Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
06/01/2009
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

Dr Stephen Lewis

ORCID ID

Contact details

Box No 201A
Department of Gastroenterology
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
+44 (0)7669 008 863

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544103828

Study information

Scientific title

Acronym

Study hypothesis

The purpose of this study is to see if the incidence of antibiotic related diarrhoea in elderly patients can be reduced by increasing colonic bifidobacteria concentrations with the concomitant prescription of oligofructose. Patients for the study will be identified by asking the Medical and Department for the Elderly teams if they had admitted any suitable patients. A brief clinical and drug history would be taken.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Digestive System: Diarrhoea

Intervention

The volunteers would then be randomly allocated to one of two groups.

Group A will take a placebo (10 g/day of sucrose powder) or group B 10 g/day of oligofructose. The trial powders will be administered by the ward nursing staff along with the volunteers' normal medication. Volunteers will take the trial powders for the length of time they are taking antibiotics and for a further 7 days after stopping antibiotics. Volunteers will be assessed continuously by recording on a stool form using a four point scale (1 hard, 2 lumpy, 3 mushy and 4 loose) and interdefecatory intervals. Both give an indication of intestinal transit rate. Recordings will be done by the patient or nursing staff as appropriate. The volunteers will be followed up for 7 days after stopping the oligofructose or placebo. The volunteer will have further stool samples sent to be analysed for the presence of Clostridium difficile toxin if they develop diarrhoea during the study. The study's end point is the occurrence of diarrhoea due to Clostridium difficile.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

16/06/2000

Overall trial end date

15/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

250 volunteers >65 years old.

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

250

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

16/06/2000

Recruitment end date

15/06/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box No 201A
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Cambridge Consortium - Addenbrooke's (UK)

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15709999

Publication citations

  1. Results

    Lewis S, Burmeister S, Cohen S, Brazier J, Awasthi A, Failure of dietary oligofructose to prevent antibiotic-associated diarrhoea., Aliment. Pharmacol. Ther., 2005, 21, 4, 469-477, doi: 10.1111/j.1365-2036.2005.02304.x.

Additional files

Editorial Notes