Effect of enzyme rich malt extract (erme) in treatment of Irritable Bowel Syndrome (IBS)

ISRCTN ISRCTN21365636
DOI https://doi.org/10.1186/ISRCTN21365636
Secondary identifying numbers ERMEinIBS
Submission date
28/11/2017
Registration date
14/12/2017
Last edited
21/05/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Mrs Tracey Dorey
Public

York Teaching Hospital NHS Foundation Trust
Wigginton Road
York
YO31 8HE
United Kingdom

Phone +44 (0)1904 726954
Email tracey.dorey@york.nhs.uk

Study information

Study designSingle-centre double-blind placebo-controlled randomised trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleDouble blind randomised controlled trial comparing the effect of enzyme rich malt extract with placebo in the treatment of irritable bowel syndrome
Study objectivesThere will be a difference in IBS severity score at 6-weeks post randomisation between the two groups.
Ethics approval(s)North of Scotland Research Ethics Service, 17/08/2017, REC ref: 17/NS/0079
Health condition(s) or problem(s) studiedIrritable Bowel Disease
InterventionParticipants 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 typeSupplement
Primary outcome measureIBS severity is measured using the IBS Severity Score Questionnaire at 6 weeks
Secondary outcome measures1. 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 study start date01/04/2017
Completion date31/12/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants110
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment03/01/2018
Date of final enrolment20/06/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

York Teaching Hospital NHS Foundation Trust
Wigginton Road
York
YO31 8HE
United Kingdom

Sponsor information

York Teaching Hospital NHS Foundation Trust
Hospital/treatment centre

Wigginton Road
York
YO31 8HE
England
United Kingdom

ROR logo "ROR" https://ror.org/027e4g787

Funders

Funder type

Industry

Arteria Health Ltd

No information available

Results and Publications

Intention to publish date01/01/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planIt is intended to publish the results whether positive or negative in both abstracts and major gastroenterological journals.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

21/05/2021: Proactive update review. No publications found.
09/08/2018: The recruitment end date was changed from 31/08/2018 to 20/06/2018.