Irritable bowel syndrome Digestive System Irritable bowel syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients presenting to the GP with IBS-like symptoms characterised by intermittent or constant loose stool
Exclusion criteria
Exclusion criteria: 1. Unexplained weight loss, rectal bleeding, fever, anaemia, palpable mass or sudden unexplained onset of symptoms 2. Previous referral for chronic GI symptoms to a gastroenterologist or GI surgeon 3. Previous cholecystectomy 4. Previous gastrointestinal surgery of any type except appendicectomy, abdominal wall or femoral hernia repair or diagnostic laparoscopy without surgical intervention 5. Past history of inflammatory bowel disease, coeliac disease, chronic liver or pancreatic disease 6. Past history of cancer (except basal cell carcinoma) 7. Consultation with any health professional in the last 5 years for abnormal GI symptoms 8. Previous investigations in secondary care for IBS-like symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IBS symptoms measured using the IBSSSS questionnaire at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Economic evaluation of healthcare and patient costs at 1 year: 1.1. NHS costs calculated from electronic patient records for the year that the patient is included in the study 1.2. Patient costs related to their IBS-like issues calculated with a monthly economic evaluation filled in by the patient for the year they are in the study 1.3. QALYs assessed using EQ5DL at 1 year 2. Quality of life measured using Modified GSRS, IBSSSS, SF12, EQ5D3l at 1 year 3. Time to symptom improvement measured using patient records at 1 year 4. Conditions diagnosed measured using patient records at any time from randomisation to end of 1-year follow-up | — |
Countries
England, United Kingdom