Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease (LIBERATE)

St Vincent's Hospital Melbourne

Status: Completed

Conditions: Functional Gastrointestinal Disorders; Inflammatory Bowel Diseases

Treatments: Behavioral: Behavioural treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03177044

HREC/17/SVHM/92

Details and patient eligibility

About

The primary aim of the project is to investigate whether a behavioural training programme improves troublesome bowel symptoms, that people with inflammatory bowel disease continue to have, despite their disease being controlled by medication. The other aim is to determine if there are factors which influence how well the training programme works.

People attending an Inflammatory Bowel Disease clinic in a tertiary hospital, with bothersome bowel symptoms despite disease control, will be asked to join the study. This involves 2 to 6 sessions with a pelvic floor trained physiotherapist over a period of 6 months with further follow up at 12 months..

Full description

Inflammatory bowel diseases, chiefly Crohn's disease and ulcerative colitis, are chronic gastrointestinal (gut) conditions which tend to flare up some times and be quiet for other periods of time. They are usually controlled by medication. Inflammatory bowel disease is becoming more common, is usually diagnosed at a young age and is lifelong.

A significant number of people with inflammatory bowel disease can have bowel symptoms which are bothersome even when the disease is quiescent. These symptoms include bowel urgency, frequent toileting, incontinence (leakage), constipation (infrequent bowel actions and/or difficulty emptying the bowel), abdominal pain, rectal pain or abdominal bloating. The symptoms can be very embarrassing or stressful, limiting activities and making life less enjoyable.

People with these bowel symptoms, but without inflammatory bowel disease, respond to a type of therapy called behavioural treatment. We don't know yet if this treatment helps people with inflammatory bowel disease.

Behavioural treatment involves learning about how the bowel works, better ways to manage bowel problems and specific exercises to improve bowel control. Specially trained pelvic floor physiotherapists provide 2-6 sessions, over 6 months, of behavioural treatment which may include the use of biofeedback techniques.

Participants will be asked to complete surveys at the beginning and end of treatment and 12 months later.

There are no recognised risks or unwanted side effects caused by behavioural treatment. The benefits are that people with inflammatory bowel disease will have an alternative low cost, low risk treatment which enables them to self-manage bowel symptoms and improve the quality of their life long term.

Enrollment: 35 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Behavioural treatment

Experimental group

Description:

2 to 6 sessions of bowel behavioural training with a pelvic floor physiotherapist

Treatment:

Behavioral: Behavioural treatment