Plain English Summary
Background and study aims
Irritable bowel syndrome (IBS) is a common condition which causes symptoms of abdominal pain, bloating and altered bowel habits. Conventional treatment is frequently unsatisfactory. The cause of IBS is unknown, but it has been suggested that many of the symptoms result from undigested carbohydrates reaching the large bowel (colon). When this happens the gut bacteria living in the large bowel can ferment undigested food, producing chemicals that cause IBS. These chemicals can be detected in both blood and urine. It has been shown that reducing the number of certain carbohydrates in the diet can improve the symptoms of IBS for some patients. The aim of this study is to find out whether giving a food supplement called enzyme rich malt extract (ERME), which contains a high concentration of enzymes that digest carbohydrates, will improve symptoms of IBS. ERME is a by-product of the malting process, in which cereal grains (like barley) are dried, commonly for making beer. It is sweet, palatable and has been used as an ingredient in baking and cookery for many years.
Who can participate?
Patients aged 18-65 with IBS
What does the study involve?
Participants are randomly allocated to take 30 ml of either ERME or an inactive malt product every day for 6 weeks. Participants are followed up by telephone at 2-week intervals until 8 weeks. At week 6 there is a follow-up clinic visit to measure IBS severity using a questionnaire.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
York Teaching Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
April 2017 to December 2018
Who is funding the study?
Arteria Health Ltd
Who is the main contact?
Tracey Dorey
tracey.dorey@york.nhs.uk
Trial website
Contact information
Type
Public
Primary contact
Mrs Tracey Dorey
ORCID ID
Contact details
York Teaching Hospital NHS Foundation Trust
Wigginton Road
York
YO31 8HE
United Kingdom
+44 (0)1904 726954
tracey.dorey@york.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ERMEinIBS
Study information
Scientific title
Double blind randomised controlled trial comparing the effect of enzyme rich malt extract with placebo in the treatment of irritable bowel syndrome
Acronym
Study hypothesis
There will be a difference in IBS severity score at 6-weeks post randomisation between the two groups.
Ethics approval
North of Scotland Research Ethics Service, 17/08/2017, REC ref: 17/NS/0079
Study design
Single-centre double-blind placebo-controlled randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Irritable Bowel Disease
Intervention
Participants will be randomised 1:1 to either ERME (enzyme rich malt extract) or control (heat denatured malt product). Participants will be asked to consume 30 ml per day for 6 weeks. Participants will be followed up at 2-week intervals until 8 weeks. At week 6 the follow-up visit will consist of a clinic visit all others will be over the telephone.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
IBS severity is measured using the IBS Severity Score Questionnaire at 6 weeks
Secondary outcome measures
1. Severity of abdominal pain is measured using IBS Severity Score Questionnaire at baseline, 2,4, 6 and 8 weeks
2. Frequency of abdominal pain is measured using IBS Severity Score Questionnaire at baseline, 2,4, 6 and 8 weeks
3. Abdominal bloating measured using IBS Severity Score Questionnaire at baseline, 2,4, 6 and 8 weeks
4. Bowel habit “satisfaction” is measured using IBS QoL Questionnaire at baseline 2,4, 6 and 8 weeks
5. impact of IBS upon lifestyle is measured using IBS QoL Questionnaire at baseline, 2,4, 6 and 8 weeks
6. Bowel frequency is measured using self-report by participants at baseline and 6 weeks
7. Stool Consistency is measured using Bristol Stool Chart at baseline and 6 weeks
8. Absence from work days related to IBS is measured using IBS Severity score scales at baseline , 2,4, 6 and 8 weeks
9. IBS quality of life is measured using IBS QoL Questionnaire Score at baseline , 2,4, 6 and 8 weeks
Overall trial start date
01/04/2017
Overall trial end date
31/12/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18-65
2. Current symptoms of IBS (abdominal pain and altered bowel habit) ROME IV
3. Prepared to take ERME for duration (taste test available for patient)
4. Normal full blood count within last 12 months (from notes)
5. Normal calprotectin within last 12 months <50 (from notes)
6. Normal tTG (Tissue Transglutaminase) <10 (from notes)
7. Positive for malfermentation (from IBS Questionnaire Score) – decision by CI
8. Registered with a GP and consent to GP being informed
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
110
Participant exclusion criteria
1. Pregnant, planning to become pregnant or lactating
2. Diabetic (or other co-morbidity which the CI considers inappropriate)
3. On a restrictive diet or unwilling or unable to change diet
4. Current medication (e.g. opiates) that may influence bowel symptoms (at discretion of the CI)
5. Antibiotics in the previous 6 weeks
6. Other gastrointestinal disease (e.g. coeliac or Crohn’s disease)
7. Significant gastrointestinal surgery (this will be a clinical decision and any patient who has had a surgical procedure that would change the mechanics of gut function would be excluded)
8. Involved in other gastroenterology research project or other interventional study that would affect results
Recruitment start date
03/01/2018
Recruitment end date
31/08/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
York Teaching Hospital NHS Foundation Trust
Wigginton Road
York
YO31 8HE
United Kingdom
Funders
Funder type
Industry
Funder name
Arteria Health Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
It is intended to publish the results whether positive or negative in both abstracts and major gastroenterological journals.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/01/2020
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary