Juvia being used for irritable bowel syndrome
| ISRCTN | ISRCTN14003582 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14003582 |
| IRAS number | 325736 |
| Secondary identifying numbers | 1168, IRAS 325736, CPMS 55644 |
- Submission date
- 18/04/2023
- Registration date
- 10/05/2023
- Last edited
- 20/06/2024
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
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 study does not involve a medicine. The researchers wish to explore whether giving a food supplement called JUVIA will improve symptoms of IBS. JUVIA is an enzyme-rich malt extract (ERME) that contains a high concentration of enzymes that digest carbohydrates that aim to improve symptoms of IBS. ERME is a by-product of the malting process, in which cereal grains (like barley) are dried. It is sweet and easy to drink and has been used for many years in baking and cookery.
Who can participate?
Patients aged 18 – 65 years with symptoms of IBS
What does the study involve?
The study involves two visits to the research clinic with two telephone calls. Participants provide a urine and stool sample at the start and end of the study. The study duration is 4 weeks and during this time participants take a food supplement (drink i.e. JUVIA) 20 ml twice a day before food.
What are the possible benefits and risks of participating?
Juvia could improve IBS symptoms. There could be slightly looser bowel movements and in the first few days possible worsening of symptoms which should settle quickly.
Where is the study run from?
The Clinical Research Unit, Swansea Bay University Health Board (UK)
When is the study starting and how long is it expected to run for?
October 2022 to October 2024
Who is funding the study?
Ateria Health Ltd (UK)
Who is the main contact?
Kathie Wareham, kathie.wareham@wales.nhs.uk
Contact information
Principal Investigator
Swansea Bay University Health Board
Swansea
SA2 8PP
United Kingdom
| Phone | +44 (0)1792 530819 |
|---|---|
| s.c.bain@swansea.ac.uk |
Study information
| Study design | Open study with a marketed food supplement |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | University/medical school/dental school, Other |
| Study type | Other |
| Participant information sheet | 43510_PIS_02May23.pdf |
| Scientific title | Pilot study to assess the effect of enzyme-rich malt extract (Juvia) in the treatment of irritable bowel syndrome |
| Study acronym | JUVIA |
| Study objectives | This study explores whether the administration of a food supplement called JUVIA improves the symptoms of irritable bowel syndrome (IBS). JUVIA is an enzyme-rich malt extract (ERME) that contains a high concentration of enzymes that digest carbohydrates which alters the composition of large bowel contents. ERME is a by-product of the malting process, in which cereal grains (like barley) are dried, and is sweet and easy to drink. It is not classified as a medicine. |
| Ethics approval(s) | Approved 28/04/2023, Wales REC6, c/o Public Health Wales (Building 1, Jobswell Road, St David’s Park, SA31 3HB, UK; +44 (0)1267 611164; Wales.REC6@Wales.nhs.uk), ref: 23/WA/0120 |
| Health condition(s) or problem(s) studied | Irritable bowel syndrome (IBS) |
| Intervention | Participants will be asked to take two tablespoons of JUVIA (enzyme-rich malt extract) each day for 4 weeks and complete a number of questionnaires and provide samples for biochemical analysis. |
| Intervention type | Supplement |
| Primary outcome measure | IBS severity measured using IBS severity score questionnaire from baseline (visit 1) to 4 weeks (visit 2) |
| Secondary outcome measures | Measured at baseline, 2 and 4 weeks: 1. Severity of abdominal pain measured using IBS patient severity score questionnaire 2. Frequency of abdominal pain measured using IBS patient severity score questionnaire 3. Change in abdominal bloating measured using IBS patient severity score questionnaire 4. Change in bowel habit “satisfaction” measured using IBS patient severity score questionnaire 5. Change in the impact of IBS on lifestyle measured using IBS-OOL questionnaire – validated 6. Change in bowel frequency measured using IBS severity score 7. Change in stool consistency measured using IBS severity score 8. Change in absence from work days related to IBS (as defined by IBS severity score scales) measured using IBS severity score questionnaire 9. Change in IBS quality of life (QoL) questionnaire scores measured using LIFE measures IBS-QOL questionnaire Safety Endpoints: The incidence, nature, severity, relatedness, duration, outcome, seriousness and expectedness of treatment-emergent adverse events, measured by patient reporting during the study at any timepoint Missing Data: Subjects with missing efficacy data will be analysed on a last-observation-carried-forward basis |
| Overall study start date | 14/10/2022 |
| Completion date | 28/10/2024 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 9 |
| Key inclusion criteria | 1. Aged 18-65 years 2. Current symptoms of IBS (abdominal pain and altered bowel habit) ROME IV criteria 3. Prepared to take ERME (JUVIA) for the duration (taste test available for the patient) 4. Normal full blood count within the last 12 months (from medical notes if available) 5. Previous calprotectin (from medical notes if available) <80.ug/g 6. Previous tissue transglutaminase (tTG) (from medical notes if available) 7. Positive for malfermentation as decided by IBS Questionnaire Score 8. Registered with a GP and consent to GP being informed |
| Key exclusion criteria | 1. Pregnant, planning to become pregnant or lactating 2. Diabetic (or other co-morbidity that 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 the discretion of the CI) 5. Antibiotics in the previous 6 weeks 6. Other gastrointestinal disease (e.g. coeliac, Crohn’s disease or Ulcerative colitis ) 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 enrolment | 01/06/2023 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Seaway Parade Industrial Estate
Baglan
Port Talbot
SA12 7BR
United Kingdom
Sponsor information
Industry
21 Albermarle Street
London
W1S 4BS
England
United Kingdom
| Phone | +44 (0)1792 530819 |
|---|---|
| john.hunter@tharos.co.uk |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | A final report will be completed and either a full report or summary will be submitted to the REC and R&D after perusal and consent from the Sponsor. It is intended to publish the results whether positive or negative, in both abstracts and major gastroenterological journals. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as it is a small pilot study |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 02/05/2023 | 09/05/2023 | No | Yes | |
| Protocol file | 02/05/2023 | 09/05/2023 | No | No | |
| HRA research summary | 20/09/2023 | No | No |
Additional files
Editorial Notes
20/06/2024: The study stopped due to slow recruitment and changes in sponsor study support having recruited 9 participants.
20/02/2024: The following changes were made to the trial record:
1. The overall end date was changed from 28/05/2024 to 28/10/2024.
2. The intention to publish date was changed from 01/07/2024 to 01/12/2024.
3. The plain English summary was updated to reflect these changes.
4. The recruitment end date was changed from 29/02/2024 to 30/06/2024.
20/09/2023: A link to the HRA research summary was added.
05/06/2023: Internal review.
09/05/2023: Trial's existence confirmed by Wales REC 6.
