Lactose IntoleranceNCT06617364
MSOT for Assessment of Intestinal Transit Time in Lactose Intolerance Patients
A study testing gastrointestinal transit time measurement using MSOT and ICG contrast agent in people with Lactose Intolerance, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The study aims to investigate gastrointestinal transit using multispectral optoacoustic tomography (MSOT) in a prospective diagnostic study involving patients suspected of primary or secondary lactose intolerance. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Lactose Intolerance
- What is being tested?
- gastrointestinal transit time measurement using MSOT and ICG contrast agent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 11 Nov 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Written informed consent of the subject
- Written informed consent of the subject\'s legal guardian
- Suspicion or diagnosis of lactose intolerance
- Age 6 to 18 years
- General Exclusion Criteria:
- Pregnancy
Show all 17Show fewer
- Breastfeeding mothers
- Tattoo in the examination area
- Subcutaneous fat tissue over 3 cm
- Known hypersensitivity to ICG, sodium iodide, or iodine
- Hyperthyroidism, focal or diffuse thyroid autonomy
- Recent treatment for thyroid function assessment involving radioactive iodine (within two weeks before or after the study)
- Impaired renal function
- Use of the following medications: beta-blockers, anticonvulsants, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin, any injection containing sodium bisulfite
- MRI Exclusion Criteria:
- General contraindications for MRI examinations (e.g., electrical implants such as pacemakers or infusion pumps, etc.)
- Severe claustrophobia
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contrast Enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Intestinal Transit Time in Lactose Intolerance Patients
The study aims to investigate gastrointestinal transit using multispectral optoacoustic tomography (MSOT) in a prospective diagnostic study involving patients suspected of primary or secondary lactose intolerance. These patients exhibit varying clinical symptoms and different results from the hydrogen breath test (H2 breath test).
Lactose intolerance is caused by a deficiency in the enzyme lactase, which is responsible for breaking down lactose into glucose and galactose. Without this breakdown, lactose is fermented by colon bacteria, leading to symptoms such as bloating and diarrhea. The prevalence of lactose intolerance is increasing, especially among children, and the current diagnostic gold standard is the hydrogen breath test, which, while specific, has limitations in sensitivity.
Read more
MSOT could fill this diagnostic gap by non-invasively measuring intestinal transit time and providing a more objective assessment of the condition.
The study will compare MSOT results with H2 breath test outcomes, particularly focusing on patients with varying disease durations and activity levels.
Additionally, participants are offered an optional MRI examination, which can be used to measure intestinal motility. This helps to further quantify the results of the MSOT examination and discover new findings regarding the extent of the disease.
MSOT could improve the sensitivity of lactose intolerance diagnosis, differentiate it from other conditions, and offer insights into disease management over time.
- Conditions
- Lactose Intolerance
- Being tested
- gastrointestinal transit time measurement using MSOT and ICG contrast agent
- Keywords
- MSOT, lactose intolerance, pediatric, ICG, gastrointestinal transit
- Medical subject headings
- Lactose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastrointestinal transit time measurement using MSOT and ICG contrast agentProcedure or surgery
The subject arrives at the clinic in the morning, fasting according to the preparation instructions from the Childrens Hospital Erlangen for the H2 breath test. Before taking the liquid containing lactose and ICG, the first measurement is performed using MSOT, followed by the H2 breath test. After the liquid to be detected is fully consumed, the second H2 breath test measurement, which only takes a few minutes, is conducted. According to the official guidelines of the Childrens Hospital Erlangen, the hydrogen concentration in the breath is measured at 30-minute intervals. During the 30-minute breaks, further MSOT measurements are carried out, also at 30-minute intervals. Each of these only takes about 10 minutes, they do not interfere with the H2 breath test measurement routine. After the ninth and final H2 breath test measurement a final MSOT examination is conducted. Afterwards participants are offered an optional MRI examination, which can be used to measure intestinal motility.
| Study group | Role | What they receive |
|---|---|---|
| pediatric patients with suspected lactose intolerance | Experimental | On the one hand the patients will undergo the hydrogen breath test and on the other their gastrointestinal transit time will be measured using MSOT and ICG contrast agent. Receives: Procedure: gastrointestinal transit time measurement using MSOT and ICG contrast agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICG-Signal in the intestinal tract
measured be MSOT
Measured: 1 day
Secondary outcomes (2)
Hydrogen breath test results
measured in ppm
Measured: 1 day
MRI
peristaltic metrics
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start11 Nov 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
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 Lactose IntoleranceStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferdinand Knieling, University Hospital Erlangen
- Investigators
- Adrian Regensburger, PD Dr. med. Dr. rer. biol. hum, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617364
- Sponsor's protocol ID
- MSOT_ICG_LI
- Status last verified
- Nov 2024
- First submitted
- 24 Sep 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caselitz L, Classen M, Buhler A, Paulus LP, Grieshaber-Bouyer Mandelbaum H, Nedoschill E, Wolfle J, Horning A, Knieling F, Regensburger AP, Wachter F. Non-invasive measurement of accelerated gastrointestinal transit in pediatric patients using Contrast-enhanced Multispectral optoacoustic tomography. Npj Imaging. 2026 May 4;4(1):32. doi: 10.1038/s44303-026-00169-4.
