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临床试验/NCT06617364
NCT06617364已完成不适用

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

University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
ICG-Signal in the intestinal tract

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

ICG-Signal in the intestinal tract

时间窗: 1 day

measured be MSOT

次要结局

  • Hydrogen breath test results(1 day)
  • MRI(1 day)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ferdinand Knieling

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

University Hospital Erlangen

研究点 (2)

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