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L-cysteine Prevents Stomach Exposure to Carcinogenic Acetaldehyde

NCT02524262 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-01-25

No results posted yet for this study

Summary

Atrophic gastritis with hypochlorhydric milieu is a risk factor for gastric cancer. Microbes colonizing the acid-free stomach oxidize ethanol into acetaldehyde, a group 1 carcinogen. The aim is to assess gastric production of acetaldehyde and its inert condensation product, non-toxic 4-methyltiazolidine-2-carboxylic acid (MTCA), after alcohol intake under treatment with slow-release L-cysteine or placebo.

Patients with biopsy-confirmed atrophic gastritis, low serum pepsinogen and high gastrin-17 are studied. On separate days, patients will be randomly assigned to receive 200 mg slow-release L-cysteine or placebo, then have intragastric instillation of 15% (0.3 g/kg) ethanol. After intake, gastric concentrations of acetaldehyde, ethanol, L-cysteine and MTCA are analysed for 4 hours.

Expected results show mitigated exposure of the gastric mucosa to acetaldehyde.

Conditions

  • Gastritis, Atrophic

Interventions

DIETARY_SUPPLEMENT

Slow-release L-cysteine

Bind and inactivate acetaldehyde formed from ethanol by covalent binding to L-cysteine

Sponsors & Collaborators

  • Biohit Oyj, Helsinki, Finland

    collaborator UNKNOWN

  • University of Helsinki

    collaborator OTHER

  • Åbo Akademi University

    collaborator OTHER

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • Per Hellström

    lead OTHER

Principal Investigators

  • Per M Hellstrom, MD, PhD · Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02524262 on ClinicalTrials.gov