Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05515250 · ClinicalTrials.gov registry record · NA
Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain
A NA study, sponsored by St. Louis University.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT05515250 is a NA study that was terminated before completion, run by St. Louis University. The registered enrollment target is 1 participants.
The verdict
NCT05515250, a NA study, was terminated before completion, sponsored by St. Louis University.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
Chronic abdominal pain is extremely common in individuals with Cystic Fibrosis (CF). Therapy for chronic abdominal pain is very limited and generally consists of osmotic laxatives or drugs that are used to treat irritable bowel syndrome (IBS), most of which are off-label and not proven to be effective for CF patients. Abdominal pain negatively impacts the quality of life (QOL). With the development of novel therapies for CF, life expectancy has significantly increased. There is, therefore, a critical need to identify treatment pathways for chronic abdominal pain in children with CF. In humans, abdominal pain is modulated by the vagus nerve. Stimulation of the vagus nerve has been suggested to reduce visceral sensitivity and abdominal pain. IB-stim is the Percutaneous Electrical Nerve Field Stimulation (PENS) device. It is a non-invasive, outpatient therapy. PENFS has been shown to be efficacious in pediatric patients with abdominal pain. The FDA has cleared and classified this device as class II, suggesting minimal to moderate risk. There is increasing evidence of intestinal inflammation in patients with CF, which could help explain the GI symptoms and differentiate from IBS. Studies have reported increased inflammation in the intestines using fecal calprotectin. With the implementation of this study, investigators hypothesize that the IB -Stim device will reduce their overall GI inflammation and abdominal pain.
Interventions
- DEVICE Use of neurostimulation device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-03-29 |
| Est. Completion | 2023-07-25 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05515250
The ClinicalTrials.gov registry entry for NCT05515250 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Use of neurostimulation device is the first listed.
NCT05515250 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05515250 about?
NCT05515250 is a clinical study titled "Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain". Chronic abdominal pain is extremely common in individuals with Cystic Fibrosis (CF). Therapy for chronic abdominal pain is very limited and generally consists of osmotic laxatives or drugs that are used to treat irritable bowel syndrome (IBS), most of which are off-label and not proven to be effecti...
What is the current status of trial NCT05515250?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2023-03-29. Estimated completion is 2023-07-25.
What interventions are being tested in trial NCT05515250?
The interventions under investigation include: Use of neurostimulation device (DEVICE).
Who is sponsoring clinical trial NCT05515250?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.