based on clinical and neurophysiological criteria.
  • Age 16 years or older.
  • Availability of biological samples for molecular analysis.
  • Written informed consent.
  • Availability of longitudinal clinical data.

Exclusion Criteria:

  • Alternative diagnosis explaining the neurological manifestations.
  • Concomitant active autoimmune disease.
  • Severe systemic infection.
  • Previous unrelated immunosuppressive treatment.
  • Incomplete clinical data or absence of informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: OTHER

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients With Guillain-Barré Syndrome

Patients with clinically and neurophysiologically confirmed GBS undergoing longitudinal molecular, functional, pain-related, and neurophysiological assessments across different stages of the disease.
Diagnostic test: Blood Biomarker Panel Assessment (EGR1, EGR2, GBP1, miR-29c, and Piccolo)

Peripheral blood samples will be collected from patients with Guillain-Barré syndrome and healthy controls to evaluate a panel of molecular biomarkers. Expression levels of EGR1, EGR2, GBP1, and miR-29c will be quantified in peripheral blood mononuclear cells using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Serum Piccolo concentrations will be measured using ELISA or validated immunoassays. Patients with Guillain-Barré syndrome will undergo longitudinal assessments at predefined clinical stages, whereas healthy controls will undergo a single baseline assessment. No experimental treatment will be administered, and routine clinical management will remain unchanged.
Healthy Controls

Healthy individuals without neurological or autoimmune disorders, selected to provide reference measurements for the candidate blood biomarkers. Controls will undergo a single baseline blood sample collection.
Diagnostic test: Blood Biomarker Panel Assessment (EGR1, EGR2, GBP1, miR-29c, and Piccolo)

Peripheral blood samples will be collected from patients with Guillain-Barré syndrome and healthy controls to evaluate a panel of molecular biomarkers. Expression levels of EGR1, EGR2, GBP1, and miR-29c will be quantified in peripheral blood mononuclear cells using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Serum Piccolo concentrations will be measured using ELISA or validated immunoassays. Patients with Guillain-Barré syndrome will undergo longitudinal assessments at predefined clinical stages, whereas healthy controls will undergo a single baseline assessment. No experimental treatment will be administered, and routine clinical management will remain unchanged.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Guillain-Barré Syndrome Disability Score
Time Frame: Baseline (Day 1), up to 6 months, and up to 12 months after baseline

Change in functional disability measured using the GBS Disability Scale, ranging from 0 (normal health) to 6 (death). Higher scores indicate greater disability. Longitudinal changes will be assessed in relation to blood biomarker expression.

0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.

All assessment intervals are calculated from T0 (baseline). Clinical stages are determined according to the patient's disease progression and recovery status.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline
Change in Muscle Strength Assessed by the MRC Sum Score
Time Frame: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Change in muscle strength assessed using the Medical Research Council Sum Score, ranging from 0 to 60. Higher scores indicate better muscle strength. Longitudinal changes will be evaluated in association with molecular biomarker profiles.

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Functional Independence Measure Score
Time Frame: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Functional independence measured using the Functional Independence Measure (FIM), ranging from 18 to 126. Higher scores indicate greater independence in activities of daily living.

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.
Change in Pain Intensity Assessed by the Brief Pain Inventory
Time Frame: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Change in pain intensity measured using the Brief Pain Inventory-Short Form (BPI-SF), on a scale from 0 to 10, with higher scores indicating greater pain intensity.

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.
Change in Pain Interference Assessed by the Brief Pain Inventory
Time Frame: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Change in the interference of pain with daily activities, measured using the BPI-SF on a scale from 0 to 10, with higher scores indicating greater interference.

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.
Change in Neuropathic Pain Symptom Inventory Score
Time Frame: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Change in neuropathic pain symptoms assessed using the Neuropathic Pain Symptom Inventory (NPSI), with a total score ranging from 0 to 100. Higher scores indicate greater neuropathic pain severity.

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.
Longitudinal Change in EGR1, EGR2, GBP1, and miR-29c Expression
Time Frame: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Relative expression of EGR1, EGR2, GBP1, and miR-29c in PBMCs measured using qRT-PCR and expressed as 2^-ΔCt or 2^-ΔΔCt. Associations with clinical recovery trajectories will be analyzed.

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.
Longitudinal Change in Serum Piccolo Concentration
Time Frame: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Serum Piccolo concentration quantified using ELISA or a validated immunoassay and expressed in pg/mL or ng/mL, depending on assay specifications.

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.
Prognostic Performance of the Combined Blood Biomarker Panel
Time Frame: Baseline (Day 1), up to 6 months, and up to 12 months after baseline.

Discriminative performance of a combined panel comprising EGR1, EGR2, GBP1, miR-29c, and Piccolo for identifying unfavorable functional recovery, evaluated using the area under the receiver operating characteristic curve (AUC).

T0 (Baseline): Day 1, before initiation of immunotherapy.

T1 (Nadir or prolonged plateau): Up to 6 months after baseline.

T2 (Onset of clinical recovery): Up to 12 months after baseline.

T3 (Advanced recovery or neurorehabilitation discharge): Up to 12 months after baseline.
Baseline (Day 1), up to 6 months, and up to 12 months after baseline.
Requirement for Mechanical Ventilation
Time Frame: From baseline (Day 1) through 12 months after baseline.

Proportion of patients requiring invasive mechanical ventilation during the acute phase of GBS and duration of ventilatory support when applicable.
From baseline (Day 1) through 12 months after baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anahuac University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Nacional de Parapléjicos de Toledo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 241/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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