NCT00149149

Brief Summary

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: non-steroidal antiinflammatory drug.).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started May 2005

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2006

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

September 7, 2005

Last Update Submit

October 6, 2023

Conditions

Healthy

Keywords

Reduction in NSAID related gut damage

Outcome Measures

Primary Outcomes (2)

  • Lactulose:rhamnose ratio - Arm1 (Urine)

    Lactulose:rhamnose urine ratio in zinc carnosine/indomethacin coadministered patients

    day 5

  • Lactulose:rhamnose ratio - Arm2 (Urine)

    Lactulose:rhamnose urine ratio in placebo/indomethacin coadministered patients

    day 5

Study Arms (2)

Indomethacin treated volunteers

EXPERIMENTAL

5d of indomethacin treatment (50 mg t.i.d) with ZnC (37.5 mg b.i.d) coadministration.

Other: Zinc Carnosine coadministered with Indomethacin

Placebo treated volunteers

PLACEBO COMPARATOR

5 days of indomethacin treatment (50 mg t.i.d) with placebo coadministration.

Other: Placebo coadministered with Indomethacin

Interventions

Zinc Carnosine coadministered with IndomethacinOTHER
Indomethacin treated volunteers
Placebo coadministered with IndomethacinOTHER
Placebo treated volunteers

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-35 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College

London, W12 0NN, United Kingdom

Location

Related Publications (1)

  • Mahmood A, FitzGerald AJ, Marchbank T, Ntatsaki E, Murray D, Ghosh S, Playford RJ. Zinc carnosine, a health food supplement that stabilises small bowel integrity and stimulates gut repair processes. Gut. 2007 Feb;56(2):168-75. doi: 10.1136/gut.2006.099929. Epub 2006 Jun 15.

    PMID: 16777920RESULT

Related Links

MeSH Terms

Interventions

Indomethacin

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Raymond Playford, MD, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Zinc carnosine or placebo for 7 days with 5 days of indomethacin from days 2-7. It was a cross over protocol with 2 week washout inbetween.
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

May 1, 2005

Primary Completion

May 18, 2006

Study Completion

May 18, 2006

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations

GB(1)