Assessment of the probiotic Symprove as a dietary supplement in patients with symptomatic diverticular disease
- Conditions
- Diverticular diseaseNutritional, Metabolic, EndocrineDiverticular disease of intestine
- Registration Number
- ISRCTN71661079
- Lead Sponsor
- King's College Hospital (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
1. Have a documented episode of diverticulitis as assesses clinically, on CT scans and a raised serological markers of inflammation
2. Have problematic symptoms associated with established diverticular disease
3. Aged between 18 and 80 years
4. Are on no treatment or have been on stabile medication for at least 6 weeks for diverticular disease
5. Willing and able to provide a written informed consent
1. Aged less than 18 years and greater than 80 years
2. Severe disease (ongoing severe active diverticulitis) as defined by hemoglobin < 8.0 g/dl, white blood cell count >20,000 cells/mm3, temperature >38.5°C, albumin < 25 g/dl
3. Diverticular complications such as recto-vaginal or bladder fistula, abscess, etc.
4. Severe respiratory, cardiovascular, neurological, psychiatric, rheumatological diseases
5. Undergone major intestinal resections
6. Patients with malignancy
7. On NSAIDs
8. Pregnancy or actively seeking pregnancy
9. History of intolerance or allergy to probiotics
10. Current drug or alcohol dependence syndrome
11. Pregnancy
12. Patients with severe learning difficulties
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in Global Symptom Severity Score and specific symptom sub-scores (abdominal pain, bloating, stool frequency and stool consistency)
- Secondary Outcome Measures
Name Time Method 1. Improvement in quality of life (QOL) as measured by a validated QOL questionnaire on week 12 of the study <br>2. Improvement in Sleep Quality Assessment