GBSIPET-GBSNCT04871035
Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)
An observational study of GBS, run by University of Ulm at 1 site in Germany.
Trial summary
This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GBS
- What is being tested?
- Immunoadsorption and Plasma Exchange
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 28 Apr 2021to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients diagnosed with Guillain-Barré syndrome (GBS) who are treated with either plasma exchange or immunoadsorption in the Department of Neurology, University of Ulm.
Who may be able to join
- Diagnosis of Guillain-Barré Syndrome according to the diagnostic criteria proposed by Doorn et al. (Clinical features, pathogenesis, and treatment of Guillain-Barré syndrome, Lancet neurology 2008)
- age 18 years or above
Who cannot join
- Clinical or laboratory (C-reactive protein 20 mg/l or above, or evidence of nitrite-positive urinary tract infection) evidence of manifest systemic infection
- Intake of angiotensin converting enzyme inhibitor within1 weeks before first treatment
- Other contraindications against immunoadsorption or plasma exchange
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, 89081
Albert C Ludolph, MD, Prof., +49-731-177- ext. 1200, albert.ludolph@rku.de
Albert C Ludolph, MD, Prof.
About this study
This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.
- Conditions
- GBS
- Being tested
- Immunoadsorption, Plasma Exchange
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunoadsorptionDevice
1 cycle, consisting of 5 sessions on 5 consecutive days with processing of the 0.7-fold individual plasma volume (maximum 2.5 l) each days with tryptophan adsorbers.
Plasma ExchangeDevice
1 cycle, consisting of 5 sessions on 5 consecutive days with exchange of 0.7-fold plasma volume (maximum 2.5 l) each day with albumin solution as volume replacement solution.
| Study group | Role | What they receive |
|---|---|---|
| Immunoadsorption | Not described Receives: Device: Immunoadsorption | |
| Plasma Exchange | Not described Receives: Device: Plasma Exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score
Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted
Measured: 2 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
Standard clinical score for inflammatory neuropathies.
Measured: 2 weeks
Oxford Muscle Strength Score (Medical Research Council, MRC)
Standard clinical score for evaluating muscle strength / paresis. Muscle strength will be measured on a scale between 0 (no movement) and 5 (full strength) on 8 pre-defined muscles (one proximal and one distal muscle at each extremity).
Measured: 2 weeks
Vibration Score
Standard clinical score for evaluation of vibration sensitivity on a scale between 0 and 8, using a 256 tuning fork at 4 predefined spots (processus styloideus radii and malleolus lateralis on both sides).
Measured: 2 weeks
Secondary outcomes (24)
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score
Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted
Measured: 1, 3, and 5 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
Standard clinical score for inflammatory neuropathies.
Measured: 1, 3, and 5 weeks
Oxford Muscle Strength Score (Medical Research Council, MRC)
Standard clinical score for evaluating muscle strength / paresis. Muscle strength will be measured on a scale between 0 (no movement) and 5 (full strength) on 8 pre-defined muscles (one proximal and one distal muscle at each extremity).
Measured: 1, 3, and 5 weeks
Vibration Score
Standard clinical score for evaluation of vibration sensitivity on a scale between 0 and 8, using a 256 tuning fork at 4 predefined spots (processus styloideus radii and malleolus lateralis on both sides).
Measured: 1, 3, and 5 weeks
Hughes Score
Standard clinical score to quantify disability in Guillain-Barré syndrome
Measured: 1, 2, 3, and 5 weeks
Pain
Pain quantified on a visual analog scale between 0 (no pain) and 10 (maximum pain).
Measured: 1, 2, 3, and 5 weeks
N20
N20 latency of nervus medianus (both sides) as measured by somatosensory evoked potentials (SEPs)
Measured: 2 and 5 weeks
P40
P40 latency of nervus tibialis (both sides) as measured by somatosensory evoked potentials
Measured: 2 and 5 weeks
Nerve Conduction Velocity
Nerve conduction velocity of clinically affected nerves as measured by electroneurography (ENG)
Measured: 2 and 5 weeks
Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)
Quality of Life Scale
Measured: 1, 2, 3, and 5 weeks
Immunoglobulin A in serum
Immunoglobulin A serum concentration
Measured: 1, 2, 3, and 5 weeks
Immunoglobulin A in cerebrospinal fluid (CSF)
Immunoglobulin A concentration in cerebrospinal fluid
Measured: 2 weeks
Immunoglobulin G in serum
Immunoglobulin G serum concentration
Measured: 1, 2, 3, and 5 weeks
Immunoglobulin G in cerebrospinal fluid (CSF)
Immunoglobulin G concentration in cerebrospinal fluid
Measured: 2 weeks
Immunoglobulin M in serum
Immunoglobulin M serum concentration
Measured: 1, 2, 3, and 5 weeks
Immunoglobulin M in cerebrospinal fluid (CSF)
Immunoglobulin M concentration in cerebrospinal fluid
Measured: 2 weeks
Interleukin-1
Interleukin-1 serum concentration
Measured: 1, 2, 3, and 5 weeks
Interleukin-6
Interleukin-6 serum concentration
Measured: 1, 2, 3, and 5 weeks
Anti-GM1 antibodies
Anti-GM1 antibody serum levels
Measured: 1, 2, 3, and 5 weeks
Anti-GQ1b
Anti-GQQ1b antibody serum levels
Measured: 1, 2, 3, and 5 weeks
Neurofilament light chain (NfL) serum
Neurofilament light chain (NfL) serum levels
Measured: 1, 2, 3, and 5 weeks
Neurofilament light chain (NfL) in cerebrospinal fluid (CSF)
Neurofilament light chain (NfL) levels in cerebrospinal fluid (CSF)
Measured: 2 weeks
Safety and Tolerability
Kind and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 1, 2, 3, and 5 weeks
Therapeutic Response
Share of patients with at least 20% improvement in CIDP score
Measured: 1, 2, 3, and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start28 Apr 2021
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GBSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- DiaMed GmbH
- Responsible party
- Principal investigator, Albert Christian Ludolph, Prof., University of Ulm
- Investigators
- Johannes Dorst, Prof, Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871035
- Sponsor's protocol ID
- IPET-GBS 1.2
- Acronym
- IPET-GBS
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figures), as well as the study protocol will be available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at https://www.uniklinik-ulm.de/neurologie.html.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)
- ClinicalTrials.gov ID
- NCT04871035
- Acronym / sponsor ID
- IPET-GBS / IPET-GBS 1.2
- Conditions
- GBS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- DiaMed GmbH
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunoadsorption | – | Device: Immunoadsorption |
| Plasma Exchange | – | Device: Plasma Exchange |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients diagnosed with Guillain-Barré syndrome (GBS) who are treated with either plasma exchange or immunoadsorption in the Department of Neurology, University of Ulm.
