NCT06617364

MSOT for Assessment of Intestinal Transit Time in Lactose Intolerance Patients

Contrast Enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Intestinal Transit Time in Lactose Intolerance Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2024-11-11
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2024-09-27
• Last updated: 2025-05-11

Locations

1 site across 1 country: Germany