Chronic PancreatitisNCT03707431
Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis
A study testing Web-based CBT and Pain Education in people with Chronic Pancreatitis and Acute Recurrent Pancreatitis, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Abdominal pain is common in children with chronic and acute recurring pancreatitis (CP, ARP), and as they continue into adulthood, the disease progresses with increased pain and greater exposure to opioids. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Chronic Pancreatitis, Acute Recurrent Pancreatitis
- What is being tested?
- Web-based CBT and Pain Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2019to 31 Jul 2024
- 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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with CP or ARP
- ages 10-19 years
- at least 4 acute pancreatitis flare-ups/attacks in past year, or at least 1 instance of moderate (4/10 pain) pancreatitis/abdominal pain in the past month
- access to the Internet on any web-enabled device
Who cannot join
- non-English speaking
- inability to read at the 5th grade level due to learning problem or developmental delay
- children with cystic fibrosis who have pancreatic insufficiency at the time of diagnosis
- patients with Shwachman-Bodian-Diamond Syndrome
- Acute Recurrent Pancreatitis (ARP) with no evidence of chronic or persistent pain
- anticipated surgery (TPIAT or other) during study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: A Randomized Trial of a Web-based Non-pharmacological Pain Intervention for Pediatric Chronic Pancreatitis
Abdominal pain is common in children with chronic and acute recurring pancreatitis (CP, ARP), and as they continue into adulthood, the disease progresses with increased pain and greater exposure to opioids. Despite the relevancy of early pain self-management for childhood pancreatitis, there have been no studies of non-pharmacological pain intervention in this population. The proposed project will evaluate a web-based cognitive behavioral pain management program delivered to a cohort of well-phenotyped children with CP/ARP and some community participants to reduce pain, pain-related disability and enhance HRQOL; it will also identify genetic risk factors and clinical and behavioral phenotypic factors associated with treatment response to enable precision medicine approaches.
Read the detailed description
Abdominal pain is present in 81% of children and adolescents with CP and ARP. Effective treatments that target pain in these children will lessen the risk of opioid exposure and continued pain and disability into adulthood. We plan to recruit a large multicenter sample of 260 children and adolescents (ages 10-19 years) with CP/ARP and their parents from INSPPIRE 2 (INSPPIRE:INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers and pancreatitis community groups (e.g. NPF) to evaluate the efficacy of WebMAP, a web-based cognitive behavioral pain management program (CBT). The study design is a two (group) x three (time point) randomized, controlled, double-blinded trial. Participants will be randomly assigned to receive online access to either pain education (WebED) or CBT (WebMAP) over an 8-10 week treatment period. The primary study outcome is abdominal pain symptoms measured at pre-treatment, immediately post-treatment, and at 6-month follow-up. Secondary outcomes include pain-related disability, health-related quality of life, depression and anxiety symptoms, and medication use. This project represents a significant advance in pain management for children with CP/ARP by evaluating the first ever nonpharmacologic pain intervention in these patients, which may guide future developments in the management of chronic pain associated with CP/ARP.
- Conditions
- Chronic Pancreatitis, Acute Recurrent Pancreatitis
- Being tested
- Web-based CBT, Pain Education
- Keywords
- Adolescent, Pancreatitis, Pain, Internet Intervention, Behavioral Intervention
- Medical subject headings
- Pancreatitis, Chronic, Pancreatitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based CBTBehavioural
Also called WebMAP
The eight child modules include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) deep breathing and relaxation, 4) implementing coping skills at school, 5) cognitive skills (e.g., reducing negative thoughts), 6) lifestyle interventions, 7) staying active (e.g., pleasant activity scheduling), 8) relapse prevention. The eight parent modules are: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) operant strategies I (using attention and praise to increase coping), 4) operant strategies II (using rewards to increase positive coping and reach school goals), 5) modeling, 6) lifestyle, 7) communication, 8) relapse prevention.
