ERME Study
Research type
Research Study
Full title
PILOT STUDY TO ASSESS THE EFFECT OF ENZYME RICH MALT EXTRACT IN TREATMENT OF IRRITABLE BOWEL SYNDROME (IBS)
IRAS ID
272652
Contact name
Stephen Bain
Contact email
Sponsor organisation
Ateria Health Limited
ISRCTN Number
14173715
Duration of Study in the UK
0 years, 8 months, 27 days
Research summary
Research Summary
This study is designed to investigate an innovative approach to the treatment of IBS, a very common chronic gastro-intestinal complaint. Preliminary studies suggest that administration of digestive enzymes to reduce the amount of food residue passing into the colon for fermentation, may prove highly effective.Patients with IBS will be randomised in a double-blind fashion to receive a six week course of either the enzyme-rich malt extract, used for many years in baking and cookery, 15 mls twice daily, or a similarly flavoured placebo in which the enzymes have been destroyed by heating.
Patient response will be monitored using a validated symptoms/quality of life questionnaire. Urine samples will be collected at the start and end of treatment and frozen at -80’C until analysed at at National Mass Spectrometry Facility, Swansea University Medical School, Swansea SA2 8PP to determine changes in fermentation products.
Summary of Results
Irritable Bowel Syndrome (IBS) is a common gastrointestinal complaint. This study was designed to investigate whether oral dosing with an enzyme rich malt extract could benefit patients who had IBS.The study involved some clinical assessments to confirm patients were suitable to enter the study, questionnaires, clinic visits and telephone conversations during the course of the 8 week study.
The study planned to recruit 50 subjects in whom there was confirmed evidence of IBS. This two armed study planned to randomise patients to either active ERME or match Placebo (inert solution that looked identical to the active product). Subjects were screened initially by telephone to confirm they met the entry criteria then invited to the Joint Clinical Research Unit at ILS 2 (Swansea Bay University Health Board).Following consent patients completed additional questionnaires
and were randomised to one of the arms of the study. They were instructed to take 15mls of the product twice daily prior to food for 6 weeks. Participants were followed up by phone at week 2 and week 4 to confirm compliance and check for any adverse effects with a final follow up call at 8 weeks.
Recruitment commenced in April 2020 and 6 subjects were initially recruited by December 2020.
Only 3 of the subjects completed the study, one subject was lost to follow-up at week 2, and the other two stopped the intervention - one subject complained of heartburn and nausea and the other nausea and stomach cramps and both withdrew from the study.Of the three completing subjects, one subject was delighted and at the 8 week telephone call had no IBS symptoms, the other two subjects were well.
Unfortunately the unforeseen global COVID-19 pandemic and enforced government restrictions including closing of routine patient clinics we halted recruitment immediately in January 2021 to ensure patient safety was not compromised. Now that most restrictions have been lifted the Gastrointestinal Clinics which we targeted for patient recruitment are still prioritising urgent suspected cancer patients and these patients are not yet being reviewed. During this long delay the Sponsor has now marketed the product as a food supplement.
As it is not currently feasible to identify these patients the study team and sponsor decided that the study should now be terminated.REC name
Wales REC 2
REC reference
19/WA/0320
Date of REC Opinion
19 Dec 2019
REC opinion
Further Information Favourable Opinion