Juvia being used for irritable bowel syndrome

Not Applicable

• Conditions: Irritable bowel syndrome (IBS); Digestive System; Irritable bowel syndrome

• Registration Number: ISRCTN14003582
• Lead Sponsor: Ateria Health Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-10
• Last Update Posted: 8 July 2024
• Study Completion: 2024-10-28

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 9

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IBS severity measured using IBS severity score questionnaire from baseline (visit 1) to 4 weeks (visit 2)