Pain EducationBehavioural
Also called WebED
The pain education website provides publicly available educational information about pancreatitis and abdominal pain. There is general information about pancreatitis from available web sources (e.g., National Pancreas Foundation) as well as information about chronic pain in childhood. The content does not include any instruction in the behavioral and cognitive skills taught within the WebMAP program.
| Study group | Role | What they receive |
|---|---|---|
| Web-based CBT (WebMAP) | Experimental | Receives access to WebMAP Receives: Behavioral: Web-based CBT |
| Pain Education (WebED) | Active comparator | Receives access to WebED Receives: Behavioral: Pain Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adolescent Abdominal Pain Severity
The Abdominal Pain Index (API) assesses characteristics of abdominal pain during the previous 2 weeks including the number of days with pain, number of pain episodes per day, typical pain episode duration, and typical pain intensity. An index is computed with higher scores indicating greater abdominal pain severity. A mean score is reported on a scale of 0 to 4, where higher values indicate more severe (worse) abdominal pain severity.
Measured: Baseline, 12 weeks, 6 months
Secondary outcomes (8)
Change in Pain-related Disability
The Child Activity Limitations Interview (CALI-9) is a daily diary validated to assess perceived difficulty in completing 9 daily activities as a measure of pain-related disability. Responses are rated on a 5-point scale (0-4) with higher scores indicating greater perceived difficulty with activities. Youth will provide ratings daily for 7 days on their online diaries at each assessment period. Mean total activity limitations across the reporting period is used in analyses, with higher scores indicating greater disability. The maximum possible total score is 36.
Measured: Baseline, 12 weeks, 6 months
Change in Health-related Quality of Life
The Pediatric Quality of Life Inventory (Peds-QL) assesses several domains of functioning, including physical, social, emotional, and academic functioning. The PedsQL is widely used as it demonstrates good reliability for both the parent and child self-report measures. Higher scores indicate fewer difficulties (better) health-related quality of life. Sub scales of physical and psychosocial health will be used in analyses. All scales range from 0 to 100.
Measured: Baseline, 12 weeks, 6 months
Change in Emotional Distress
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress Scales include an 8-item scale of anxiety (Pediatric v2.0 SF8a Anxiety) that assesses fear (e.g., fearfulness), anxious misery (e.g., worry) and hyperarousal (e.g., nervousness) and 8-item scale of depressive symptoms (Pediatric v2.0 SF8a Depressive Symptoms) that evaluates negative mood, view of self and social cognitions. Raw scores and T-scores are computed with T-scores above 60 indicating clinically elevated (worse) symptoms. The general population mean T-score is 50, with a standard deviation of 10. Anxiety T-scores range from 33.5-83.3, and depression T-scores range from 35.2-82.4.
Measured: Baseline, 12 weeks, 6 months
Change in Opioid Use
Over the counter and prescription (opioid and non-opioid) medication use in the preceding 7 days.
Measured: Baseline, 6 months
Change in Pain Self-efficacy
The Pain Self-Efficacy Scale is a 7-item measure that assesses the child's beliefs in carrying out activities when in pain. The scale has demonstrated good internal consistency, cross-informant reliability with parent report, and strong construct validity. Higher scores (score range 7-35) indicate higher self-efficacy.
Measured: Baseline, 12 weeks, 6 months
Change in Parent Impact of Pain
Parents will complete the Bath Adolescent Pain Questionnaire-Parent Impact Questionnaire (BAPQ-PIQ), a measure of the impact of parenting an adolescent with chronic pain. The BAPQ-PIQ is a 62-item questionnaire with 8 scales including: depressive symptoms, anxiety, pain catastrophizing, self-blame, partner relationship, social (leisure) functioning, parental behavior, and parental role strain. Items are rated on a 5-point frequency response scale (0 = never, 4 = always) with higher scores indicating more impaired (worse) functioning for all subscales. The BAPQ-PIQ has demonstrated good reliability and validity among parents of youth with chronic pain. Sub scales will be analyzed separately. For brevity given the number of time points and subscales, the depression (range: 0-36) and anxiety (range: 0-24) subscales are reported here.
Measured: Baseline, 12 weeks, 6 months
Change in Pain Interference
The PROMIS Pain Interference - v2.0 Pediatric Short Form 8a includes 8 items to assess consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The scale has been validated in pediatric patients with chronic pain. Raw scores and T-scores are computed with T-scores above 60 indicating clinically elevated (worse) symptoms. T-scores range from 34-78. The general population mean T-score is 50, with a standard deviation of 10.
Measured: Baseline, 12 weeks, 6 months
Change in Health Service Utilization
Parents will complete the Client Service Receipt Inventory-Pain version, a measure of service use, out-of-pocket expenses, and lost work time incurred by families for the evaluation or management of the child's chronic pain. Questions pertain to hospital admissions, outpatient services, community services (e.g., tutor, lawyer), medications, lost work time, paid help, and other costs. We will compute the following variables: total number of services used by category, number of lost parental work days, and number of out-of-pocket expenses; visits, medications, other treatments, and indirect costs as reported by the parent. For brevity, we will report the 2 primary variables used in analysis found to be related to child pain: the number of doctor outpatient service visits and number of emergency dept visits.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start25 Apr 2019
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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 (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized and double-blinded controlled trial of web-based CBT (WebMAP) vs pain education (WebED).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, University of Virginia, Washington University School of Medicine, M.D. Anderson Cancer Center, The University of Texas Health Science Center, Houston, Children's Hospital Medical Center, Cincinnati, Children's Hospital Los Angeles, Children's Hospital of Philadelphia, University of Toronto, McGill University Health Centre/Research Institute of the McGill University Health Centre, Medical College of Wisconsin, Massachusetts General Hospital, University of Minnesota, Ohio State University, University of Pittsburgh, University of California, San Francisco, University of Utah, Indiana University, Sydney Children's Hospitals Network, Cedars-Sinai Medical Center, Stanford University, Ariel Precision Medicine, University of Texas Southwestern Medical Center
- Responsible party
- Principal investigator, Tonya Palermo, Seattle Children's Hospital
- Investigators
- Tonya Palermo, PhD, Principal investigator, Seattle Children's HospitalAliye Uc, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707431
- Sponsor's protocol ID
- 1R01DK118752-01
- Status last verified
- Mar 2026
- First submitted
- 2 Oct 2018
- Last updated
- 9 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Palermo TM, Murray C, Aalfs H, Abu-El-Haija M, Barth B, Bellin MD, Ellery K, Fishman DS, Gariepy CE, Giefer MJ, Goday P, Gonska T, Heyman MB, Husain SZ, Lin TK, Liu QY, Mascarenhas MR, Maqbool A, McFerron B, Morinville VD, Nathan JD, Ooi CY, Perito ER, Pohl JF, Schwarzenberg SJ, Sellers ZM, Serrano J, Shah U, Troendle D, Zheng Y, Yuan Y, Lowe M, Uc A; Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer. Web-based cognitive-behavioral intervention for pain in pediatric acute recurrent and chronic pancreatitis: Protocol of a multicenter randomized controlled trial from the study of chronic pancreatitis, diabetes and pancreatic cancer (CPDPC). Contemp Clin Trials. 2020 Jan;88:105898. doi: 10.1016/j.cct.2019.105898. Epub 2019 Nov 19.
PubMed 31756383Palermo TM, Li R, Zhou C, Aalfs H, Cress G, Lowe M, Abu-El-Haija M, Chugh A, Downs EM, Fishman DS, Freeman AJ, Giefer MJ, Gonska TY, Husain SZ, Lindblad D, Liu QY, Maqbool A, Mark JA, McFerron BA, Mehta MS, Noel RA, Perito ER, Wang F, Yuan Y, Zheng Y, Uc A; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). Internet-delivered Cognitive-Behavioral Intervention for Pain in Pediatric Acute Recurrent and Chronic Pancreatitis: A Multicenter Randomized Controlled Trial. Pancreas. 2026 Feb 1;55(2):e137-e146. doi: 10.1097/MPA.0000000000002558.
