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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03177044




Registration number
NCT03177044
Ethics application status
Date submitted
1/06/2017
Date registered
6/06/2017

Titles & IDs
Public title
Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease
Scientific title
Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease
Secondary ID [1] 0 0
HREC/17/SVHM/92
Universal Trial Number (UTN)
Trial acronym
LIBERATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Diseases 0 0
Functional Gastrointestinal Disorders 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Behavioural treatment

Experimental: Behavioural treatment - 2 to 6 sessions of bowel behavioural training with a pelvic floor physiotherapist


BEHAVIORAL: Behavioural treatment
2 to 6 sessions of behavioural training with a pelvic floor physiotherapist
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient rating of improvement in symptoms
Timepoint [1] 0 0
At study completion, up to 12 weeks
Secondary outcome [1] 0 0
Change in Personal assessment of Constipation Symptoms (PAC-SYM) score
Timepoint [1] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [2] 0 0
Change in St Marks Faecal Incontinence Score
Timepoint [2] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [3] 0 0
Change in Inflammatory Bowel disease questionnaire (IBDQ) score
Timepoint [3] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [4] 0 0
Change in Short Form -36 (SF-36) score
Timepoint [4] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [5] 0 0
Change in Hospital Anxiety and Depression Score (HADS)
Timepoint [5] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [6] 0 0
Change in Brief Illness Perception Questionnaire score
Timepoint [6] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [7] 0 0
Change in Brief Cope score
Timepoint [7] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [8] 0 0
Change in Inflammatory Bowel Disease Self-efficacy scale (IBD-SES)
Timepoint [8] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year
Secondary outcome [9] 0 0
Change in Euro-Qol (EQ-5D)
Timepoint [9] 0 0
From baseline to study completion (up to 12 weeks) and at 1 year

Eligibility
Key inclusion criteria
* Proven history of inflammatory bowel disease
* Clinical evidence of mild, stable disease or remission
* Mayo score = 4, Harvey Bradshaw index = 7
* Bothersome lower bowel symptoms of any of the following: frequency, urgency, incontinence, difficult evacuation, constipation
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Significant medical or psychiatric comorbidity that in the opinion of the investigators would interfere with bowel function or adherence to the protocol
* Clinically significant narcotic or substance abuse that in the opinion of the investigators would interfere with bowel function or adherence to the protocol
* Recognised eating disorder
* Non- English speaking or illiterate
* Pregnancy
* Previous pelvic floor physiotherapy
* Current participant in another trial

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2021
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael A Kamm, MBBS PhD
Address 0 0
St Vincent's Hospital Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03177044