Contact information
Type
Scientific
Primary contact
Prof Christine Dancey
ORCID ID
Contact details
University of East London
School of Psychology
Romford Road
London
E15 4LZ
United Kingdom
+44 (0)208 223 4497
C.P.Dancey@uel.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Approved by the University of East London ethics committee.
Study design
Randomised double-blind placebo-controlled cross-over study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Irritable Bowel Syndrome (IBS)
Intervention
Treatment by nucleotide supplements for 8 weeks and placebo for 8 weeks
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Improvement in daily ratings of seven symptoms of IBS (self report) above placebo level.
Secondary outcome measures
Improvement in anxiety and depression ratings (self report) following experimental condition.
Overall trial start date
01/10/2004
Overall trial end date
30/09/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
Any other co-existing illnesses, and non-confirmation of the diagnosis by GP.
Recruitment start date
01/10/2004
Recruitment end date
30/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of East London
London
E15 4LZ
United Kingdom
Sponsor information
Organisation
University of East London (UK)
Sponsor details
School of Psychology
Romford Road
London
E15 4LZ
United Kingdom
+44 (0)208 223 4461
E.A.Attree@uel.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Wyreside Products Limited
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/16762076
Publication citations
-
Results
Dancey CP, Attree EA, Brown KF, Nucleotide supplementation: a randomised double-blind placebo controlled trial of IntestAidIB in people with Irritable Bowel Syndrome [ISRCTN67764449]., Nutr J, 2006, 5, 16, doi: 10.1186/1475-2891-5-16.