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Effect of Zinc Carnosine on Intestinal Permeability in Healthy Volunteers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Wexham GI Trust
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00149149
First received: September 7, 2005
Last updated: July 16, 2007
Last verified: September 2005
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00149149     History of Changes
Other Study ID Numbers: 05/Q0408/19
Study First Received: September 7, 2005
Last Updated: July 16, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on May 22, 2013