Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Not applicable
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
Not applicable
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