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Effect of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Imperial College London.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149149
First Posted: September 8, 2005
Last Update Posted: July 17, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wexham GI Trust
Information provided by:
Imperial College London
  Purpose
Zinc carnosine is a food supplement which is available in the health food shops. The investigators wish to see if it can reduce intestinal swelling in people who take non-steroidal anti-inflammatory (anti-swelling) drugs (NSAIDs).

Condition Intervention Phase
Healthy Drug: Zinc carnosine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Use of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers Taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Effect of zinc carnosine in reducing the gut damage caused by non-steroidal anti-inflammatory drugs

Secondary Outcome Measures:
  • Differences in dyspepsia score
  • Differences in faecal calprotectin

Estimated Enrollment: 12
Study Start Date: May 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18-35 years

Exclusion Criteria:

  • Conditions known to alter intestinal permeability, eg previous bowel surgery, celiac disease
  • Conditions where NSAIDs are contraindicated, eg asthma, renal failure, heart failure
  • Diabetes
  • Any other serious illness
  Contacts and Locations
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): NCT00149149


Contacts
Contact: Asif Mahmood, MD 02083838067 asif.mahmood@imperial.ac.uk

Locations
United Kingdom
Imperial College Recruiting
London, United Kingdom, W12 0NN
Contact: Asif Mahmood, MD    02083838067    asif.mahmood@imperial.ac.uk   
Sub-Investigator: Asif Mahmood, MRCP         
Principal Investigator: Raymond Playford, FRCP, PhD         
Sponsors and Collaborators
Imperial College London
Wexham GI Trust
Investigators
Principal Investigator: Raymond Playford, MD, PhD Imperial College London
  More Information

ClinicalTrials.gov Identifier: NCT00149149     History of Changes
Other Study ID Numbers: 05/Q0408/19
First Submitted: September 7, 2005
First Posted: September 8, 2005
Last Update Posted: July 17, 2007
Last Verified: September 2005

Keywords provided by Imperial College London:
Reduction in NSAID related gut damage

Additional relevant MeSH terms:
Zinc
Anti-Inflammatory Agents, Non-Steroidal
Polaprezinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents