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Completed

NCT Number: NCT02524262

L-cysteine Prevents Stomach Exposure to Carcinogenic Acetaldehyde

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.

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Key information

Conditions

Gastritis, Atrophic Digestive System Diseases Gastritis Gastroenteritis Gastrointestinal Diseases Stomach Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Uppsala University

Uppsala, Uppsala County, 75185, Sweden

About this study

Gastric infection with Helicobacter pylori induces chronic active gastritis which over the years develop atrophic gastritis with a hypochlorhydric milieu which is a risk factor for gastric cancer. Microbes colonizing acid-free stomach oxidize ethanol into acetaldehyde, considered a group 1 carcinogen.

The aim of the study is to assess the 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. Identical placebo tablets will be used for comparison.

Patients with biopsy-confirmed atrophic gastritis, low serum pepsinogen and high gastrin-17 will be studied with case-control design. All subjects will be their own control. On separate days, patients are randomly assigned to receive 200 mg slow-release L-cysteine or placebo, then have intragastric instillation of 15% (0.3 g/kg) ethanol (corresponding to two glasses of wine). After intake, gastric sampling of fluid for a period of four hours is done and concentrations of acetaldehyde, ethanol, L-cysteine and MTCA are analysed.

L-cysteine is expected to decrease gastric acetaldehyde concentrations and increase the MTCA level. Gastric L-cysteine and MTCA concentrations are expected to be maintained over the study period. With placebo, acetaldehyde is expected to be elevated along with ethanol concentrations.

Based on these assumptions slow-release L-cysteine binds acetaldehyde to form inactive MTCA, which remains in gastric juice resulting in reduced local exposure of the gastric mucosa to carcinogenic acetaldehyde.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Helicobacter-associated chronic gastritis
  • Hypochlorhydria
  • Hypergastrinemia
  • Hypopepsinogenemia

Exclusion criteria

  • Active peptic ulcer disease
  • Other inflammatory gastrointestinal disease
  • Gastrointestinal bleeding
  • Gastrointestinal surgery
  • Neurological disease
  • Alcohol abuse
  • Mental disorder
  • Not able to sign informed consent

Treatment and study plan

Slow-release L-cysteine

Dietary Supplement

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

Other names: Acetium

Primary outcomes

  1. Acetaldehyde concentrations in the stomach

    Time frame: 4 hours

    Binding of acetaldehyde to L-cysteine

Secondary outcomes

  1. 4-methyltiazolidine-2-carboxylic acid concentration in the stomach

    Time frame: 4 hours

    Production of inert 4-methyltiazolidine-2-carboxylic acid after binding to L-cysteine

Sponsors and collaborators

Lead sponsor

Per Hellström

Other

Collaborators

  • Biohit Oyj, Helsinki, Finland
  • CTC Clinical Trial Consultants AB
  • University of Helsinki
  • Åbo Akademi University

Registry information

Official study title

Slow-release L-cysteine Capsule Prevents Carcinogenic Gastric Acetaldehyde Exposure in Helicobacter-associated Atrophic Gastritis

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 14, 2015
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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