Diverticular disease Nutritional, Metabolic, Endocrine Diverticular disease of intestine
Conditions
Interventions
Symprove probiotic dietary supplement (1 ml/kg) or placebo. Following a 1 week run in period, all patients will receive 12 weeks of treatment (either placebo or active treatment) followed by a further
Sponsors
King's College Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Aged less than 18 years and greater than 80 years 2. Severe disease (ongoing severe active diverticulitis) as defined by hemoglobin 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Global Symptom Severity Score and specific symptom sub-scores (abdominal pain, bloating, stool frequency and stool consistency) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in quality of life (QOL) as measured by a validated QOL questionnaire on week 12 of the study 2. Improvement in Sleep Quality Assessment | — |
Countries
United Kingdom
Outcome results
None listed