AzTrials
AzTrials

Chronic ConstipationNCT06911749

MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders

A study testing MSOT with ICG and MRI in people with Chronic Constipation and Slow Transit Constipation, run by Dr. med. Sonja Diez at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The project presented here is a monocentric clinical study conducted by the Pediatric Surgery and Pediatrics departments of the University Hospital Erlangen. The study aims to experimentally expand the diagnostic approach for patients aged 0-17 years suffering from chronic bowel emptying disorders, regardless of any… Read more about this study

Who is it for?
Ages 1 year and olderHealthy volunteers can take part
What is being tested?
MSOT with ICG and MRI
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteGermany
Study dates
15 Apr 2025to 1 Jun 2026
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 1 year and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Patient Group
  • Written informed consent from the participant (starting at age 6).
  • Written informed consent from the legal guardian(s).
  • Suspected or confirmed diagnosis of chronic defecation disorder.
  • Age ≤ 18 years.
  • Willingness and ability to participate, with sufficient German language skills to understand the informed consent document.
Show all 11Show fewer
  • Control Group
  • Written informed consent from the participant.
  • Age > 18 years.
  • BMI < 25 or medical suitability for MSOT examination as assessed by a physician.
  • Willingness and ability to participate, with sufficient German language skills to understand the informed consent document.

Who cannot join

  • Age < 1 year.
  • Pregnancy or breastfeeding.
  • Tattoos in the examination area.
  • Subcutaneous fat tissue thickness > 3 cm.
  • Known hypersensitivity to ICG, sodium iodide, or iodine.
  • Thyroid dysfunction, including hyperthyroidism or focal/diffuse thyroid autonomy.
Show all 28Show fewer
  • Recent thyroid function testing with radioactive iodine treatment (within two weeks before or after the study).
  • Impaired renal function.
  • Use of specific medications, including:
  • Beta-blockers,
  • Anticonvulsants,
  • Cyclopropane,
  • Bisulfite compounds,
  • Haloperidol,
  • Heroin,
  • Meperidine,
  • Metamizole,
  • Methadone,
  • Morphine,
  • Nitrofurantoin,
  • Opium alkaloids,
  • Phenobarbital,
  • Phenylbutazone,
  • Probenecid,
  • Rifamycin,
  • Any injection containing sodium bisulfite.
  • General contraindications for MRI, such as electrical implants (e.g., pacemakers, perfusion pumps).
  • Severe claustrophobia preventing MRI examination.

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
  • University Hospital Erlangen, Pediatric Surgery

    Erlangen, Bavaria, 91054

    Recruiting

Other trials in Germany

About this study

Official title: Contrast Enhanced Multispectral Optoacoustic Tomography and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders

The project presented here is a monocentric clinical study conducted by the Pediatric Surgery and Pediatrics departments of the University Hospital Erlangen. The study aims to experimentally expand the diagnostic approach for patients aged 0-17 years suffering from chronic bowel emptying disorders, regardless of any underlying causal or previously treated conditions.

At the core of this clinical study is the application of Multispectral Optoacoustic Tomography (MSOT) in combination with the oral contrast agent Indocyanine Green (ICG) to measure gastrointestinal transit time in children. Unlike conventional X-ray diagnostics, MSOT is radiation-free and considered non-invasive, although it has not yet been standardized for routine clinical use. Additionally, a contrast-free, non-invasive MRI technique will be employed to assess the peristalsis of intestinal segments.

Read more

The study aims to standardize the collection and evaluation of patient data following the administration of ICG and subsequent measurements using MSOT and MRI. The objective is to assess gastrointestinal transit time and peristalsis and, ultimately, to optimize therapy for affected patients. This is of particular importance in the coloproctology specialist consultation within the Pediatric Surgery and Pediatrics departments, as follows:

It enables differentiation between patients with slow transit constipation and outlet obstruction.

It allows for a more targeted application and evaluation of neuromodulation therapy, which is used within clinical studies.

This approach allows for the identification of specific intestinal segments with delayed transit time, enabling targeted electrical stimulation of these regions.

A control group of healthy adult volunteers will participate in the study on a voluntary basis.

Read the detailed description

The term chronic defecation disorders encompasses a wide range of conditions in the current medical literature. Among them, idiopathic chronic constipation represents the central subgroup of patients, often suffering from therapy-refractory symptoms. However, other causes of chronic defecation disorders must also be considered, such as Hirschsprung's disease, cystic fibrosis, congenital malformations and their postoperative complications, or neurogenic bladder and rectal emptying disorders. Additionally, chronic fissures, congenital anal stenosis, and previous abdominal surgeries can contribute to chronic defecation disorders.

In most cases, the underlying cause is not a single, well-controlled symptom but rather a heterogeneous symptom complex. Chronic constipation, for instance, is defined based on various symptoms as per the Rome IV criteria, requiring a duration of at least three months for diagnosis. In children, this condition frequently presents as a combination of defecation difficulties, severe abdominal pain, food refusal, encopresis, enuresis, and reduced activity levels, often necessitating a multimodal and sometimes highly burdensome therapy. Patients typically experience significant distress and markedly reduced quality of life.

