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