Treating people with IBS: a randomised double-blind placebo controlled trial of IntestAidIB in people with Irritable Bowel Syndrome (IBS)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Christine Dancey
Scientific

University of East London
School of Psychology
Romford Road
London
E15 4LZ
United Kingdom

Phone	+44 (0)208 223 4497
Email	C.P.Dancey@uel.ac.uk

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled cross-over study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	H1: treatment with a nucleotide supplement will significantly improve symptoms of irritable bowel syndrome when compared to placebo H2: psychological measures (depression; anxiety) will predict improvement in symptomatology H3: improvements in symptoms will be accompanied by improvements in psychological state, e.g. anxiety and depression
Ethics approval(s)	Approved by the University of East London ethics committee.
Health condition(s) or problem(s) studied	Irritable Bowel Syndrome (IBS)
Intervention	Treatment by nucleotide supplements for 8 weeks and placebo for 8 weeks
Intervention type	Other
Primary outcome measure(s)	Improvement in daily ratings of seven symptoms of IBS (self report) above placebo level.
Key secondary outcome measure(s)	Improvement in anxiety and depression ratings (self report) following experimental condition.
Completion date	30/09/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	Participants should be aged 1865, should have been diagnosed as having IBS by a qualified medical practitioner, and should have diarrhoea as a main symptom.
Key exclusion criteria	Any other co-existing illnesses, and non-confirmation of the diagnosis by GP.
Date of first enrolment	01/10/2004
Date of final enrolment	30/09/2005

University of East London

London
E15 4LZ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	08/06/2006		Yes	No