The prevalence of chronic constipation in children and adolescents is high, with reported rates reaching up to 34%. However, in more than 90% of cases, no organic cause can be identified. Conservative treatment approaches are often inadequate or fail to prevent long-term chronicity. Despite this, defecation disorders in children and adolescents are frequently underestimated and sometimes managed within psychiatric treatment settings, which may lead to long-term physical and psychological developmental impairments.

Diagnostic Challenges

Following the exclusion of manifest organic causes, the differentiation between "slow transit constipation" (STC) and "outlet obstruction" (OO) remains a major diagnostic challenge in children. Further complicating matters, many pediatric patients exhibit mixed forms of both conditions.

Slow transit constipation (STC) is characterized by a generalized delay in bowel transit, with predominantly genetic but also other organic causes. This condition arises from innervation disorders of the intestine, dysfunctions of the autonomic nervous system, abnormalities in the smooth muscle layers of the intestinal wall, as well as endocrine and metabolic dysfunctions. Typical symptoms include severe constipation, chronic abdominal pain, and therapy-resistant fecal incontinence.

Outlet obstruction (OO), in contrast, is caused by impaired stool evacuation at the anal level, often due to dyssynergic defecation or, less commonly, anatomical obstructions. Currently, a definitive differentiation between STC and OO in clinical practice is rarely performed, as non-invasive diagnostic tools are lacking. The only gold-standard diagnostic procedure available is anorectal manometry, which requires patient cooperation, making it impractical for young children. Additionally, the rectal insertion of probes and balloons renders it an invasive and potentially traumatizing procedure, which can exacerbate symptoms. As a result, a minimum patient age is required, and the findings are often difficult to interpret objectively.

Existing Methods for Transit Time Measurement

The delayed intestinal transit time associated with STC can be evaluated using:

The modified Hinton test Motility capsules Gastrointestinal transit scintigraphy The lactulose hydrogen breath test

In Germany, the modified Hinton test remains the gold standard. This involves ingestion of 10 radiopaque markers per day for six consecutive days, followed by an abdominal X-ray on day seven to calculate the oro-anal transit time. However, this method is time-consuming and should be used with caution in children due to radiation exposure. Other emerging methods include:

SmartPill motility capsules, which measure temperature, pH, and intraluminal pressure to determine total transit time. However, these are not commercially available and do not offer significant advantages over conventional transit studies to justify the additional cost.

Gastrointestinal transit scintigraphy, which involves a technetium-labeled meal and subsequent gamma camera imaging at 1, 2, and 4 hours. However, this method is time-intensive, expensive, and not widely available. Additionally, it is considered invasive and unsuitable for pediatric use due to radiation exposure.

The lactulose hydrogen breath test, which measures the oro-cecal transit time by detecting bacterial fermentation of lactulose in the cecum. However, this method is limited to assessing small bowel transit only.

Notably, none of these tests can differentiate between an organic and a functional cause of constipation.

Multispectral Optoacoustic Tomography (MSOT) for Transit Time Measurement

Multispectral optoacoustic tomography (MSOT) is based on the emission of laser light at multiple near-infrared wavelengths. This light stimulates biological tissue, leading to ultrasound wave emission, which is then reconstructed into an image. MSOT enables the acquisition of both single-wavelength images and spectrally unmixed images, allowing for the visualization of molecules with known absorption properties, such as hemoglobin and lipids.

Contrast-enhanced MSOT (CE-MSOT) allows for non-invasive, radiation-free visualization of chyme passage through the gastrointestinal tract. Studies have demonstrated that orally administered Indocyanine Green (ICG) can be detected at various locations within the GI tract-including the gastric antrum, terminal ileum, and sigmoid colon-using MSOT.

ICG, which has an absorption peak at approximately 800 nm in the near-infrared spectrum, is well-suited for optical imaging techniques. It is already widely used in medical applications, including intraoperative imaging, liver function diagnostics, and cardiovascular assessments.

Although the oral administration of ICG is an off-label use, systemic side effects are highly unlikely, as ICG is not absorbed and does not undergo enterohepatic circulation, according to its official drug information.

The complete gastrointestinal passage of ICG has been confirmed through fluorescence microscopy detection of ICG in stool samples from subjects following oral administration. Based on this methodology, this study aims to evaluate intestinal transit time in patients with chronic defecation disorders, providing a novel, non-invasive diagnostic tool to address the current gap in pediatric gastrointestinal transit assessment.

Study Objective: Combining MSOT and MRI for Comprehensive GI Transit Analysis

This study aims to integrate MRI sequences specifically designed to visualize peristaltic bowel movements with high temporal resolution, allowing for a detailed assessment of peristaltic frequency and patterns across different intestinal segments. By capturing these peristaltic movements, it becomes possible to identify abnormally reduced peristalsis in the pediatric patient cohort.

