The Multi-disciplinary Treatment of Functional Gut Disorders Study (MANTRA)

St Vincent's Hospital Melbourne

Status: Completed

Conditions: Other Rome IV Functional Gastrointestinal Disorders; Faecal Incontinence; Irritable Bowel Syndrome; Functional Dyspepsia; Constipation - Functional; Functional Abdominal Pain Syndrome

Treatments: Other: Multi-disciplinary clinic model; Other: Standard outpatient care

Study type: Interventional

Funder types: Other

Identifiers

NCT03078634

MANTRA

Details and patient eligibility

About

Randomised controlled trial comparing standard outpatient clinic treatment with multi-disciplinary clinic treatment for functional gastrointestinal disorders. Patients will be followed up to end of clinic treatment and 12 months beyond the end of treatment. Symptoms, quality of life, costs to the healthcare system and psychological outcomes will be assessed.

Enrollment: 188 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Functional gastrointestinal disorder as defined by Rome IV

Exclusion criteria

• Diagnosed or suspicion of organic gastrointestinal disorder (ie Coeliac, IBD)
• Age <18 or >80
• Non-English speaking
• Patient's from outside of metropolitan Melbourne who cannot attend clinic visits
• Prominent eating disorder
• Chronic opioid dependence
• Medications which can explain functional gut symptoms
• Surgery of GI tract that can explain functional gut symptoms
• Major, non-GI, organ dysfunction
• Pregnancy
• Major Psychiatric disorder

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups, including a placebo group

Multi-Disciplinary clinic

Active Comparator group

Treatment:

Other: Multi-disciplinary clinic model

Standard Gastrointestinal clinic

Placebo Comparator group

Treatment:

Other: Standard outpatient care