PubMed 41385443
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a Web-based Non-pharmacological Pain Intervention for Pediatric Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT03707431
- Acronym / sponsor ID
- 1R01DK118752-01
- Conditions
- Chronic Pancreatitis, Acute Recurrent Pancreatitis
- Keywords
- Adolescent, Pancreatitis, Pain, Internet Intervention, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- University of Iowa, University of Virginia, Washington University School of Medicine, M.D. Anderson Cancer Center, The University of Texas Health Science Center, Houston, Children's Hospital Medical Center, Cincinnati, Children's Hospital Los Angeles, Children's Hospital of Philadelphia, University of Toronto, McGill University Health Centre/Research Institute of the McGill University Health Centre, Medical College of Wisconsin, Massachusetts General Hospital, University of Minnesota, Ohio State University, University of Pittsburgh, University of California, San Francisco, University of Utah, Indiana University, Sydney Children's Hospitals Network, Cedars-Sinai Medical Center, Stanford University, Ariel Precision Medicine, University of Texas Southwestern Medical Center
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Posted 9 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Abdominal pain is common in children with chronic and acute recurring pancreatitis (CP, ARP), and as they continue into adulthood, the disease progresses with increased pain and greater exposure to opioids. Despite the relevancy of early pain self-management for childhood pancreatitis, there have been no studies of non-pharmacological pain intervention in this population. The proposed project will evaluate a web-based cognitive behavioral pain management program delivered to a cohort of well-phenotyped children with CP/ARP and some community participants to reduce pain, pain-related disability and enhance HRQOL; it will also identify genetic risk factors and clinical and behavioral phenotypic factors associated with treatment response to enable precision medicine approaches.
Detailed description
Abdominal pain is present in 81% of children and adolescents with CP and ARP. Effective treatments that target pain in these children will lessen the risk of opioid exposure and continued pain and disability into adulthood. We plan to recruit a large multicenter sample of 260 children and adolescents (ages 10-19 years) with CP/ARP and their parents from INSPPIRE 2 (INSPPIRE:INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers and pancreatitis community groups (e.g. NPF) to evaluate the efficacy of WebMAP, a web-based cognitive behavioral pain management program (CBT). The study design is a two (group) x three (time point) randomized, controlled, double-blinded trial. Participants will be randomly assigned to receive online access to either pain education (WebED) or CBT (WebMAP) over an 8-10 week treatment period. The primary study outcome is abdominal pain symptoms measured at pre-treatment, immediately post-treatment, and at 6-month follow-up. Secondary outcomes include pain-related disability, health-related quality of life, depression and anxiety symptoms, and medication use. This project represents a significant advance in pain management for children with CP/ARP by evaluating the first ever nonpharmacologic pain intervention in these patients, which may guide future developments in the management of chronic pain associated with CP/ARP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized and double-blinded controlled trial of web-based CBT (WebMAP) vs pain education (WebED).
| Arm | Type | Receives |
|---|---|---|
| Web-based CBT (WebMAP) | Experimental | Behavioral: Web-based CBTReceives access to WebMAP |
| Pain Education (WebED) | Active comparator | Behavioral: Pain EducationReceives access to WebED |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed with CP or ARP
- ages 10-19 years
- at least 4 acute pancreatitis flare-ups/attacks in past year, or at least 1 instance of moderate (4/10 pain) pancreatitis/abdominal pain in the past month
- access to the Internet on any web-enabled device
Key exclusion criteria (6 listed)
- non-English speaking
- inability to read at the 5th grade level due to learning problem or developmental delay
- children with cystic fibrosis who have pancreatic insufficiency at the time of diagnosis
- patients with Shwachman-Bodian-Diamond Syndrome
- Acute Recurrent Pancreatitis (ARP) with no evidence of chronic or persistent pain
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 |
|---|---|---|
| Web-based CBTAlso: WebMAPThe eight child modules include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) deep breathing and relaxation, 4) implementing coping skills at school, 5) cognitive skills (e.g., reducing negative thoughts), 6) lifestyle interventions, 7) staying active (e.g., pleasant activity scheduling), 8) relapse prevention. The eight parent modules are: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) operant strategies I (using attention and praise to increase coping), 4) operant strategies II (using rewards to increase positive coping and reach school goals), 5) modeling, 6) lifestyle, 7) communication, 8) relapse prevention. | Behavioural | Web-based CBT (WebMAP) |
| Pain EducationAlso: WebEDThe pain education website provides publicly available educational information about pancreatitis and abdominal pain. There is general information about pancreatitis from available web sources (e.g., National Pancreas Foundation) as well as information about chronic pain in childhood. The content does not include any instruction in the behavioral and cognitive skills taught within the WebMAP program. | Behavioural | Pain Education (WebED) |
Primary outcome
Change in Adolescent Abdominal Pain Severity
Time frame: Baseline, 12 weeks, 6 months
The Abdominal Pain Index (API) assesses characteristics of abdominal pain during the previous 2 weeks including the number of days with pain, number of pain episodes per day, typical pain episode duration, and typical pain intensity. An index is computed with higher scores indicating greater abdominal pain severity. A mean score is reported on a scale of 0 to 4, where higher values indicate more severe (worse) abdominal pain severity.
8 secondary outcomes
Change in Pain-related Disability
Time frame: Baseline, 12 weeks, 6 months
Change in Health-related Quality of Life
Time frame: Baseline, 12 weeks, 6 months
Change in Emotional Distress
Time frame: Baseline, 12 weeks, 6 months
Change in Opioid Use
Time frame: Baseline, 6 months
Change in Pain Self-efficacy
Time frame: Baseline, 12 weeks, 6 months
Change in Parent Impact of Pain
Time frame: Baseline, 12 weeks, 6 months
Change in Pain Interference
Time frame: Baseline, 12 weeks, 6 months
Change in Health Service Utilization
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31756383Palermo TM, Murray C, Aalfs H, Abu-El-Haija M, Barth B, Bellin MD, Ellery K, Fishman DS, Gariepy CE, Giefer MJ, Goday P, Gonska T, Heyman MB, Husain SZ, Lin TK, Liu QY, Mascarenhas MR, Maqbool A, McFerron B, Morinville VD, Nathan JD, Ooi CY, Perito ER, Pohl JF, Schwarzenberg SJ, Sellers ZM, Serrano J, Shah U, Troendle D, Zheng Y, Yuan Y, Lowe M, Uc A; Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer. Web-based cognitive-behavioral intervention for pain in pediatric acute recurrent and chronic pancreatitis: Protocol of a multicenter randomized controlled trial from the study of chronic pancreatitis, diabetes and pancreatic cancer (CPDPC). Contemp Clin Trials. 2020 Jan;88:105898. doi: 10.1016/j.cct.2019.105898. Epub 2019 Nov 19.
- Derived from this study: PubMed 41385443Palermo TM, Li R, Zhou C, Aalfs H, Cress G, Lowe M, Abu-El-Haija M, Chugh A, Downs EM, Fishman DS, Freeman AJ, Giefer MJ, Gonska TY, Husain SZ, Lindblad D, Liu QY, Maqbool A, Mark JA, McFerron BA, Mehta MS, Noel RA, Perito ER, Wang F, Yuan Y, Zheng Y, Uc A; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). Internet-delivered Cognitive-Behavioral Intervention for Pain in Pediatric Acute Recurrent and Chronic Pancreatitis: A Multicenter Randomized Controlled Trial. Pancreas. 2026 Feb 1;55(2):e137-e146. doi: 10.1097/MPA.0000000000002558.
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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.
Tonya Palermo, PhD principal investigator
Seattle Children's Hospital
Aliye Uc, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based CBT and Pain Education in people with Chronic Pancreatitis and Acute Recurrent Pancreatitis, run by Seattle Children's Hospital 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 9 Apr 2026. 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 Apr 2026). 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?
Change in Adolescent Abdominal Pain Severity (time frame: Baseline, 12 weeks, 6 months). 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 NCT03707431, which also lists 2 linked publications.
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 Apr 2026.