Gastrointestinal Motility Disorders in ChildrenSMART-GUTNCT07519915
Improvement of Understanding of Pediatric Sacral Neuromodulation: Therapeutic Strategies and Outcome Variables
A study testing SNM/MRI/EMG in people with Gastrointestinal Motility Disorders in Children and Hirschsprung Disease, run by Friedrich-Alexander-Universität Erlangen-Nürnberg at 1 site in Germany.
Trial summary
The goal of this study is to learn about the effects of sacral neuromodulation in pediatric patients with gastrointestinal motility disorders. By combining advanced neuroimaging, patient-specific biophysical modeling, electrophysiological characterization, and clinical translation, the SMART-GUT project establishes a… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Gastrointestinal Motility Disorders in Children, Hirschsprung Disease, Constipation - Functional
- What is being tested?
- SNM/MRI/EMG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2018to 31 Dec 2029
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- informed consent of patient and care taker
- gastrointestinal motility disorder, disregarding underlying diseases
- exclusion of mechanical obstructions in the gastrointestinal passage
- age between 3 and 18
Who cannot join
- pregnancy/breast feeding
- decreased renal or thyroidal function
- drug intake of Beta-blockers, antispasmodics, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin
- contradictions for MRI
- indication for analgosedation for MRI
- inflammatory bowel diseases
Show all 9Show fewer
- fractures/different anatomy in sacral region
- epilepsy
- presence of cardiac pacemakers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Pediatric Surgery in the Children's Hospital
Erlangen, 91054
Sonja Diez, PD Dr. med., 0049 9131 8532923, sonja.diez@uk-erlangen.de
About this study
Official title: Stimulation Modeling and Adaptive Response Tracking in Pediatric Gastrointestinal Motility Disorders
The goal of this study is to learn about the effects of sacral neuromodulation in pediatric patients with gastrointestinal motility disorders. By combining advanced neuroimaging, patient-specific biophysical modeling, electrophysiological characterization, and clinical translation, the SMART-GUT project establishes a comprehensive framework to systematically investigate neuromodulation in this pediatric population. This integrative approach enables a direct link between mechanism, targeting, and clinical outcome.
Read the detailed description
Patients enrolled in the study will be receiving sacral neuromodulation (via surgical implantation) and MRIs prior to neuromodulation treatment and after 12 weeks. In cases of surgical implantation, the intraoperative testing is accompanied by a broad neuronal evaluation (The goal is to establish with these informations
- improved understanding of interindividual sacral nerval anatomy
- improved guidelines for implantation of sacral neuromodulation via 3D reconstructions (digital twins)
- prediction of neural activation by sacral neuromodulation and improvement of response rates
- mechanism guided implantation based on clinical symptoms (fecal incontinence vs. leading constipative symptoms)
- improvement of therapeutic efficacy in comparison to non-guided implantation
- Conditions
- Gastrointestinal Motility Disorders in Children, Hirschsprung Disease, Constipation - Functional
- Being tested
- SNM/MRI/EMG
- Keywords
- pediatric gastrointestinal motility disorders, chronic constipation, Hirschsprung disease, sacral neuromodulation
- Medical subject headings
- Hirschsprung Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNM/MRI/EMGProcedure or surgery
Participants are receiving clinical baseline evaluation, preoperative sacral and functional MRI, reconstruction of digital twin, surgical implantation of sacral neuromodulation including intraoperative testing, postoperative sacral and functional MRI, and clinical follow-up
| Study group | Role | What they receive |
|---|---|---|
| SNM-guided implantation | Active comparator | Surgical implantation of sacral neuromodulation after generation of digital twin and intraoperative efficacy testing Receives: Procedure: SNM/MRI/EMG |
| SNM | No intervention | SNM implantation based on general knowledge and adult measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal incontinence
Changes in the frequency and intensity of fecal incontinence, assessed by specialized questionnaires for patients and parents and analyzed per day (scale >1x/d; 1x/d; 2-3x/week; 1x/week; <1x/week and classified as soiling/encopresis)
Measured: Within 12 weeks of sacral neuromodulation
Abdominal pain
Changes in the frequency and intensity of abdominal pain, , assessed by specialized questionnaires for patients and parents (NRS scale, 0 no pain - 10 maximum pain) and analyzed as episodes per day
Measured: Within 12 weeks of sacral neuromodulation
Defecation frequency
Changes in defecation frequency per week, assessed by specialized questionnaires for patients and parents (scale >1x/d; 1x/d; 2-3x/week; 1x/week; <1x/week and classified regarding consistency based on Bristol Stool Scale (1 hard stool - 7 fluid stool))
Measured: Within 12 weeks of sacral neuromodulation
Urinary incontinence
Changes in frequency and intensity of urinary incontinence, assessed by specialized questionnaires for patients and parents and analyzed per day (scale >1x/d; 1x/d; 2-3x/week; 1x/week; <1x/week)
Measured: Within 12 weeks of sacral neuromodulation
Proprioception
Changes in the proprioception of urge to defecate, assessed by specialized questionnaires for patients and parents and analyzed per day (scale normal urge to defecate without soiling/encopresis; rare urge to defecate with soiling/encopresis; no urge to defecate with soiling/encopresis)
Measured: Within 12 weeks of sacral neuromodulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Jul 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Motility Disorders in ChildrenStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Sonja Diez, Friedrich-Alexander-Universität Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519915
- Sponsor's protocol ID
- SMART-GUT_V1
- Acronym
- SMART-GUT
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared on reasonable request.
