Novel management of symptoms in patients with irritable bowel syndrome

Plain English Summary

Background and study aims
Irritable bowel syndrome (IBS) affects up to 1 in 5 people in Britain. IBS can have a huge impact on a sufferer’s daily activities, general wellbeing and overall health. IBS often carries major financial implications because of time lost from work, the cost of attending GP appointments and prescriptions. Sufferers also often report substantial extra ongoing costs for things like over-the-counter medicines, incontinence pads, deodorants, extra lavatory paper and laundry. IBS does not just affect sufferers, their work, family and friendships. Treating IBS costs the NHS much more than £100 million annually.
The National Institute for Health and Care Excellence (NICE) guides how tests and treatments for diseases should be used. For IBS they recommend that the diagnosis can be made if someone has typical symptoms and normal results from four blood tests. More detailed tests used by specialists, NICE says, are not needed. Once IBS is diagnosed, NICE recommends lifestyle and dietary changes and/or medicines although they admit that the evidence that these things help is weak. Indeed, NICE acknowledges that when their recommended treatments are used, at least half of sufferers continue with long term troublesome symptoms. The problem is that “typical IBS symptoms” and four blood tests are an unreliable way to distinguish patients with true IBS from those with other conditions which cause symptoms similar to IBS. Evidence suggests that most people with constant or intermittent diarrhoea diagnosed as IBS, in fact, have a different diagnosis which the NICE recommended tests do not pick up. Examples of very treatable, often missed diagnoses and the number of affected people include:
1. Sensitivity to fat in diet: 1 in 4 patients
2. Abnormal digestion of sugars: 1 in 4
3. Germs living in parts of the bowel where there should be no germs: 1 in 4
4. Microscopic bowel inflammation: 1 in 10
5. Pancreas gland working inadequately: 1 in 20
The aim of this study is to measure the benefit for the patient of care delivered by a GP following NICE recommendations compared to care given by a specially trained nurse.

Who can participate?
Patients who the GP considers are likely to have IBS, have not been previously investigated for this and have intermittent or constant diarrhoea

What does the study involve?
If patients agree to take part in this study, they will be assigned to one of two groups at random. The results from each group will be compared at the end of the trial. Neither the patient, doctor nor nurse can choose to which group any patient are allocated. Half the people taking part in our study will be allocated to care delivered by the GP following NICE recommendations for the treatment of IBS-like symptoms and half by a specially trained nurse who will organise some additional tests. The nurse will arrange a simple series of tests focusing on identifying whether the treatable conditions listed above are present and offering specific treatments based on the test results. The researchers will measure which group improves the most and the cost for the patients and the NHS of this approach. They will follow the patients for a year to see whether any improvement achieved continues long term.

What are the possible benefits and risks of participating?
The main disadvantage for everyone taking part is the extra time required to fill out the questionnaires on two occasions and keep a diary of the cost of having these symptoms and all the attendance for tests and appointments. There will also be extra time required for the tests performed for those who are allocated to the group where care is provided by the nurse. It is not known whether it is better to do these tests, and so they may prove not to be helpful. None of the tests the nurse might arrange are unusual or experimental, however, they are generally not offered to people with IBS. They are all standard tests used frequently in other conditions. There is no risk involved with filling out questionnaires, providing breath samples or stool samples. Minor pain and bruising can occur with blood sampling. The nuclear medicine scan to detect a sensitivity to the amount of fat in the diet is a two-part test. On the first visit to the department participants will be asked to swallow a capsule which contains an artificial bile acid which is linked to a very small amount of radioactivity. The amount of radioactivity is equivalent to about the same amount that people are exposed to in their daily lives over a 1- to 2-month period. After they have swallowed this capsule, participants will be asked to wait for about 3 hours. Then they have a scan using a special camera to measure the tiny amount of radioactivity in their body - this takes about 15 minutes. Afterwards, they will be free to go but will be asked to return after 1 week when the scan will be performed a second time. The difference between the amount of measured radiation between the first and the second scan will show whether they have bile acid malabsorption, a condition which often mimics IBS, and what sort of treatment is likely to help them most of all. The amount of radioactivity in the capsule is so little that participants do not need to avoid any activity or being with people while the test is taking place. However, the test should not be performed on anyone who is or could be pregnant in the next 3 months. Potential risks from the telescope examination (flexible sigmoidoscopy) include heavy bleeding or tearing of the bowel wall. These problems occur in fewer than 1 in 10,000 people, and are detailed in the standard information booklet on flexible sigmoidoscopy which will be provided in advance.

Where is the study run from?
Lincolnshire Community Health Services Trust (UK)

When is the study starting and how long is it expected to run for?
May 2020 to April 2023

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Team.research@nhs.net

Trial website

Type

Public

Primary contact

Prof Jervoise Andreyev

ORCID ID

http://orcid.org/0000-0002-7165-6352

Contact details

Lincoln County Hospital
Lincoln
LN2 5QY
United Kingdom
+44 (0)1522 707473
Jervoise.Andreyev@ULH.nhs.uk

EudraCT number

2020-003531-24

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 44804, IRAS 276667

Scientific title

Organic disease masquerading as irritable bowel syndrome: a randomized controlled trial in primary care: the Lincolnshire POACHER study (Promoting Optimal Assessment to Change Health and Engineer an Economic Revolution)

Acronym

POACHER

Study hypothesis

The majority of patients with irritable bowel syndrome (IBS)-like symptoms characterised by diarrhoea, have missed organic pathology.

Ethics approval

Approved 30/06/2020, West of Scotland Ethics Committee 4 (Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, UK; +44 (0)141 314 0213; WoSREC4@ggc.scot.nhs.uk), REC ref: 20/WS/0029

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

See additional files

Condition

Irritable bowel syndrome

Intervention

Randomisation will be performed independently by the Hull Health Trials Unit:
Arm 1: Controls: standard GP treatment following NICE guidance for the treatment of IBS-like symptoms.
Arm 2: Intervention arm: experimental investigations and treatments, nurse-led treatment following checklists and arranging additional investigations.

The patients will be followed for 1 year following randomisation.

Treatment will be given as necessary in both arms. The primary endpoint will be improvement in symptoms at 1 year.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

IBS symptoms measured using the IBSSSS questionnaire at 1 year

Secondary outcome measures

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

Overall trial start date

01/09/2019

Overall trial end date

30/04/2023

Reason abandoned (if study stopped)

Participant inclusion criteria

Patients presenting to the GP with IBS-like symptoms characterised by intermittent or constant loose stool

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

134

Participant 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

Recruitment start date

01/09/2020

Recruitment end date

30/04/2022

Countries of recruitment

United Kingdom

Trial participating centre

Lincolnshire Community Health Services NHS Trust
Beech House Witham Park Waterside
Lincoln
LN5 7JH
United Kingdom

Organisation

Lincolnshire Community Health Services NHS Trust

Sponsor details

Beech House
Witham Park
Waterside South
Lincoln
LN5 7JH
United Kingdom
+44 (0)1522 308808
debbie.jeffrey@nhs.net

Sponsor type

Hospital/treatment centre

Website

https://www.lincolnshirecommunityhealthservices.nhs.uk

Funder type

Government

Funder name

Research for Patient Benefit Programme

Alternative name(s)

NIHR Research for Patient Benefit Programme, RfPB

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Publication and dissemination plan

The outcome of this study will be published in peer-review journals and will be presented at conferences attended by primary care physicians and nurses, public health professionals and gastroenterologists. It will be widely disseminated to IBS support groups. The researchers will develop a trial website and use social media to help ensure the widest possible publicity for their findings.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a repository.

Intention to publish date

31/12/2023

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

• ISRCTN87945798_PIS_V2_ 10Mar20.docx Uploaded 14/07/2020
• ISRCTN87945798_PROTOCOL_V1_21Jan20.docx Uploaded 14/07/2020

14/07/2020: The participant information sheet has been uploaded. Uploaded protocol Version 1, 21 January 2020 (not peer reviewed). 10/02/2020: Trial's existence confirmed by the NIHR.