Assessment of the probiotic Symprove as a dietary supplement in patients with symptomatic diverticular disease
| ISRCTN | ISRCTN71661079 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71661079 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/02/2013
- Registration date
- 08/02/2013
- Last edited
- 19/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
In diverticulosis, small bulges develop in the lining of the large intestine (colon). Diverticulitis is when these bulges become inflamed or infected. Diverticulitis is an extremely common disease particularly found in elderly patients. Many patients with diverticulitis have symptoms such as diarrhoea, constipation and abdominal pain, similar to Irritable Bowel Syndrome (IBS). Different treatments have been proposed but they are unproven or controversial. It is thought that intestinal bacteria may be involved in the symptoms. As the probiotic dietary supplement Symprove has been found to reduce the symptoms of IBS, this study aims to test Symprove in patients with diverticulitis.
Who can participate?
Patients aged between 18 and 80 with diverticulitis.
What does the study involve?
Participants are randomly allocated to be treated with either Symprove or placebo (dummy treatment) for 12 weeks followed by a further 4-week follow-up.
What are the possible benefits and risks of participating?
Symprove may be able to help reduce the severity of diverticular disease symptoms such as pain, diarrhoea, constipation and bloating. There are no known risks of drinking Symprove.
Where is the study run from?
King's College Hospital Gastroenterology Department (UK).
When is the study starting and how long is it expected to run for?
January 2013 to December 2014.
Who is funding the study?
King's College Hospital NHS Foundation Trust (UK).
Who is the main contact?
Prof. Ingvar Bjarnason
Contact information
Scientific
Department of Gastroenterology
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Study information
| Study design | Double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Assessment of the probiotic Symprove as a dietary supplement in patients with symptomatic diverticular disease: a double blind randomised placebo controlled trial |
| Study objectives | 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. |
| Ethics approval(s) | Health Research Authority, NRES Committee London - Riverside, Bristol Research Ethics Committee Centre, 10/12/2012, REC ref: 12/LO/1695, IRAS project ID: 115448 |
| Health condition(s) or problem(s) studied | Diverticular disease |
| Intervention | 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. |
| Intervention type | Supplement |
| Primary outcome measure | Improvement in Global Symptom Severity Score and specific symptom sub-scores (abdominal pain, bloating, stool frequency and stool consistency) |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2013 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE5 9RS
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Prof. Ingvar Bjarnason
Department of Gastroenterology
King's College Hospital
Denmark Hill
London
SE5 9RS
England
United Kingdom
| Website | http://www.kch.nhs.uk |
|---|---|
"ROR" |
https://ror.org/01qz4yx77 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
19/12/2017: Publication reference added.
