Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ingvar Bjarnason

ORCID ID

Contact details

Department of Gastroenterology
Kings College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Drug

Phase

Not Applicable

Drug names

Probiotic Symprove

Primary outcome measures

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 trial start date

01/01/2013

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant 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

Recruitment start date

01/01/2013

Recruitment end date

31/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Gastroenterology
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

King's College Hospital (UK)

Sponsor details

c/o Prof. Ingvar Bjarnason
Department of Gastroenterology
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.kch.nhs.uk

Funders

Funder type

Hospital/treatment centre

Funder name

King's College Hospital NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Editorial Notes