Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon Lal

ORCID ID

Contact details

Gastroenterology
Clinical Sciences Building
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0217101260

Study information

Scientific title

Nutrient modulation of sensory responses of the human oesophagus

Acronym

Study hypothesis

To determine whether intragastric or intraduodenal infusion of cholecystokinin (CCK)-releasing fatty acid (C12 or C14) modifies the threshold at which sensations are experienced in response to different oesophageal stimuli, when compared to a non-CCK-releasing fatty acid (C10 or C8).

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Sensory responses of the human oesophagus

Intervention

Extended pilot study consisting of a series of randomised controlled studies.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To confirm or refute the hypothesis that fatty acids have a differential effect on oesophageal sensations.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2001

Overall trial end date

31/05/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy male or female volunteers aged 20 - 60 years.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/06/2001

Recruitment end date

31/05/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gastroenterology
Salford
M6 8HD
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Salford Royal Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes