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31 October 2014 
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Assessment of the probiotic Symprove as a dietary supplement in patients with symptomatic diverticular disease
ISRCTN ISRCTN71661079
DOI 10.1186/ISRCTN71661079
ClinicalTrials.gov identifier
EudraCT number
Public title Assessment of the probiotic Symprove as a dietary supplement in patients with symptomatic diverticular disease
Scientific title Assessment of the probiotic Symprove as a dietary supplement in patients with symptomatic diverticular disease: a double blind randomised placebo controlled trial
Acronym N/A
Serial number at source N/A
Study hypothesis The probiotic Symprove when taken as a dietary supplement can reduce symptom severity and significantly improve the quality of life (QOL) of patients with symptomatic diverticular disease
Lay summary Lay summary under review 3
Ethics approval Health Research Authority, NRES Committee London - Riverside, Bristol Research Ethics Committee Centre, 10 December 2012, REC reference: 12/LO/1695, IRAS project ID: 115448
Study design Double blind randomised placebo controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Diverticular disease
Participants - 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
Participants - exclusion criteria 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
Anticipated start date 01/01/2013
Anticipated end date 31/12/2014
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 200
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 4 week follow up. Patient randomisation in a 2:1 ratio active:placebo.
Primary outcome measure(s) Improvement in Global Symptom Severity Score and specific symptom sub-scores (abdominal pain, bloating, stool frequency and stool consistency)
Secondary outcome measure(s) 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
Sources of funding King's College Hospital NHS Foundation Trust (UK)
Trial website
Publications
Contact name Prof  Ingvar  Bjarnason
  Address Department of Gastroenterology
Kings College Hospital
Denmark Hill
  City/town London
  Zip/Postcode SE5 9RS
  Country United Kingdom
Sponsor King's College Hospital (UK)
  Address c/o Prof. Ingvar Bjarnason
Department of Gastroenterology
King's College Hospital
Denmark Hill
  City/town London
  Zip/Postcode SE5 9RS
  Country United Kingdom
  Sponsor website: http://www.kch.nhs.uk
Date applied 05/02/2013
Last edited 18/02/2013
Date ISRCTN assigned 08/02/2013
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