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
- Stimulation Modeling and Adaptive Response Tracking in Pediatric Gastrointestinal Motility Disorders
- ClinicalTrials.gov ID
- NCT07519915
- Acronym / sponsor ID
- SMART-GUT / SMART-GUT_V1
- Conditions
- Gastrointestinal Motility Disorders in Children, Hirschsprung Disease, Constipation - Functional
- Keywords
- pediatric gastrointestinal motility disorders, chronic constipation, Hirschsprung disease, sacral neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Friedrich-Alexander-Universität Erlangen-NürnbergUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 Apr 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.
The goal of this study is to learn about the effects of sacral neuromodulation in pediatric patients with gastrointestinal motility disorders. By combining advanced neuroimaging, patient-specific biophysical modeling, electrophysiological characterization, and clinical translation, the SMART-GUT project establishes a comprehensive framework to systematically investigate neuromodulation in this pediatric population. This integrative approach enables a direct link between mechanism, targeting, and clinical outcome.
Detailed description
Patients enrolled in the study will be receiving sacral neuromodulation (via surgical implantation) and MRIs prior to neuromodulation treatment and after 12 weeks. In cases of surgical implantation, the intraoperative testing is accompanied by a broad neuronal evaluation (The goal is to establish with these informations
- improved understanding of interindividual sacral nerval anatomy
- improved guidelines for implantation of sacral neuromodulation via 3D reconstructions (digital twins)
- prediction of neural activation by sacral neuromodulation and improvement of response rates
- mechanism guided implantation based on clinical symptoms (fecal incontinence vs. leading constipative symptoms)
- improvement of therapeutic efficacy in comparison to non-guided implantation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNM-guided implantation | Active comparator | Procedure: SNM/MRI/EMGSurgical implantation of sacral neuromodulation after generation of digital twin and intraoperative efficacy testing |
| SNM | No intervention | –SNM implantation based on general knowledge and adult measurements |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- informed consent of patient and care taker
- gastrointestinal motility disorder, disregarding underlying diseases
- exclusion of mechanical obstructions in the gastrointestinal passage
- age between 3 and 18
Key exclusion criteria (9 listed)
- pregnancy/breast feeding
- decreased renal or thyroidal function
- drug intake of Beta-blockers, antispasmodics, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin
- contradictions for MRI
- indication for analgosedation for MRI
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 |
|---|---|---|
| SNM/MRI/EMGParticipants are receiving clinical baseline evaluation, preoperative sacral and functional MRI, reconstruction of digital twin, surgical implantation of sacral neuromodulation including intraoperative testing, postoperative sacral and functional MRI, and clinical follow-up | Procedure or surgery | SNM-guided implantation |
Primary outcome
Fecal incontinence
Time frame: Within 12 weeks of sacral neuromodulation
Changes in the frequency and intensity of fecal incontinence, assessed by specialized questionnaires for patients and parents and analyzed per day (scale >1x/d; 1x/d; 2-3x/week; 1x/week; <1x/week and classified as soiling/encopresis)
Abdominal pain
Time frame: Within 12 weeks of sacral neuromodulation
Changes in the frequency and intensity of abdominal pain, , assessed by specialized questionnaires for patients and parents (NRS scale, 0 no pain - 10 maximum pain) and analyzed as episodes per day
Defecation frequency
Time frame: Within 12 weeks of sacral neuromodulation
Changes in defecation frequency per week, assessed by specialized questionnaires for patients and parents (scale >1x/d; 1x/d; 2-3x/week; 1x/week; <1x/week and classified regarding consistency based on Bristol Stool Scale (1 hard stool - 7 fluid stool))
Urinary incontinence
Time frame: Within 12 weeks of sacral neuromodulation
Changes in frequency and intensity of urinary incontinence, assessed by specialized questionnaires for patients and parents and analyzed per day (scale >1x/d; 1x/d; 2-3x/week; 1x/week; <1x/week)
Proprioception
Time frame: Within 12 weeks of sacral neuromodulation
Changes in the proprioception of urge to defecate, assessed by specialized questionnaires for patients and parents and analyzed per day (scale normal urge to defecate without soiling/encopresis; rare urge to defecate with soiling/encopresis; no urge to defecate with soiling/encopresis)
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 9 Apr 2026.
- Individual participant dataSharing planned: Yes. Data can be shared on reasonable request.
Related trials for Gastrointestinal Motility Disorders in Children
Not yet recruiting
Comparison of a New Non-invasive Device With the Invasive Gold-standard Investigation to Assess Function of the Large Bowel in Children
Bowel Dysfunction, Dysmotility
Recruiting
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
Gastroesophageal Reflux in Children
RecruitingObservational study
Prevalence of Symptomatic Gastroesophageal Reflux Disease in Czech Children (Czech GERDKids)
Gastro Esophageal Reflux
RecruitingObservational study
BSGM to Evaluate Patients With GI Symptoms
Gastrointestinal Motility Disorders in Children, Functional Gastrointestinal Disorders
Recruiting
BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
Infantile Colic, Gastroesophageal Reflux (GER)
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 SNM/MRI/EMG in people with Gastrointestinal Motility Disorders in Children and Hirschsprung Disease, run by Friedrich-Alexander-Universität Erlangen-Nürnberg at 1 site in Germany.
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 9 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 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 Germany. 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?
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 Sonja Diez, PD Dr. med. (09131 - 85 32923, sonja.diez@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal incontinence (time frame: Within 12 weeks of sacral neuromodulation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.