Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000377831
Ethics application status
Not yet submitted
Date submitted
26/03/2012
Date registered
3/04/2012
Date last updated
3/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Role of probiotics in improving post-colonoscopy symptoms and earlier return of normal bowel function
Scientific title
Role of oral probiotics in improving post-colonoscopy symptoms and earlier return of normal bowel function in patients undergoing colonoscopy after full mechanical bowel preparation
Secondary ID [1] 280223 0
Nil
Universal Trial Number (UTN)
U1111-1129-5014
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptoms after colonoscopy (abdominal pain) 286170 0
Time taken for bowel function to return to normal after colonoscopy 286190 0
Condition category
Condition code
Oral and Gastrointestinal 286364 286364 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High Potency Probiotic Capsules containing Lactobacillus acidophilus NCFM and Bifidobacterium animalis subsp. lactis Bi-07, once daily for 7 days post-colonoscopy
Intervention code [1] 284554 0
Treatment: Other
Comparator / control treatment
Placebo- capsules identical in appearance but without active ingredients
Control group
Placebo

Outcomes
Primary outcome [1] 286821 0
Return to normal bowel function- determined by the patient according to a patient diary
Timepoint [1] 286821 0
24 hours post-colonoscopy, and then daily for up to 2 weeks
Secondary outcome [1] 296733 0
Abdominal pain as assessed by patient questionnaire (100mm visual analogue scale ranging from 'no pain' to 'pain as bad as it could be')
Timepoint [1] 296733 0
Baseline, 2 hours and 24 hours post-colonoscopy

Eligibility
Key inclusion criteria
A patient who has completed full mechanical bowel preparation for a colonoscopy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Failure to complete full mechanical bowel preparation
Enema preparation only for a flexible sigmoidoscopy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation and identical presentation of the probiotic and placebo
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284978 0
Commercial sector/Industry
Name [1] 284978 0
Health World Limited
Country [1] 284978 0
Australia
Funding source category [2] 284979 0
Self funded/Unfunded
Name [2] 284979 0
Dr Timothy Slack
Country [2] 284979 0
Australia
Primary sponsor type
Individual
Name
Dr Timothy Slack
Address
Prince of Wales Hospital
Barker St
RANDWICK NSW 2031
Country
Australia
Secondary sponsor category [1] 283843 0
Individual
Name [1] 283843 0
Dr Francis Lam
Address [1] 283843 0
Sydney Colorectal Associates
Level 7
Prince of Wales Private Hospital
Barker St
RANDWICK NSW 2031
Country [1] 283843 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286982 0
Bellberry
Ethics committee address [1] 286982 0
229 Greenhill Road
Dulwich
South Australia 5065
Ethics committee country [1] 286982 0
Australia
Date submitted for ethics approval [1] 286982 0
01/04/2012
Approval date [1] 286982 0
Ethics approval number [1] 286982 0
2012-03-709

Summary
Brief summary
Mechanical bowel preparation causes a marked imbalance in the colonic microflora. This altered microflora may play a significant role in post-preparation symptoms and delay in return of the normal bowel function for that patient.

AIM
Evaluate the benefit of probiotic use, and associated restoration of the balance of intestinal microflora, for patients undergoing colonoscopy after mechanical bowel preparation.

METHODS
Prospective double-blinded randomised control trial.
Use of probiotics vs placebo in the setting of patients who have undergone full mechanical bowel preparation and colonoscopy
A commercially available probiotic or placebo at recommended daily dose for 7 days after the procedure

END POINTS
Evaluation of post-colonoscopy symptoms
- Abdominal pain
- Time taken for patient bowel function to return to normal (the usual bowel habit for them)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33981 0
Address 33981 0
Country 33981 0
Phone 33981 0
Fax 33981 0
Email 33981 0
Contact person for public queries
Name 17228 0
Dr Timothy Slack
Address 17228 0
Prince of Wales Public Hospital
Barker St
RANDWICK NSW 2031
Country 17228 0
Australia
Phone 17228 0
+61 (0)2 9382 2222
Fax 17228 0
Email 17228 0
[email protected]
Contact person for scientific queries
Name 8156 0
Dr Timothy Slack
Address 8156 0
Prince of Wales Public Hospital
Barker St
RANDWICK NSW 2031
Country 8156 0
Australia
Phone 8156 0
+61 (0)2 9382 2222
Fax 8156 0
Email 8156 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.