Condition category
Digestive System
Date applied
28/11/2017
Date assigned
14/12/2017
Last edited
12/12/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Sponsor information

Organisation

York Teaching Hospital NHS Foundation Trust

Sponsor details

Wigginton Road
York
YO31 8HE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes