Cystic FibrosisNCT05515250
Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain
A study testing Use of neurostimulation device in people with Cystic Fibrosis and Irritable Bowel Syndrome, run by St. Louis University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Cystic Fibrosis, Irritable Bowel Syndrome, Chronic Pain
- What is being tested?
- Use of neurostimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- English-speaking and willing to consent and follow the study protocol
- Children with CF aged 11-17 years at the time of enrollment. All races, ethnic groups and both sexes will be included. Patient turning 18 years after enrollment in the study will continue in study and complete remaining study visits.
- Minimum of 2 days of abdominal pain/week for a duration of two months or greater prior to starting the study
- Average weekly abdominal pain score of at least 3 for the previous 2 weeks prior to entering the study (on a 0-10-point rating scale).
- Abdominal pain is not explained by any major organic etiology and comprehensive work up failed to identify any single cause for patients' symptoms
Who cannot join
- Patients age of 18 years and over, or less than 11 years at the time of enrollment
- Patients who cannot provide informed consent or do not speak English
- Patients with abdominal pain that can be explained clinically by other GI diagnoses other than CF per study doctor's judgement
- History of cranial nerve or major abdominal surgeries in last 6 months
- Patients with underlying neurologic conditions, including history of ongoing seizures or traumatic brain injury within last 6 months
- Patients with dermatologic conditions affecting the ears (i.e. psoriasis), or with cuts or abrasions to the external ear that would interfere with electrode placement
Show all 11Show fewer
- Patients with hemophilia or other bleeding disorders
- Patients with any implanted electromagnetic device
- Inability to comply with study protocol and follow up, per study doctor's judgement.
- Pregnant females, females who are breastfeeding or who believe they may wish to become pregnant during the course of the study
- Males and females of reproductive potential who are unwilling to use effective measures (chosen in consultation with their health care provider) to avoid becoming pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromodulation With Percutaneous Electrical Nerve Field Stimulation 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 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.
Read more
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.
- Conditions
- Cystic Fibrosis, Irritable Bowel Syndrome, Chronic Pain
- Being tested
- Use of neurostimulation device
- Medical subject headings
- Cystic Fibrosis, Irritable Bowel Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of neurostimulation deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient open label intervention arm | Other | Not described Receives: Device: Use of neurostimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS Severity Scoring System-Change Between Baseline and Week 8 is Reported.
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 mutation in CF causing many similar symptoms of IBS. It has nine stem q: five questions ( in Part 1) have scores of between 0 and 100 for each question, based on visual analogue scales, each minimum of 0 to max of 100.We report combined sub score at baseline and week 8. A score below 75 is seen in healthy people or in remission of IBS, 75-175 indicates mild disease, 175-300 moderate disease and over 300 severe. The score is interpreted as an absolute change from the baseline and at week 8.
Measured: baseline and 8 weeks
CFQ-R and PedsQL Gastrointestinal Scale Score in Response to IB-Stim Treatment- Baseline and Week 8 Reported
Name of categories/domains CFQ-R:
9 Quality of life domains: Physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions.
3 symptom scales: Weight, respiratory, and digestion. Scaling of items: 5 distinct 4-point Likert scales (e.g., always/often/ sometime/never)
Scoring: Range from 0 to 100, with higher scores indicating better health.
PedsQL consists of 74 items comprising 14 dimensions Likert scale from 0 to 4.Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0.Total Score: Sum of all the items over the number of items answered on all the Scales. PedsQL scoring interpretation: In general, the higher scores indicating better health for this measure.
Baseline and week 8 reported
Measured: baseline and 8 weeks
Reduction in Stool Calprotectin Inflammatory Markers in Response to IB-Stim-change Between Two Time Point is Reported.
Investigators hypothesize that at 4 weeks following PENFS treatment initiation, there will be a reduction in stool calprotectin to baseline. The higher the value, worse the disease. The value above 200 ug/mg is considered to be suggestive of significant inflammation in the gut.
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start29 Mar 2023
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Why it stopped: inadequate enrollment. Found only one participant over 1 year as opposed to anticipated over 15 patients. Inadequate research funding and staff support also added to this decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Principal investigator, Dhiren Patel, MD, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515250
- Sponsor's protocol ID
- 31972
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2022
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Unsure about the number of participants and their willingness to allow us to share the data.
Publications
Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402. doi: 10.1046/j.1365-2036.1997.142318000.x.
PubMed 9146781
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain
- ClinicalTrials.gov ID
- NCT05515250
- Acronym / sponsor ID
- 31972
- Conditions
- Cystic Fibrosis, Irritable Bowel Syndrome, Chronic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inadequate enrollment. Found only one participant over 1 year as opposed to anticipated over 15 patients. Inadequate research funding and staff support also added to this decision.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 25 Aug 2022 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient open label intervention arm | Other | Device: Use of neurostimulation device |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- English-speaking and willing to consent and follow the study protocol
- Children with CF aged 11-17 years at the time of enrollment. All races, ethnic groups and both sexes will be included. Patient turning 18 years after enrollment in the study will continue in study and complete remaining study visits.
- Minimum of 2 days of abdominal pain/week for a duration of two months or greater prior to starting the study
- Average weekly abdominal pain score of at least 3 for the previous 2 weeks prior to entering the study (on a 0-10-point rating scale).
- Abdominal pain is not explained by any major organic etiology and comprehensive work up failed to identify any single cause for patients' symptoms
Key exclusion criteria (11 listed)
- Patients age of 18 years and over, or less than 11 years at the time of enrollment
- Patients who cannot provide informed consent or do not speak English
- Patients with abdominal pain that can be explained clinically by other GI diagnoses other than CF per study doctor's judgement
- History of cranial nerve or major abdominal surgeries in last 6 months
- Patients with underlying neurologic conditions, including history of ongoing seizures or traumatic brain injury within last 6 months
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 |
|---|---|---|
| Use of neurostimulation deviceIn 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. | Device | Patient open label intervention arm |
Primary outcome
IBS Severity Scoring System-Change Between Baseline and Week 8 is Reported.
Time frame: baseline and 8 weeks
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 mutation in CF causing many similar symptoms of IBS. It has nine stem q: five questions ( in Part 1) have scores of between 0 and 100 for each question, based on visual analogue scales, each minimum of 0 to max of 100.We report combined sub score at baseline and week 8. A score below 75 is seen in healthy people or in remission of IBS, 75-175 indicates mild disease, 175-300 moderate disease and over 300 severe. The score is interpreted as an absolute change from the baseline and at week 8.
CFQ-R and PedsQL Gastrointestinal Scale Score in Response to IB-Stim Treatment- Baseline and Week 8 Reported
Time frame: baseline and 8 weeks
Name of categories/domains CFQ-R: 9 Quality of life domains: Physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions. 3 symptom scales: Weight, respiratory, and digestion. Scaling of items: 5 distinct 4-point Likert scales (e.g., always/often/ sometime/never) Scoring: Range from 0 to 100, with higher scores indicating better health. PedsQL consists of 74 items comprising 14 dimensions Likert scale from 0 to 4.Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0.Total Score: Sum of all the items over the number of items answered on all the Scales. PedsQL scoring interpretation: In general, the higher scores indicating better health for this measure. Baseline and week 8 reported
Reduction in Stool Calprotectin Inflammatory Markers in Response to IB-Stim-change Between Two Time Point is Reported.
Time frame: Baseline and week 4
Investigators hypothesize that at 4 weeks following PENFS treatment initiation, there will be a reduction in stool calprotectin to baseline. The higher the value, worse the disease. The value above 200 ug/mg is considered to be suggestive of significant inflammation in the gut.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9146781Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402. doi: 10.1046/j.1365-2036.1997.142318000.x.
- Individual participant dataSharing planned: Undecided. Unsure about the number of participants and their willingness to allow us to share the data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of neurostimulation device in people with Cystic Fibrosis and Irritable Bowel Syndrome, run by St. Louis University at 1 site in United States.
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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
IBS Severity Scoring System-Change Between Baseline and Week 8 is Reported. (time frame: baseline and 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05515250, which also lists 1 linked publication.
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 9 Aug 2024.