Postherpetic Neuralgia ( PHN )NCT07038707
Early Screening Markers of Herpes Zoster Neuralgia
An observational study of Postherpetic Neuralgia ( PHN ) and Lymphatic System Disorder, run by Tongji Hospital.
Trial summary
Herpes zoster (HZ), especially postherpetic neuralgia, is one of the most typical types of clinical neuralgia. The incidence rate of HZ in China is approximately 7.7%. Among them, 29.8% of HZ patients eventually develop PHN. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postherpetic Neuralgia ( PHN ), Lymphatic System Disorder
- What is being tested?
- Extract the serum and feces of the patients for standard screening of early biomarkers and Meningeal lymphatic vessel imaging
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Dec 2026
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals among patients with herpes zoster (HZ) who eventually develop PHN (according to the diagnostic criteria of PHN, such as persistent pain for ≥3 months)
Who may be able to join
- The definite diagnoses were PHN (disease course ≤ 1 month), PHN (1 month < disease course < 2 months), and PHN (disease course > 3 months); Age equal to 50 years old; Not accompanied by other chronic pain diseases; Sign the informed consent form.
Who cannot join
- There are underlying digestive system diseases such as irritable bowel syndrome and inflammatory bowel disease; There are obvious gastrointestinal discomfort symptoms such as diarrhea and abdominal distension; There is immunosuppression or autoimmune disease; Antibiotics, acid suppressants or drugs that interfere with the intestinal flora have been used within the past month; Have a history of mental illness or abuse of tobacco and alcohol (2 packs per day)
About this study
Official title: Research on the Identification of Early Screening Markers for Herpes Zoster Neuralgia Based on Intestinal Flora Analysis
Herpes zoster (HZ), especially postherpetic neuralgia, is one of the most typical types of clinical neuralgia. The incidence rate of HZ in China is approximately 7.7%. Among them, 29.8% of HZ patients eventually develop PHN. About 20% of PHN patients suffer from severe neuralgia for more than one year, or even ten years. It is worth noting that patients with neuralgia are prone to comorbidities such as depression, anxiety and sleep disorders, which seriously affect their work efficiency and quality of life. This is a great torment to both the patients and their families, and it also imposes a heavy burden on the medical system.
Professor Xiao Lizu, a collaborator of our team, has discovered in clinical practice that spinal cord electrical stimulation for HZ patients can significantly reduce the risk of developing PHN. Other therapies for reducing the risk of PHN include multiple parvertebral injections of local anesthetics/steroids, which require patients to return for repeated visits. Although these intervention measures have good effects, they may bring additional economic burdens to patients, treatment side effects and prolong their hospital stays. Therefore, they are not suitable for all patients. From this perspective, our development of early screening methods and selective non-pharmacological intervention only for high-risk patients will improve the overall treatment status of HZ, effectively reduce the incidence of PHN, and alleviate the burden on medical insurance and the medical system at the same time.
Read more
This project aims to conduct the following research by analyzing the intestinal flora of patients: identifying biomarkers with the ability to predict the risk of PHN in patients, constructing a machine learning classifier for risk prediction, and developing an early screening kit based on this.
Furthermore, traditional studies mostly focus on a single pathological link and lack systematic multi-dimensional analysis. In recent years, the cerebral lymphatic system, as a key pathway for the clearance of metabolic wastes in the brain, has attracted widespread attention. Furthermore, the role of the gut-brain axis in pain regulation has gradually been recognized. Therefore, it is of great scientific significance to integrate and explore the pathological mechanism of PHN from three dimensions: the lymphatic system, neuroinflammation, and intestinal flora.
This project assumes that patients with PHN have a pathological triad of "lymphoid dysfunction - neuroinflammatory activation - intestinal flora imbalance". The specific manifestations are as follows: Impaired lymphoid clearance function (decreased DTI-ALPS index and increased free water), activated systemic inflammatory response (elevated TNF-α and IL-6), and disordered intestinal flora structure (decreased α diversity and increased opportunistic pathogenic bacteria). The three interact with each other and have a synergistic effect, jointly participating in the pathogenesis of PHN.The expected outcome of this project may provide new options for pain management of the large group of neuralgia patients, improve their quality of life, and has great practicality and practical value.
- Being tested
- Extract the serum and feces of the patients for standard screening of early biomarkers, Meningeal lymphatic vessel imaging
- Keywords
- Intestinal flora, Inflammation, Lymphatic System Disorder, Postherpetic Neuralgia ( PHN )
- Medical subject headings
- Neuralgia, Postherpetic, Lymphatic Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extract the serum and feces of the patients for standard screening of early biomarkersOther
In this study, blood and fecal samples from patients with herpes and herpes neuralgia were collected for genomic sequencing of the gut microbiota and metabolome analysis, etc. Based on the principle of diffusion tensor imaging, by measuring the anisotropic diffusion of white matter around the corpus callosum at the horizontal level of the lateral ventricle body, the lymphatic system clearance function is quantified
Meningeal lymphatic vessel imagingOther
The functional changes of the cerebral lymphatic system in patients with PHN were detected by meningeal lymphatic vessel imaging
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group | Healthy individuals matched by age and gender (without a history of HZ or chronic pain diseases). Receives: Other: Extract the serum and feces of the patients for standard screening of early biomarkers; Other: Meningeal lymphatic vessel imaging | |
| PHN Group | Individuals among patients with herpes zoster (HZ) who eventually develop PHN (according to the diagnostic criteria of PHN, such as persistent pain for ≥3 months) Receives: Other: Extract the serum and feces of the patients for standard screening of early biomarkers; Other: Meningeal lymphatic vessel imaging | |
| HZ did not convert to the PHN group | Individuals among patients with herpes zoster who did not develop PHN (with complete remission of pain within 3 months). Receives: Other: Extract the serum and feces of the patients for standard screening of early biomarkers; Other: Meningeal lymphatic vessel imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
HZ biomarkers
DNA was extracted from fecal samples for metagenomic sequencing. Based on the metagenomic sequencing results, we will select the important biomarkers that can distinguish the subgroups of HZ patients
Measured: 1 week
Secondary outcomes (1)
Lymphatic system function
The lymphatic function of patients with PHN was evaluated through a meningeal lymphatic vessel imaging system
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic Neuralgia ( PHN )Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuebi Tian, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038707
- Sponsor's protocol ID
- TJ-IRB20250519
- Status last verified
- May 2025
- First submitted
- 18 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Identification of Early Screening Markers for Herpes Zoster Neuralgia Based on Intestinal Flora Analysis
- ClinicalTrials.gov ID
- NCT07038707
- Acronym / sponsor ID
- TJ-IRB20250519
- Keywords
- Intestinal flora, Inflammation, Lymphatic System Disorder, Postherpetic Neuralgia ( PHN )
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jun 2025 (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.
Herpes zoster (HZ), especially postherpetic neuralgia, is one of the most typical types of clinical neuralgia. The incidence rate of HZ in China is approximately 7.7%. Among them, 29.8% of HZ patients eventually develop PHN. About 20% of PHN patients suffer from severe neuralgia for more than one year, or even ten years. It is worth noting that patients with neuralgia are prone to comorbidities such as depression, anxiety and sleep disorders, which seriously affect their work efficiency and quality of life. This is a great torment to both the patients and their families, and it also imposes a heavy burden on the medical system.
Professor Xiao Lizu, a collaborator of our team, has discovered in clinical practice that spinal cord electrical stimulation for HZ patients can significantly reduce the risk of developing PHN. Other therapies for reducing the risk of PHN include multiple parvertebral injections of local anesthetics/steroids, which require patients to return for repeated visits. Although these intervention measures have good effects, they may bring additional economic burdens to patients, treatment side effects and prolong their hospital stays. Therefore, they are not suitable for all patients. From this perspective, our development of early screening methods and selective non-pharmacological intervention only for high-risk patients will improve the overall treatment status of HZ, effectively reduce the incidence of PHN, and alleviate the burden on medical insurance and the medical system at the same time.
