MSOT for Assessment of Intestinal Transit Time in Lactose Intolerance Patients

NCT ID: NCT06617364

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-11
• Study Completion Date: 2025-04-30

Brief 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. 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.

Conditions

Lactose Intolerance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

pediatric patients with suspected lactose intolerance

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.

Group Type: EXPERIMENTAL

gastrointestinal transit time measurement using MSOT and ICG contrast agent

Intervention Type: PROCEDURE

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.

Interventions

gastrointestinal transit time measurement using MSOT and ICG contrast agent

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Pregnancy
• 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

• General contraindications for MRI examinations (e.g., electrical implants such as pacemakers or infusion pumps, etc.)
• Severe claustrophobia

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Ferdinand Knieling

PD Dr. med. Dr. rer. biol. hum.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adrian Regensburger, PD Dr. med. Dr. rer. biol. hum

Role: STUDY_CHAIR

Locations

University Hospital Erlangen

Erlangen, Bavaria, Germany

Countries

Germany

Other Identifiers

MSOT_ICG_LI

Identifier Type: -

Identifier Source: org_study_id