Key inclusion criteria (2 listed)
- Diagnosis of Guillain-Barré Syndrome according to the diagnostic criteria proposed by Doorn et al. (Clinical features, pathogenesis, and treatment of Guillain-Barré syndrome, Lancet neurology 2008)
- age 18 years or above
Key exclusion criteria (3 listed)
- Clinical or laboratory (C-reactive protein 20 mg/l or above, or evidence of nitrite-positive urinary tract infection) evidence of manifest systemic infection
- Intake of angiotensin converting enzyme inhibitor within1 weeks before first treatment
- Other contraindications against immunoadsorption or plasma exchange
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunoadsorption1 cycle, consisting of 5 sessions on 5 consecutive days with processing of the 0.7-fold individual plasma volume (maximum 2.5 l) each days with tryptophan adsorbers. | Device | Immunoadsorption |
| Plasma Exchange1 cycle, consisting of 5 sessions on 5 consecutive days with exchange of 0.7-fold plasma volume (maximum 2.5 l) each day with albumin solution as volume replacement solution. | Device | Plasma Exchange |
Primary outcome
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score
Time frame: 2 weeks
Combined score consisting of Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Oxford muscle strength score, and vibration score, equally weighted
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
Time frame: 2 weeks
Standard clinical score for inflammatory neuropathies.
Oxford Muscle Strength Score (Medical Research Council, MRC)
Time frame: 2 weeks
Standard clinical score for evaluating muscle strength / paresis. Muscle strength will be measured on a scale between 0 (no movement) and 5 (full strength) on 8 pre-defined muscles (one proximal and one distal muscle at each extremity).
Vibration Score
Time frame: 2 weeks
Standard clinical score for evaluation of vibration sensitivity on a scale between 0 and 8, using a 256 tuning fork at 4 predefined spots (processus styloideus radii and malleolus lateralis on both sides).
24 secondary outcomes
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score
Time frame: 1, 3, and 5 weeks
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score
Time frame: 1, 3, and 5 weeks
Oxford Muscle Strength Score (Medical Research Council, MRC)
Time frame: 1, 3, and 5 weeks
Vibration Score
Time frame: 1, 3, and 5 weeks
Hughes Score
Time frame: 1, 2, 3, and 5 weeks
Pain
Time frame: 1, 2, 3, and 5 weeks
N20
Time frame: 2 and 5 weeks
P40
Time frame: 2 and 5 weeks
Nerve Conduction Velocity
Time frame: 2 and 5 weeks
Euro Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)
Time frame: 1, 2, 3, and 5 weeks
Immunoglobulin A in serum
Time frame: 1, 2, 3, and 5 weeks
Immunoglobulin A in cerebrospinal fluid (CSF)
Time frame: 2 weeks
Immunoglobulin G in serum
Time frame: 1, 2, 3, and 5 weeks
Immunoglobulin G in cerebrospinal fluid (CSF)
Time frame: 2 weeks
Immunoglobulin M in serum
Time frame: 1, 2, 3, and 5 weeks
Immunoglobulin M in cerebrospinal fluid (CSF)
Time frame: 2 weeks
Interleukin-1
Time frame: 1, 2, 3, and 5 weeks
Interleukin-6
Time frame: 1, 2, 3, and 5 weeks
Anti-GM1 antibodies
Time frame: 1, 2, 3, and 5 weeks
Anti-GQ1b
Time frame: 1, 2, 3, and 5 weeks
Neurofilament light chain (NfL) serum
Time frame: 1, 2, 3, and 5 weeks
Neurofilament light chain (NfL) in cerebrospinal fluid (CSF)
Time frame: 2 weeks
Safety and Tolerability
Time frame: 1, 2, 3, and 5 weeks
Therapeutic Response
Time frame: 1, 2, 3, and 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figures), as well as the study protocol will be available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at https://www.uniklinik-ulm.de/neurologie.html.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johannes Dorst, Prof principal investigator
University of Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GBS, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Dorst, Prof (+49 731 177 5285, johannes.dorst@uni-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Score (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.