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L-cysteine Prevents Stomach Exposure to Carcinogenic Acetaldehyde

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ClinicalTrials.gov Identifier: NCT02524262
Recruitment Status : Completed
First Posted : August 14, 2015
Last Update Posted : January 25, 2016
Sponsor:
Collaborators:
Biohit Oyj, Helsinki, Finland
Helsinki University
Åbo Akademi University
Clinical Trial Consultants, Uppsala, Sweden
Information provided by (Responsible Party):
Per Hellström, Uppsala University

Brief 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.


Condition or disease Intervention/treatment Phase
Gastritis, Atrophic Dietary Supplement: Slow-release L-cysteine Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Slow-release L-cysteine Capsule Prevents Carcinogenic Gastric Acetaldehyde Exposure in Helicobacter-associated Atrophic Gastritis
Study Start Date : December 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Slow-release L-cysteine
Oral intake of slow-release L-cysteine 200 mg before challenge with ethanol.
Dietary Supplement: Slow-release L-cysteine
Bind and inactivate acetaldehyde formed from ethanol by covalent binding to L-cysteine
Other Name: Acetium

Placebo Comparator: Placebo
Oral intake of identically-looking placebo capsules
Dietary Supplement: Slow-release L-cysteine
Bind and inactivate acetaldehyde formed from ethanol by covalent binding to L-cysteine
Other Name: Acetium




Primary Outcome Measures :
  1. Acetaldehyde concentrations in the stomach [ Time Frame: 4 hours ]
    Binding of acetaldehyde to L-cysteine


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524262


Locations
Sweden
Uppsala University
Uppsala, Uppsala county, Sweden, 75185
Sponsors and Collaborators
Per Hellström
Biohit Oyj, Helsinki, Finland
Helsinki University
Åbo Akademi University
Clinical Trial Consultants, Uppsala, Sweden
Investigators
Principal Investigator: Per M Hellstrom, MD, PhD Uppsala University

Responsible Party: Per Hellström, Professor, Uppsala University
ClinicalTrials.gov Identifier: NCT02524262     History of Changes
Other Study ID Numbers: 620070-SWE-2012
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: World J Gastroenterol

Keywords provided by Per Hellström, Uppsala University:
atrohpic gastritis
acetaldehyde
ethanol
L-cysteine

Additional relevant MeSH terms:
Atrophy
Gastritis
Gastritis, Atrophic
Pathological Conditions, Anatomical
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs