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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: Clinical Trial NA study, sponsored by St. Louis University.
NCT05515250 is a NA study that was terminated before completion, run by St. Louis University. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
IBS-SSS is a tool for assessing IBS. Please refer to the following for further understanding of this tool. It records Part 1- Severity Score( 0-500 where 0 is no symptom and 500 is the severe symptoms) and Part 2 ' Other IBS Data' under which includes bowel habits, consistency of bowel movements, red flag symptoms, site of pain and absence from work due to IBS. We cannot use part 2 because it does not have assigned scoring system and as such not suitable for patients with CF due to know genetic
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 |
Why NCT05515250 stopped before completion
NCT05515250 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Use of neurostimulation device is the first listed.
NCT05515250 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT05515250's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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