PubMed 42082671
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Intestinal Transit Time in Lactose Intolerance Patients
- ClinicalTrials.gov ID
- NCT06617364
- Acronym / sponsor ID
- MSOT_ICG_LI
- Conditions
- Lactose Intolerance
- Keywords
- MSOT, lactose intolerance, pediatric, ICG, gastrointestinal transit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 27 Sep 2024 (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 study aims to investigate gastrointestinal transit using multispectral optoacoustic tomography (MSOT) in a prospective diagnostic study involving patients suspected of primary or secondary lactose intolerance. These patients exhibit varying clinical symptoms and different results from the hydrogen breath test (H2 breath test).
Lactose intolerance is caused by a deficiency in the enzyme lactase, which is responsible for breaking down lactose into glucose and galactose. Without this breakdown, lactose is fermented by colon bacteria, leading to symptoms such as bloating and diarrhea. The prevalence of lactose intolerance is increasing, especially among children, and the current diagnostic gold standard is the hydrogen breath test, which, while specific, has limitations in sensitivity.
MSOT could fill this diagnostic gap by non-invasively measuring intestinal transit time and providing a more objective assessment of the condition.
The study will compare MSOT results with H2 breath test outcomes, particularly focusing on patients with varying disease durations and activity levels.
Additionally, participants are offered an optional MRI examination, which can be used to measure intestinal motility. This helps to further quantify the results of the MSOT examination and discover new findings regarding the extent of the disease.
MSOT could improve the sensitivity of lactose intolerance diagnosis, differentiate it from other conditions, and offer insights into disease management over time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric patients with suspected lactose intolerance | Experimental | Procedure: gastrointestinal transit time measurement using MSOT and ICG contrast agentOn the one hand the patients will undergo the hydrogen breath test and on the other their gastrointestinal transit time will be measured using MSOT and ICG contrast agent. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- Written informed consent of the subject
- Written informed consent of the subject\'s legal guardian
- Suspicion or diagnosis of lactose intolerance
- Age 6 to 18 years
- Pregnancy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| gastrointestinal transit time measurement using MSOT and ICG contrast agentThe subject arrives at the clinic in the morning, fasting according to the preparation instructions from the Childrens Hospital Erlangen for the H2 breath test. Before taking the liquid containing lactose and ICG, the first measurement is performed using MSOT, followed by the H2 breath test. After the liquid to be detected is fully consumed, the second H2 breath test measurement, which only takes a few minutes, is conducted. According to the official guidelines of the Childrens Hospital Erlangen, the hydrogen concentration in the breath is measured at 30-minute intervals. During the 30-minute breaks, further MSOT measurements are carried out, also at 30-minute intervals. Each of these only takes about 10 minutes, they do not interfere with the H2 breath test measurement routine. After the ninth and final H2 breath test measurement a final MSOT examination is conducted. Afterwards participants are offered an optional MRI examination, which can be used to measure intestinal motility. | Procedure or surgery | pediatric patients with suspected lactose intolerance |
Primary outcome
ICG-Signal in the intestinal tract
Time frame: 1 day
measured be MSOT
2 secondary outcomes
Hydrogen breath test results
Time frame: 1 day
MRI
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Derived from this study: PubMed 42082671Caselitz L, Classen M, Buhler A, Paulus LP, Grieshaber-Bouyer Mandelbaum H, Nedoschill E, Wolfle J, Horning A, Knieling F, Regensburger AP, Wachter F. Non-invasive measurement of accelerated gastrointestinal transit in pediatric patients using Contrast-enhanced Multispectral optoacoustic tomography. Npj Imaging. 2026 May 4;4(1):32. doi: 10.1038/s44303-026-00169-4.
- Individual participant dataSharing planned: No
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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.
Adrian Regensburger, PD Dr. med. Dr. rer. biol. hum study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gastrointestinal transit time measurement using MSOT and ICG contrast agent in people with Lactose Intolerance, run by University of Erlangen-Nürnberg Medical School 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 17 inclusion and 0 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 11 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ICG-Signal in the intestinal tract (time frame: 1 day). 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 NCT06617364, 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 11 May 2025.