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Recruiting NCT06539494

Luminal Fructose Kinetics (MARTINI Study)

Phase II Interventional MASLD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Omeprazole 40 MG.
Who it may be relevant to
Registry conditions: MASLD. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Luminal Fructose Kinetics (MARTINI) (2024)

Overview

In this study the investigators aim is to explore the dynamics of (small) intestinal fructose catabolism in humans and ethanol production in relation to small intestinal signalling pathways and changes in pH, using 13C fructose isotope tracing techniques complemented with direct luminal sampling via small intestinal catheter in biopsy proven MASLD/MASH patients vs healthy (BMI\<25) subjects. Additionally the investigators will repeat the experiment after four weeks of administering omeprazole at a dose of 40 mg twice daily. Omeprazole is a proton pump inhibitor, known to elevate pH from 2-6.

Detailed description

The investigators will perform a non blinded single centre intervention study in 2x 11 participants

Participants will be either healthy volunteers with a BMI \< 25 and Age 18-65 or patients with MASLD with a BMI \>25, Age 18-65

The objective of the investigators is to study the fructose host/microbial kinetics in humans and to establish the role of (small) intestinal pH on fructose fermentation and endogenous ethanol production in a MASLD/MASH population versus healthy subjects

Subjects will be given omeprazole orally given twice a day 40mg for four weeks

At baseline and after four weeks of omeprazole, a fructose challenge test with labelled fructose and fomepizole and a gastroscopy will be performed, during which a nasal-intestinal catheter will be placed to allow for luminal sampling during the fructose challenge test.

Interventions

  • Drug Omeprazole 40 MG
    Proton pump inhibitor twice a day for 4 weeks

Primary outcome measures

  • Changes in ethanol concentrations before and after omeprazol usage [Time frame: four weeks]
  • Changes in fructose concentrations in peripheral blood before and after omeprazol usage [Time frame: 4 weeks]
  • Changes in fructose metabolites in breath before and after omeprazol usage [Time frame: 4 weeks]
  • Fructose metabolites in feces before and after omeprazol usage [Time frame: 4 weeks]
  • Fructose metabolites in urine [Time frame: 4 weeks]
  • Changes in serum glucose concentrations before and after omeprazol [Time frame: 4 weeks]
Secondary outcome measures (7)
  • Changes in microbiota composition in luminal samples [Time frame: four weeks]
  • Changes in dietary intake [Time frame: four weeks]
  • Bioreactor analyses [Time frame: four weeks]
  • Changes in Oral microbiota composition [Time frame: four weeks]
  • Differences in gene expression in small intestinal biopsies [Time frame: 4 weeks]
  • Changes in Fecal microbiota composition [Time frame: 4 weeks]
  • Changes in abundance of post prandial plasma metabolites [Time frame: 4 weeks]

Eligibility criteria

Inclusion criteria

In case of the healthy subject group:

  • Adult individuals, age > 18 <65 years
  • Male or postmenopauzal females
  • BMI <25
  • Ability to give informed consent In case of the MASLD/MASH group
  • Adult individuals, age > 18 <65 years
  • Male or postmenopauzal females
  • BMI > 25
  • Biopsy proven MASLD/MASH
  • Ability to give informed consent

Exclusion criteria

  • History of sustained excess alcohol ingestion: daily consumption >30g/day (3 drinks per day) for males and >20 g/day (2 drinks per day) for females
  • Patients with diabetes
  • Bariatric surgery
  • Other forms of liver disease (e.g. Hepatitis B,C, Wilson disease, hemochromatosis)
  • Proton-pump inhibitor usage one year prior to study participation
  • GLP1, SGLT2i or insulin use
  • Antibiotic use for the past 3 months
  • Probiotic or symbiotic usage
  • Pregnant women
  • Chronic illness (including a known history of heart failure, renal failure (eGFR <30 ml/min), pulmonary disease, gastrointestinal disorders, or hematologic diseases), or other inflammatory diseases
  • Active infection
  • Use of ascal, clopidogrel or other platelet inhibition
  • Smoking
  • Blood thinners
  • Heart failure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Netherlands · 1 center
  • Amsterdam UMC location AMC — Amsterdam

Identifiers

NCT: NCT06539494 · NL85966.018.23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