UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061349 |
|---|---|
| Receipt number | R000070188 |
| Scientific Title | Analysis of Campylobacter cell wall glycan-recognizing antibodies associated with the pathogenesis of Guillain-Barre syndrome in human serum |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/22 12:03:42 |
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Basic information
Public title
Analysis of Campylobacter glycan-recognizing antibodies related to Guillain-Barre syndrome in human serum
Acronym
GBS antibody study
Scientific Title
Analysis of Campylobacter cell wall glycan-recognizing antibodies associated with the pathogenesis of Guillain-Barre syndrome in human serum
Scientific Title:Acronym
GBS-Campy Ab study
Region
| Japan |
Condition
Condition
Guillain-Barre syndrome
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize antibodies against Campylobacter lipooligosaccharide(LOS) and gangliosides in human serum, and to determine the types and titers of antibodies associated with the development of Guillain-Barre syndrome.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of anti-ganglioside antibodies
Prevalence of anti-Campylobacter LOS antibodies
Comparison between GBS patients and non-GBS outpatient controls
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with a confirmed diagnosis of Guillain-Barre syndrome (GBS)
Patients suspected of Guillain-Barre syndrome
Neurology outpatients without GBS
Key exclusion criteria
Individuals who do not provide informed consent to participate in the study
Individuals from whom adequate serum samples cannot be obtained or whose samples are of insufficient quality
Individuals who are receiving immunosuppressive therapy (e.g., high-dose corticosteroids or immunosuppressive agents) that may affect antibody measurements, as judged by the principal investigator
Individuals deemed inappropriate for inclusion in the study by the principal investigator for any other reason
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shimizu |
| Middle name | |
| Last name | Takeshi |
Organization
Chiba University
Division name
Graduate School of Medicine
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-226-2048
tshimizu@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Shimizu |
| Middle name | |
| Last name | Takeshi |
Organization
Chiba University
Division name
Graduate School of Medicine
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-226-2048
Homepage URL
tshimizu@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of the Ethics Committee for Observational Studies, Clinical Trial Unit, Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba
Tel
043-311-3023
hsp-kansaturinri@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study has been approved by the ethics committee and is currently in the preparation phase prior to initiation.
Management information
Registered date
| 2026 | Year | 04 | Month | 22 | Day |
Last modified on
| 2026 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070188
