L-cysteine Prevents Stomach Exposure to Carcinogenic Acetaldehyde

NCT02524262 | Completed Phase 2

• 1 other identifier: 620070-SWE-2012
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastritis, Atrophic

Keywords

atrohpic gastritis; acetaldehyde; ethanol; L-cysteine

Outcome Measures

Primary Outcomes (1)

• Acetaldehyde concentrations in the stomach

  Binding of acetaldehyde to L-cysteine

  4 hours

Secondary Outcomes (1)

• 4-methyltiazolidine-2-carboxylic acid concentration in the stomach

  4 hours

Study Arms (2)

Slow-release L-cysteine

EXPERIMENTAL

Oral intake of slow-release L-cysteine 200 mg before challenge with ethanol.

Dietary Supplement: Slow-release L-cysteine

Placebo

PLACEBO COMPARATOR

Oral intake of identically-looking placebo capsules

Dietary Supplement: Slow-release L-cysteine

Interventions

Slow-release L-cysteine DIETARY_SUPPLEMENT

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

Also known as: Acetium

Placebo; Slow-release L-cysteine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Per Hellström: lead
• Biohit Oyj, Helsinki, Finland: collaborator
• University of Helsinki: collaborator
• Åbo Akademi University: collaborator
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (1)

Uppsala University

Uppsala, Uppsala County, 75185, Sweden

Location

MeSH Terms

Conditions

Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Per M Hellstrom, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 14, 2015
• Study Start: December 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 25, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)