Condition category
Digestive System
Date applied
13/12/2005
Date assigned
15/12/2005
Last edited
22/04/2008
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

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 18–65, 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

  1. 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.

Additional files

Editorial Notes