Nutrient modulation of sensory responses of the human oesophagus

ISRCTN	ISRCTN82131820
DOI	https://doi.org/10.1186/ISRCTN82131820
Secondary identifying numbers	N0217101260

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Simon Lal
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Nutrient modulation of sensory responses of the human oesophagus
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Sensory responses of the human oesophagus
Intervention	Extended pilot study consisting of a series of randomised controlled studies.
Intervention type	Other
Primary outcome measure	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 study start date	01/06/2001
Completion date	31/05/2004

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	Healthy male or female volunteers aged 20 - 60 years
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/06/2001
Date of final enrolment	31/05/2004

Hope Hospital

Salford
M6 8HD
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Hospital/treatment centre

Salford Royal Hospitals NHS Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

05/02/2018: No publications found, verifying study status with principal investigator.