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NCT05550194 · ClinicalTrials.gov registry record · Phase 4
VZV in the Enteric Nervous System: Pathogenesis and Consequences
A Phase 4 study of Achalasia, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05550194: Recruiting Phase 4 study of Achalasia, sponsored by Vanderbilt University Medical Center.
NCT05550194 is a Phase 4 study of Achalasia that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 40 participants, below the 136-participant average among 7 other Achalasia trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05550194, a Phase 4 study of Achalasia, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Varicella zoster virus (VZV) is the cause of chickenpox and shingles, but it also infects, becomes latent, and reactivates in nerve cells of the bowel to cause a gastrointestinal disorder ("enteric shingles"). The Investigators recently found that a chronic active VZV infection, a form of enteric shingles, is associated with achalasia, a severe disease in which the passage of food from esophagus to stomach is impaired. We now propose to eradicate VZV to determine whether its association with achalasia is causal, to identify the genetic basis behind VZV reactivation in the esophagus, and the relationship of mast cells to enteric shingles and abdominal pain.
Primary Outcome
Response will be measured by the Eckardt score. The Eckardt score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with a score of 0 indicating the absence of symptoms, 1 indicating occasional symptoms, 2 indicating daily symptoms, and 3 indicating symptoms at each meal) and weight loss (with 0 indicating no weight loss, 1 indicating a loss of \<5 kg, 2 indicating a loss of 5 to 10 kg, and 3 indicating a loss of \>10 kg).
Conditions Studied
Interventions
- BIOLOGICAL Shingrix
- DRUG ValACYclovir 1000 MG
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-03-27 |
| Est. Completion | 2026-08 |
| Phase | Phase 4 |
What NCT05550194 shows while recruiting
NCT05550194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 136-participant average among 7 other Achalasia trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Achalasia appearing as the primary indexed condition, and to 2 interventions - of which Shingrix is the first listed.
NCT05550194 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT05550194 about?
NCT05550194 is a clinical study titled "VZV in the Enteric Nervous System: Pathogenesis and Consequences". Varicella zoster virus (VZV) is the cause of chickenpox and shingles, but it also infects, becomes latent, and reactivates in nerve cells of the bowel to cause a gastrointestinal disorder ("enteric shingles"). The Investigators recently found that a chronic active VZV infection, a form of enteric sh...
What is the current status of trial NCT05550194?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2023-03-27. Estimated completion is 2026-08.
What conditions does trial NCT05550194 study?
This clinical trial studies the following conditions: Achalasia.
What interventions are being tested in trial NCT05550194?
The interventions under investigation include: Shingrix (BIOLOGICAL), ValACYclovir 1000 MG (DRUG).
Who is sponsoring clinical trial NCT05550194?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05550194 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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