This project aims to conduct the following research by analyzing the intestinal flora of patients: identifying biomarkers with the ability to predict the risk of PHN in patients, constructing a machine learning classifier for risk prediction, and developing an early screening kit based on this.
Furthermore, traditional studies mostly focus on a single pathological link and lack systematic multi-dimensional analysis. In recent years, the cerebral lymphatic system, as a key pathway for the clearance of metabolic wastes in the brain, has attracted widespread attention. Furthermore, the role of the gut-brain axis in pain regulation has gradually been recognized. Therefore, it is of great scientific significance to integrate and explore the pathological mechanism of PHN from three dimensions: the lymphatic system, neuroinflammation, and intestinal flora.
This project assumes that patients with PHN have a pathological triad of "lymphoid dysfunction - neuroinflammatory activation - intestinal flora imbalance". The specific manifestations are as follows: Impaired lymphoid clearance function (decreased DTI-ALPS index and increased free water), activated systemic inflammatory response (elevated TNF-α and IL-6), and disordered intestinal flora structure (decreased α diversity and increased opportunistic pathogenic bacteria). The three interact with each other and have a synergistic effect, jointly participating in the pathogenesis of PHN.The expected outcome of this project may provide new options for pain management of the large group of neuralgia patients, improve their quality of life, and has great practicality and practical value.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | – | Other: Extract the serum and feces of the patients for standard screening of early biomarkers, Other: Meningeal lymphatic vessel imagingHealthy individuals matched by age and gender (without a history of HZ or chronic pain diseases). |
| PHN Group | – | Other: Extract the serum and feces of the patients for standard screening of early biomarkers, Other: Meningeal lymphatic vessel imagingIndividuals among patients with herpes zoster (HZ) who eventually develop PHN (according to the diagnostic criteria of PHN, such as persistent pain for ≥3 months) |
| HZ did not convert to the PHN group | – | Other: Extract the serum and feces of the patients for standard screening of early biomarkers, Other: Meningeal lymphatic vessel imagingIndividuals among patients with herpes zoster who did not develop PHN (with complete remission of pain within 3 months). |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals among patients with herpes zoster (HZ) who eventually develop PHN (according to the diagnostic criteria of PHN, such as persistent pain for ≥3 months)
Key inclusion criteria (1 listed)
- The definite diagnoses were PHN (disease course ≤ 1 month), PHN (1 month < disease course < 2 months), and PHN (disease course > 3 months); Age equal to 50 years old; Not accompanied by other chronic pain diseases; Sign the informed consent form.
Key exclusion criteria (1 listed)
- There are underlying digestive system diseases such as irritable bowel syndrome and inflammatory bowel disease; There are obvious gastrointestinal discomfort symptoms such as diarrhea and abdominal distension; There is immunosuppression or autoimmune disease; Antibiotics, acid suppressants or drugs that interfere with the intestinal flora have been used within the past month; Have a history of mental illness or abuse of tobacco and alcohol (2 packs per day)
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 |
|---|---|---|
| Extract the serum and feces of the patients for standard screening of early biomarkersIn this study, blood and fecal samples from patients with herpes and herpes neuralgia were collected for genomic sequencing of the gut microbiota and metabolome analysis, etc. Based on the principle of diffusion tensor imaging, by measuring the anisotropic diffusion of white matter around the corpus callosum at the horizontal level of the lateral ventricle body, the lymphatic system clearance function is quantified | Other | HZ did not convert to the PHN group, Healthy control group, PHN Group |
| Meningeal lymphatic vessel imagingThe functional changes of the cerebral lymphatic system in patients with PHN were detected by meningeal lymphatic vessel imaging | Other | HZ did not convert to the PHN group, Healthy control group, PHN Group |
Primary outcome
HZ biomarkers
Time frame: 1 week
DNA was extracted from fecal samples for metagenomic sequencing. Based on the metagenomic sequencing results, we will select the important biomarkers that can distinguish the subgroups of HZ patients
1 secondary outcome
Lymphatic system function
Time frame: 1 week
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 26 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postherpetic Neuralgia ( PHN ) and Lymphatic System Disorder, run by Tongji Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HZ biomarkers (time frame: 1 week). 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 26 Jun 2025.