Disorders of Gut-brain InteractionNCT07435610
Acupuncture Therapy for Pediatric Disorders of Gut-Brain Interaction
A study testing Active Therapeutic acupuncture intervention in people with Disorders of Gut-brain Interaction, run by Children's Hospital of Orange County at 1 site in United States.
Trial summary
Disorders of Gut-Brain Interactions (DGBIs) significantly impact children globally, leading to reduced quality of life and increased healthcare utilization. Despite their prevalence, effective treatments for pediatric DGBIs remain limited. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Disorders of Gut-brain Interaction
- What is being tested?
- Active Therapeutic acupuncture intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8-17 years
- Diagnosis of FAP-NOS, IBS, or abdominal migraine (Rome IV criteria; partial criteria permitted)
- Stable use (≥8 weeks) of antidepressant and/or ADHD medications, if applicable
- Functional constipation, if present, controlled on maintenance therapy
- Ability of participant and caregiver to comply with study procedures
Who cannot join
- Prior treatment with IB-Stim, acupuncture, or other auricular/percutaneous nerve field stimulation modalities.
- Diagnosis of functional dyspepsia.
- Untreated constipation at screening.
- Use of ketamine, opioids, antibiotics, or probiotics within 2 weeks prior to treatment initiation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CHOC Center for Children's Health Building: Joe C. Wen & Family Center for Advanced Care (CAC)
Irvine, California, 92612
Heidi Joyce, BS, 714-509-8765, heidi.joyce@choc.org
Ashish Chogle, MD
About this study
Official title: A Randomized, Participant- and Assessor-Blinded, Sham-Controlled Trial Investigating Acupuncture for Disorders of Gut-Brain Interaction in Children (P-GAP)
Disorders of Gut-Brain Interactions (DGBIs) significantly impact children globally, leading to reduced quality of life and increased healthcare utilization. Despite their prevalence, effective treatments for pediatric DGBIs remain limited. Acupuncture, though commonly used in clinical practice and supported by adult data, lacks robust empirical evidence in pediatric populations. This study addresses this critical gap.
The primary objective is to assess the efficacy of acupuncture in reducing symptom severity in pediatric patients with DGBIs. Key secondary objectives include evaluating improvements in quality of life, functional disability, and mental health outcomes.
Read more
This is a parallel-group, randomized, placebo sham-controlled, participant-blind clinical trial. The study is being conducted in an outpatient pediatric referral center. A total of 96 participants, aged 8-17 years, meeting eligibility criteria for DGBIs will be enrolled. Participants must be medically stable and meet protocol-defined inclusion/exclusion criteria.
Participants will be randomly assigned to receive either acupuncture or sham acupuncture, alongside standard care. Treatments will occur over a predefined protocol period. Data will be collected at baseline, during treatment, and at specified post-treatment intervals. The primary outcomes will evaluate changes in pain intensity and frequency. Secondary outcomes will include assessments of pain resolution, quality of life, functional disability, and mental health. Statistical analyses will employ rigorous methodologies to ensure reliability and validity of findings.
- Conditions
- Disorders of Gut-brain Interaction
- Being tested
- Active Therapeutic acupuncture intervention, Sham therapeutic acupuncture treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Therapeutic acupuncture interventionOther
P-GAP is a prospective, randomized, placebo (sham)-controlled, participant- and assessor-blinded superiority trial. The trial evaluates the efficacy and safety of acupuncture in pediatric patients with DGBIs. Participants will be randomly assigned to receive either standardized acupuncture or sham acupuncture over an 8-week treatment period, followed by a post-treatment evaluation. The study includes a screening and run-in phase, a treatment phase, and a follow-up phase.
Sham therapeutic acupuncture treatmentOther
Control/sham group participants will receive sham acupuncture using sterile, single-use Park Sham Acupuncture Devices at identical scalp points. This mimics the sensation of acupuncture without needle insertion to maintain participant blinding.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | The active treatment group will receive standardized acupuncture based on a protocol for functional abdominal pain, using seven acupuncture points: ST36 (Zusanli), LV3 (Taichong), REN12 (Zhongwan), PC6 (Neiguan), SP4 (Gongsun), EX-HN (Sishencong), and DU24 (Shenting) using sterile, single-use Seirin needles. Sessions will occur once weekly for eight weeks, each lasting 40 minutes. Receives: Other: Active Therapeutic acupuncture intervention |
| Control/Sham | Sham comparator | The control group will receive Park Sham Acupuncture Devices at the same scalp points, designed to mimic the sensation of acupuncture without actual needle insertion. Both groups will continue receiving standard care throughout the study. Receives: Other: Sham therapeutic acupuncture treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate Pain Relief:
The primary outcome is the proportion of participants achieving adequate pain relief, defined as a ≥30% reduction from baseline in mean abdominal pain severity on the 11-point Numerical Rating Scale from baseline to follow-up at Weeks 12-14. This threshold reflects the Rome Foundation's definition of clinically meaningful improvement in pediatric functional abdominal pain disorders.
