L-cysteine Prevents Stomach Exposure to Carcinogenic Acet... | NCT02524262

Studies
L-cysteine Prevents Stomach Exposure to Carcinogenic Acetaldehyde

NCT02524262

Sponsor

Per Hellström

Status

Completed

Last Update Posted

Jan 25, 2016Estimated

Enrollment

8Actual

Phase

Phase 2

Conditions

Gastritis, Atrophic

Interventions

Slow-release L-cysteine

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Aug 13, 2015

First Submission Date that Met QC Criteria

Aug 13, 2015

First Posted Date

Aug 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2016

Last Update Posted Date

Jan 25, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Per Hellström, Professor, Uppsala UniversitySponsor-Investigator

Lead Sponsor

Per HellströmOTHER

Collaborators

Name	Class
Biohit Oyj, Helsinki, Finland	UNKNOWN
University of Helsinki	OTHER
Åbo Akademi University	OTHER
CTC Clinical Trial Consultants AB

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Slow-release L-cysteine	Dietary Supplement	Bind and inactivate acetaldehyde formed from ethanol by covalent binding to L-cysteine	Placebo Slow-release L-cysteine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acetaldehyde concentrations in the stomach	Binding of acetaldehyde to L-cysteine	4 hours

Secondary Outcomes

Measure	Description	Time Frame
4-methyltiazolidine-2-carboxylic acid concentration in the stomach	Production of inert 4-methyltiazolidine-2-carboxylic acid after binding to L-cysteine	4 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Per M Hellstrom, MD, PhD	Uppsala University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uppsala University		Uppsala	Uppsala County	75185	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

World J Gastroenterol

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005757	Gastritis, Atrophic

Ancestor Terms

ID	Term
D005756	Gastritis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

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