NCT06617364

MSOT for Assessment of Intestinal Transit Time in Lactose Intolerance Patients

Completed NA Last updated 11 May 2025

What this trial tests

NA trial testing gastrointestinal transit time measurement using MSOT and ICG contrast agent in Lactose Intolerance in 10 participants. Completed in 30 April 2025.

Timeline

11 November 2024

Primary endpoint
30 April 2025

30 April 2025

Quick facts

Lead sponsor	University of Erlangen-Nürnberg Medical School
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	10
Start date	11 November 2024
Primary completion	30 April 2025
Estimated completion	30 April 2025
Sites	1 location across Germany

Drugs / interventions tested

• gastrointestinal transit time measurement using MSOT and ICG contrast agent

Conditions studied

• Lactose Intolerance — all drugs for Lactose Intolerance →

Sponsor

University of Erlangen-Nürnberg Medical School

Who can join

Adults 6 to 18, any sex, with Lactose Intolerance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Non-invasive measurement of accelerated gastrointestinal transit in pediatric patients using Contrast-enhanced Multispectral optoacoustic tomography.
   Caselitz L, Claßen M, Bühler A, Paulus LP, et al · · 2026 · PMID 42082671 · DOI 10.1038/s44303-026-00169-4