By combining MSOT-derived transit time measurements with MRI-based peristalsis visualization, this study offers a comprehensive and non-invasive method to assess gastrointestinal motility. Through this approach, it will be possible to detect segments of the intestine with abnormal transit times and assess chyme transport throughout the entire gastrointestinal tract without exposing patients to radiation or invasive procedures.

Being tested
MSOT with ICG, MRI
Keywords
slow transit constipation, MSOT, ICG, gastrointestinal transit, Hirschsprungs Disease
Medical subject headings
Hirschsprung Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MSOT with ICGDiagnostic test

    Application of Multispectral Optoacoustic Tomography (MSOT) in combination with the oral contrast agent Indocyanine Green (ICG) to measure gastrointestinal transit time

  • MRIDiagnostic test

    Non-invasive MRI imaging technique will be employed to assess the peristalsis of intestinal segments

Study groups in NCT06911749
Study groupRoleWhat they receive
Control GroupActive comparatorThe control group consists of young, healthy adults without bowel emptying disorders. The aim of this group is to provide baseline measurements for gastrointestinal transit time and peristalsis using Multispectral Optoacoustic Tomography (MSOT) and MRI, allowing for comparison with the intervention group and ensuring the reliability of the diagnostic approach.
Receives: Diagnostic Test: MSOT with ICG; Diagnostic Test: MRI
Transit Disorder GroupActive comparatorThe intervention group consists of pediatric patients suffering from chronic defecation disorders, including idiopathic chronic constipation, slow transit constipation (STC), and outlet obstruction (OO). The aim of the intervention is to assess gastrointestinal transit time and peristalsis using a novel, non-invasive combination of Multispectral Optoacoustic Tomography (MSOT) and MRI.
Receives: Diagnostic Test: MSOT with ICG; Diagnostic Test: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ICG signal intensitiy

    Measurement of qualitative and quantitative ICG signal within the lumen of the GI tract, expressed in arbitrary units (AU).

    Measured: From enrollment to the end of measurements after one week

  2. MRI-Based Diagnostic Image Quality

    Assessment of overall MRI image quality using a standardized grading scale.

    Measured: From enrollment to the end of measurements after one week

  3. MRI Motion Robustness

    Evaluation of motion artifacts in MRI imaging, scored on a predefined motion robustness scale.

    Measured: Time Frame: From enrollment to the end of measurements after one week.

  4. MRI-Based Peristalsis Frequency

    Measurement of peristaltic contractions per minute in different intestinal segments.

    Measured: Time Frame: From enrollment to the end of measurements after one week

  5. MRI-Based Peristalsis Amplitude

    Quantification of bowel wall movement amplitude in millimeters (mm).

    Measured: Time Frame: From enrollment to the end of measurements after one week.

Secondary outcomes (5)
  1. Single-Wavelength Optoacoustic Signal

    Quantitative assessment of single-wavelength optoacoustic measurements, expressed in arbitrary units (AU).

    Measured: From enrollment to the end of measurements after one week

  2. Optoacoustic Spectrum Analysis

    Comprehensive optoacoustic signal analysis across multiple wavelengths, normalized in arbitrary units (AU).

    Measured: From enrollment to the end of measurements after one week

  3. Ultrasound imaging

    Ultrasound imaging with assement of the presence of stool.

    Measured: From enrollment to the end of measurements after one week

  4. Gastrointestinal Symptom Assessment

    Evaluation of symptom severity, including abdominal pain, nausea, diarrhea, and other gastrointestinal complaints, recorded on a standardized symptom severity scale.

    Measured: From enrollment to the end of the study after one year.

  5. Demographic parameters

    Collection of demographic data, including age (years), height (cm), weight (kg), and other relevant characteristics.

    Measured: From enrollment to the end of measurements after one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2025
  2. Study start15 Apr 2025
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This study is a monocentric observational study with prospective data collection. It is conducted as an Investigator-Initiated Trial (IIT).
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06911749
Sponsor's protocol ID
24-373-B
Other IDs
Ethics Committee FAU
Status last verified
Mar 2025
First submitted
25 Feb 2025
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Paulus LP, Buehler A, Wagner AL, Raming R, Jungert J, Simon D, Tascilar K, Schnell A, Rother U, Eckstein M, Lang W, Hoerning A, Schett G, Neurath MF, Waldner MJ, Trollmann R, Woelfle J, Bohndiek SE, Regensburger AP, Knieling F. Contrast-Enhanced Multispectral Optoacoustic Tomography for Functional Assessment of the Gastrointestinal Tract. Adv Sci (Weinh). 2023 Aug;10(23):e2302562. doi: 10.1002/advs.202302562. Epub 2023 Jun 8.

    PubMed 37289088

Questions about this trial

What is this clinical trial studying?

A study testing MSOT with ICG and MRI in people with Chronic Constipation and Slow Transit Constipation, run by Dr. med. Sonja Diez 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 11 inclusion and 28 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 3 Sep 2025. 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 Frederike Bieling (+49 9131 85 32923, frederike.bieling@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ICG signal intensitiy (time frame: From enrollment to the end of measurements after one week). 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?

On the ClinicalTrials.gov record for NCT06911749, 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 3 Sep 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in