Trial Outcomes & Findings for Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain (NCT NCT05515250)

Last Updated: 2024-08-09

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

baseline and 8 weeks

Results posted on

2024-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Open Label Only treatment Arm.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neuromodulation for Children With Cystic Fibrosis Experiencing Chronic Abdominal Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Open Label Intervention Arm n=1 Participants Use of neurostimulation device: 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.
Age, Categorical <=18 years	1 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	16 years n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	1 participants n=93 Participants

PRIMARY outcome

Timeframe: baseline and 8 weeks

Outcome measures

Outcome measures
Measure	Patient Open Label Intervention Arm n=1 Participants Use of neurostimulation device: 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.
IBS Severity Scoring System-Change Between Baseline and Week 8 is Reported. IBS Severity Scoring System at baseline	50 score on a scale
IBS Severity Scoring System-Change Between Baseline and Week 8 is Reported. IBS Severity Scoring System at week 8	25 score on a scale

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patient Open Label Intervention Arm n=1 Participants Use of neurostimulation device: 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.
CFQ-R and PedsQL Gastrointestinal Scale Score in Response to IB-Stim Treatment- Baseline and Week 8 Reported CFQ-R score at baseline	75 score on a scale
CFQ-R and PedsQL Gastrointestinal Scale Score in Response to IB-Stim Treatment- Baseline and Week 8 Reported PedsQL- Gastrointestinal Module score at baseline	78 score on a scale
CFQ-R and PedsQL Gastrointestinal Scale Score in Response to IB-Stim Treatment- Baseline and Week 8 Reported CFQ-R score at week 8	70 score on a scale
CFQ-R and PedsQL Gastrointestinal Scale Score in Response to IB-Stim Treatment- Baseline and Week 8 Reported PedsQL- Gastrointestinal Module score at week 8	73 score on a scale

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patient Open Label Intervention Arm n=1 Participants Use of neurostimulation device: 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.
Reduction in Stool Calprotectin Inflammatory Markers in Response to IB-Stim-change Between Two Time Point is Reported. Baseline	36 μg/mg
Reduction in Stool Calprotectin Inflammatory Markers in Response to IB-Stim-change Between Two Time Point is Reported. Week 4	30 μg/mg

Adverse Events

Open Label

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Purnima Modi

Saint Louis University

Phone: 3149772029

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place