Pilot case-control study: NK-cell activation in PTLDS

Pilot case-control study: an analysis of NK-cell recruitment and activation in Post-treatment Lyme disease syndrome (PTLDS) - NK-cell activation in PTLDS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON61143

Enrollment

Registered

2026-01-26

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-treatment Lyme disease syndrome PTLDS

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: PTLDSIn order to be eligible to participate in this study, a participant must meet all of the following criteria:Physician documented case of treated Lyme disease (following CDC criteria with confirmed laboratory evidence)Onset of at least one of the following key symptoms < 6 months following treatment of Lyme disease, that lasts > 6 months:FatigueMusculoskeletal painCognitive dysfunctionSymptoms cause significant dysfunction in daily functioning Recovered controlsIn order to be eligible to participate in this study, a participant must meet all of the following criteria:Physician documented case of treated Lyme disease (following CDC criteria with confirmed laboratory evidence)Normal recovery from their Lyme disease

Exclusion criteria

Exclusion criteria: PTLDSA potential participant who meets any of the following criteria will be excluded from participation in this study:Symptoms can be explained by an ongoing infection and/or concomitant illness (e.g. depression, rheumatologic disease, etc.) Recovered controlA potential participant who meets any of the following criteria will be excluded from participation in this study:Symptoms of PTLDSPresence of concomitant illness that would serve as an exclusion criteria for PTLDS

Design outcomes

Primary

Measure	Time frame
As measured with flow cytometry in whole blood: NK-cell populations (CD16/CD56 and CD3/CD45/CD56), activation (HLA-DR), exhaustion (PD-1/CD38), homing capabilities (CXCR5, CXCR4, CXCR3, CCR7, CCR6, CCR5, CCR4). As measured with flow cytometry in CD56+ Magnetic Cell Separation (MACS) isolated NK-cells from whole blood: cytotoxicity (NKp46, NKp30), activation, and cytokine production (DNAM-1), stress response (NKG2D), memory (CD57, NKG2C, and CD94), inhibitory function (NKG2A, ILT2, and KIR2DL2/3), and NK-cell activation ( CD107a and perforin release) after stimulation (IL-2/IL-15, IFNa, and K562 cells).	—

Measure

Time frame

As measured with flow cytometry in whole blood: NK-cell populations (CD16/CD56 and CD3/CD45/CD56), activation (HLA-DR), exhaustion (PD-1/CD38), homing capabilities (CXCR5, CXCR4, CXCR3, CCR7, CCR6, CCR5, CCR4). As measured with flow cytometry in CD56+ Magnetic Cell Separation (MACS) isolated NK-cells from whole blood: cytotoxicity (NKp46, NKp30), activation, and cytokine production (DNAM-1), stress response (NKG2D), memory (CD57, NKG2C, and CD94), inhibitory function (NKG2A, ILT2, and KIR2DL2/3), and NK-cell activation ( CD107a and perforin release) after stimulation (IL-2/IL-15, IFNa, and K562 cells).

—

Secondary

Measure	Time frame
As measured with DSQ-2 and SF-36 questionnaires: ME/CFS case criteria which are generally accepted as a measure for Post-acute Infection Syndromes (PAIS) like PTLDS.	—

Countries

Netherlands

Contacts

Public ContactRPH Raijmakers

Radboud Universitair Medisch Centrum

ruud.raijmakers@radboudumc.nl024 361 8819

Outcome results