Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/02/2015
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 S Pathmakanthan

ORCID ID

Contact details

GI Medicine
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265122367

Study information

Scientific title

Bacterial supplementation as treatment for the irritable bowel syndrome: a randomised double-blind placebo-controlled study

Acronym

Study hypothesis

To assess the tolerance and efficacy of Synbiotic Cocktail 2000 in symptom reduction in the irritable bowel syndrome.

Ethics approval

Not provided at time of registration

Study design

Double-blind randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Digestive System: Irritable bowel syndrome (IBS)

Intervention

ASSESSMENT ON ADMISSION INTO TRIAL: History and examination, normal blood tests and a previously normal flexible sigmoidoscopy.

ASSESSMENT DURING STUDY PERIOD: All patients will be randomised to receive either the placebo or Synbiotic cocktail 2000 daily for 8 weeks. Prior to this period, there will be a run in period of 2 weeks where patients will record baseline gastrointestinal symptoms on a weekly basis as well as bowel frequency and consistency on a daily basis. A previously validated patient diary will be used scoring abdominal pain, bloating, number and consistency of stool and level of flatulence completed on a weekly basis. After the 2 week run in period, a study period involving Synbiotic or placebo intake will last for 8 weeks. A final questionnaire would be sent out to all patients 6 months post study period, using the same format. Prior to commencement and directly after treatment or placebo period, patients will undergo a hydrogen breath test to ensure bacterial supplementation has not resulted in bacterial overgrowth.

REMOVAL FROM STUDY: Patients may be removed from the study if one or more of the following occurs: Protocol violation or non-compliance on part of the patient, refusal of the patient to continue treatment and a decision by the investigator that termination is in the patient's best medical interest (or a significant unrelated medical illness or complication).

Intervention type

Drug

Phase

Not Specified

Drug names

Synbiotic Cocktail 2000

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

13/04/2003

Overall trial end date

13/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Any patient seen in gastroenterology outpatient clinics at University Hospital Birmingham who fulfils the Rome criteria II for IBS would be offered entry into the trial
2. Patients without a history of malabsorption, previous abdominal surgery, diverticulitis or other organic intestinal disease

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

100 patients (50 in each arm).

Participant exclusion criteria

1. Pregnancy
2. Any form of mental disorder
3. Severe systemic illness

Recruitment start date

13/04/2003

Recruitment end date

13/04/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

GI Medicine
Birmingham
B29 6JD
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

University Hospital Birmingham NHS Trust (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

Publication citations

Additional files

Editorial Notes