Behavioural Treatment for Functional Bowel Symptoms in Inflammatory Bowel Disease

NCT ID: NCT03177044

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2021-12-31

Brief Summary

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..

Detailed 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.

Conditions

Inflammatory Bowel Diseases; Functional Gastrointestinal Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioural treatment

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

Group Type: EXPERIMENTAL

Behavioural treatment

Intervention Type: BEHAVIORAL

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

Interventions

Behavioural treatment

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Behavioural training programme

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St Vincent's Hospital Melbourne

OTHER

Sponsor Role: lead

Responsible Party

Angela Khera

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael A Kamm, MBBS PhD

Role: STUDY_DIRECTOR

St Vincent's Hospital Melbourne

Locations

St Vincent's Hospital

Fitzroy, Victoria, Australia

Countries

Australia

Other Identifiers

HREC/17/SVHM/92

Identifier Type: -

Identifier Source: org_study_id