Measured: Baseline to Weeks 12-14
Secondary outcomes (6)
Pain Severity
Pain intensity will be measured using the 11-point Numerical Rating Scale (NRS; 0 = no pain, 10 = worst pain). Participants will record daily NRS scores during the baseline run-in period and at Weeks 4-5, 8-9, and 12-14. For each timepoint, pain severity will be defined as the means of daily scores recorded over the final 7 days. Change in mean pain severity will be evaluated from baseline to follow-up at Weeks 12-14.
Measured: Baseline to Week 12-14
Pain Frequency
Participants will record the number of pain episodes using daily symptom diaries. Outcomes will be defined as the mean number of episodes recorded over the final 7 days of each assessment period, including baseline and follow-up assessment at Week 12-14.
Measured: Baseline to Week 12-14.
Rome IV diagnostic classification
DGBI status will be assessed using Rome IV questionnaires at baseline, Week 4, Week 8, and Week 12-14. Changes in whether participants meet Rome IV criteria for specific DGBIs will be evaluated over time.
Measured: Baseline to Week 12-14
Health-Related Quality of Life
Health-related quality of life will be measured using the Pediatric Quality of Life Inventory™ (PedsQL™) Gastrointestinal Symptoms Module at baseline, Week 4, Week 8, and Week 12-14
Measured: Baseline to Week 12-14
Psychological Well-Being
Anxiety and depressive symptoms will be measured using the PROMIS Pediatric Anxiety and Depression Scales at baseline, Week 4, Week 8, and Week 12-14.
Measured: Baseline to Week 12-14.
Safety and Serious Adverse Events (SAEs)
Safety will be assessed based on the incidence, severity, and relatedness of adverse events, classified using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Serious adverse events will be reviewed and reported in accordance with institutional requirements.
Measured: Baseline to Week 12-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start8 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorders of Gut-brain InteractionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Orange County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashish Chogle, Children's Hospital of Orange County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435610
- Sponsor's protocol ID
- 250226
- Status last verified
- Jun 2026
- First submitted
- 14 Aug 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the final publication will be made available upon reasonable request, where legally and ethically permissible, after completion of the study and publication of the primary results. Requests will be reviewed by the study investigators and may require approval of a proposal and execution of a data use agreement.
Publications
Chogle A, Gordon M, McCarty R, Joyce H, Janchoi J, Khoo J, Espinoza K, Velazquez G, Tran T, Taube A, Mokhtari P. A randomised, participant- and assessor-blinded, sham-controlled trial investigating acupuncture for disorders of gut-brain interaction in children (P-GAP). BMJ Open. 2026 Sep 22;16(9):e121725. doi: 10.1136/bmjopen-2026-121725.
PubMed 42772880
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Participant- and Assessor-Blinded, Sham-Controlled Trial Investigating Acupuncture for Disorders of Gut-Brain Interaction in Children (P-GAP)
- ClinicalTrials.gov ID
- NCT07435610
- Acronym / sponsor ID
- 250226
- Conditions
- Disorders of Gut-brain Interaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Children's Hospital of Orange CountyUniversity, hospital or other
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Disorders of Gut-Brain Interactions (DGBIs) significantly impact children globally, leading to reduced quality of life and increased healthcare utilization. Despite their prevalence, effective treatments for pediatric DGBIs remain limited. Acupuncture, though commonly used in clinical practice and supported by adult data, lacks robust empirical evidence in pediatric populations. This study addresses this critical gap.
The primary objective is to assess the efficacy of acupuncture in reducing symptom severity in pediatric patients with DGBIs. Key secondary objectives include evaluating improvements in quality of life, functional disability, and mental health outcomes.
This is a parallel-group, randomized, placebo sham-controlled, participant-blind clinical trial. The study is being conducted in an outpatient pediatric referral center. A total of 96 participants, aged 8-17 years, meeting eligibility criteria for DGBIs will be enrolled. Participants must be medically stable and meet protocol-defined inclusion/exclusion criteria.
