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

ISRCTN ISRCTN67764449
DOI https://doi.org/10.1186/ISRCTN67764449
Secondary identifying numbers N/A
Submission date
13/12/2005
Registration date
15/12/2005
Last edited
22/04/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised double-blind placebo-controlled cross-over study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesH1: 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) studiedIrritable Bowel Syndrome (IBS)
InterventionTreatment by nucleotide supplements for 8 weeks and placebo for 8 weeks
Intervention typeOther
Primary outcome measureImprovement in daily ratings of seven symptoms of IBS (self report) above placebo level.
Secondary outcome measuresImprovement in anxiety and depression ratings (self report) following experimental condition.
Overall study start date01/10/2004
Completion date30/09/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40
Key inclusion criteriaParticipants should be aged 18–65, should have been diagnosed as having IBS by a qualified medical practitioner, and should have diarrhoea as a main symptom.
Key exclusion criteriaAny other co-existing illnesses, and non-confirmation of the diagnosis by GP.
Date of first enrolment01/10/2004
Date of final enrolment30/09/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of East London
London
E15 4LZ
United Kingdom

Sponsor information

University of East London (UK)
University/education

School of Psychology
Romford Road
London
E15 4LZ
England
United Kingdom

Phone +44 (0)208 223 4461
Email E.A.Attree@uel.ac.uk
ROR logo "ROR" https://ror.org/057jrqr44

Funders

Funder type

Industry

Wyreside Products Limited

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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