Participants will be randomly assigned to receive either acupuncture or sham acupuncture, alongside standard care. Treatments will occur over a predefined protocol period. Data will be collected at baseline, during treatment, and at specified post-treatment intervals. The primary outcomes will evaluate changes in pain intensity and frequency. Secondary outcomes will include assessments of pain resolution, quality of life, functional disability, and mental health. Statistical analyses will employ rigorous methodologies to ensure reliability and validity of findings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Other: Active Therapeutic acupuncture interventionThe active treatment group will receive standardized acupuncture based on a protocol for functional abdominal pain, using seven acupuncture points: ST36 (Zusanli), LV3 (Taichong), REN12 (Zhongwan), PC6 (Neiguan), SP4 (Gongsun), EX-HN (Sishencong), and DU24 (Shenting) using sterile, single-use Seirin needles. Sessions will occur once weekly for eight weeks, each lasting 40 minutes. |
| Control/Sham | Sham comparator | Other: Sham therapeutic acupuncture treatmentThe control group will receive Park Sham Acupuncture Devices at the same scalp points, designed to mimic the sensation of acupuncture without actual needle insertion. Both groups will continue receiving standard care throughout the study. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 8-17 years
- Diagnosis of FAP-NOS, IBS, or abdominal migraine (Rome IV criteria; partial criteria permitted)
- Stable use (≥8 weeks) of antidepressant and/or ADHD medications, if applicable
- Functional constipation, if present, controlled on maintenance therapy
- Ability of participant and caregiver to comply with study procedures
Key exclusion criteria (4 listed)
- Prior treatment with IB-Stim, acupuncture, or other auricular/percutaneous nerve field stimulation modalities.
- Diagnosis of functional dyspepsia.
- Untreated constipation at screening.
- Use of ketamine, opioids, antibiotics, or probiotics within 2 weeks prior to treatment initiation
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 |
|---|---|---|
| Active Therapeutic acupuncture interventionP-GAP is a prospective, randomized, placebo (sham)-controlled, participant- and assessor-blinded superiority trial. The trial evaluates the efficacy and safety of acupuncture in pediatric patients with DGBIs. Participants will be randomly assigned to receive either standardized acupuncture or sham acupuncture over an 8-week treatment period, followed by a post-treatment evaluation. The study includes a screening and run-in phase, a treatment phase, and a follow-up phase. | Other | Active |
| Sham therapeutic acupuncture treatmentControl/sham group participants will receive sham acupuncture using sterile, single-use Park Sham Acupuncture Devices at identical scalp points. This mimics the sensation of acupuncture without needle insertion to maintain participant blinding. | Other | Control/Sham |
Primary outcome
Adequate Pain Relief:
Time frame: Baseline to Weeks 12-14
The primary outcome is the proportion of participants achieving adequate pain relief, defined as a ≥30% reduction from baseline in mean abdominal pain severity on the 11-point Numerical Rating Scale from baseline to follow-up at Weeks 12-14. This threshold reflects the Rome Foundation's definition of clinically meaningful improvement in pediatric functional abdominal pain disorders.
6 secondary outcomes
Pain Severity
Time frame: Baseline to Week 12-14
Pain Frequency
Time frame: Baseline to Week 12-14.
Rome IV diagnostic classification
Time frame: Baseline to Week 12-14
Health-Related Quality of Life
Time frame: Baseline to Week 12-14
Psychological Well-Being
Time frame: Baseline to Week 12-14.
Safety and Serious Adverse Events (SAEs)
Time frame: Baseline to Week 12-14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 42772880Chogle A, Gordon M, McCarty R, Joyce H, Janchoi J, Khoo J, Espinoza K, Velazquez G, Tran T, Taube A, Mokhtari P. A randomised, participant- and assessor-blinded, sham-controlled trial investigating acupuncture for disorders of gut-brain interaction in children (P-GAP). BMJ Open. 2026 Sep 22;16(9):e121725. doi: 10.1136/bmjopen-2026-121725.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the final publication will be made available upon reasonable request, where legally and ethically permissible, after completion of the study and publication of the primary results. Requests will be reviewed by the study investigators and may require approval of a proposal and execution of a data use agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Therapeutic acupuncture intervention in people with Disorders of Gut-brain Interaction, run by Children's Hospital of Orange County 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 4 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: looking for participants now, as of the sponsor's last update on 5 Jun 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pari Mokhtari ((714)509-4264, pmokhtari@choc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate Pain Relief: (time frame: Baseline to Weeks 12-14). 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 NCT07435610, 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 5 Jun 2026.