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Prevention of Diverticulitis by Taking a Daily Probiotic (LACTOPRoD)

Primary Purpose

Acute Diverticulitis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Yakult
Sponsored by
University of Surrey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Diverticulitis focused on measuring probiotic, lactobacillus, colonic diseases, dietary fibre

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. A history of two episodes of UAD treated with antibiotics in the last five years.
  2. Diverticulosis confirmed by colonoscopy, barium enema, USS, CT or MRI imaging or at surgery.
  3. Agreement to consume one bottle of Yakult daily for 12 months
  4. Availability of space in the domestic refrigerator for storage of Yakult units
  5. Able to access depot (local primary care premises or chemist) to collect regular supplies of Yakult
  6. Able to cope with keeping a diary etc.
  7. Willing to take Yakult supplies and a cold bag on holiday to ensure as near as possible continuous daily doses (certainly never more than one week break as Lactobacilli casei will persist in the human gut for at least one week
  8. Capable of giving informed consent
  9. Aged ≥ 50 and ≤ 75 years at commencement of trial.

Exclusion Criteria:

  1. Recent history of peptic ulcer
  2. Chronic renal insufficiency
  3. Ongoing or past major diverticulitis complications
  4. Any serious debilitating illness (cancers, cardiovascular disease etc. but not DM)
  5. Dementias or memory problems
  6. Regular probiotic consumption over the past year.
  7. Undergoing immunosuppressive therapy or treatment
  8. Lactose intolerance or intolerance to dairy products
  9. Immunosuppressed patients

Sites / Locations

  • Surrey Primary Care Trust practices

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yakult 62 ml daily

Arm Description

Outcomes

Primary Outcome Measures

Number of episodes of acute diverticulitis
An episode of diverticulitis will be judged as having occured when there is left iliac pain and tenderness judged by the patient's genral practitioner to be due to acute diverticulitis and to be sufficiently severe as to require a course of antibiotics

Secondary Outcome Measures

Gut symptoms assessed by a validated questionnaire at o months, 6 months and 12 months
The Bovenschen GIT symptom questionnaire (Bovenschen HJ, Janssen MJR, van Oijen MGH, Laheij RJF, van Rossum LGM, Jansen JBMJ (2006).Evaluation of Gastrolintestinal symptoms questionnaire. Digestive Diseases and Science;51:1509-1515.) will be used to assess this secondary endpoint

Full Information

First Posted
May 29, 2012
Last Updated
March 1, 2016
Sponsor
University of Surrey
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1. Study Identification

Unique Protocol Identification Number
NCT01609751
Brief Title
Prevention of Diverticulitis by Taking a Daily Probiotic
Acronym
LACTOPRoD
Official Title
Does a Daily Dose of the Probiotic Lactobacillus Casei Shirota Prevent Acute Episodes of Diverticulitis (LACTOPRoD) - a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Surrey

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
There is evidence to show that daily probiotic Lactobacillus casei Shirota (LcS) in the form of Yakult fermented milk supports a healthy balanced population of "friendly" gut bacteria. This, coupled with evidence from four European trials showing probiotic benefit for recurrent diverticulitis and an understanding of how the disease develops, indicates that LcS may also be beneficial. The investigators plan to undertake a pilot study investigating whether consumption of once daily probiotic LcS as Yakult fermented milk would help either prevent attacks of diverticulitis completely or significantly reduce frequency of attacks. Subjects will be recruited from Surrey primary care units and will be closely monitored for 12 months whilst being supplied with a daily dose of for the full 12 months to see if this improves gut health.
Detailed Description
Because dietary fibre, obesity and diabetes are all confounding factors that influence the frequency and severity of attacks of diverticulitis, the research project will take account of this by: Monitoring dietary fibre using a diet diary Measurement of height and weight to determine BMI Screening for undiagnosed diabetes and pre-diabetes As well as keeping a diet diary, subjects will be asked to keep a general health diary, and to complete gut health questionnaires at start, 6 months and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diverticulitis
Keywords
probiotic, lactobacillus, colonic diseases, dietary fibre

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yakult 62 ml daily
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Yakult
Other Intervention Name(s)
lactobacillus casei Shirota
Intervention Description
62 ml dose daily for 365 days. There must be a cold chain from supplier (Yakult UK) via the primary care centre to the trial participants.
Primary Outcome Measure Information:
Title
Number of episodes of acute diverticulitis
Description
An episode of diverticulitis will be judged as having occured when there is left iliac pain and tenderness judged by the patient's genral practitioner to be due to acute diverticulitis and to be sufficiently severe as to require a course of antibiotics
Time Frame
12 months period of taking daily probiotic
Secondary Outcome Measure Information:
Title
Gut symptoms assessed by a validated questionnaire at o months, 6 months and 12 months
Description
The Bovenschen GIT symptom questionnaire (Bovenschen HJ, Janssen MJR, van Oijen MGH, Laheij RJF, van Rossum LGM, Jansen JBMJ (2006).Evaluation of Gastrolintestinal symptoms questionnaire. Digestive Diseases and Science;51:1509-1515.) will be used to assess this secondary endpoint
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A history of two episodes of UAD treated with antibiotics in the last five years. Diverticulosis confirmed by colonoscopy, barium enema, USS, CT or MRI imaging or at surgery. Agreement to consume one bottle of Yakult daily for 12 months Availability of space in the domestic refrigerator for storage of Yakult units Able to access depot (local primary care premises or chemist) to collect regular supplies of Yakult Able to cope with keeping a diary etc. Willing to take Yakult supplies and a cold bag on holiday to ensure as near as possible continuous daily doses (certainly never more than one week break as Lactobacilli casei will persist in the human gut for at least one week Capable of giving informed consent Aged ≥ 50 and ≤ 75 years at commencement of trial. Exclusion Criteria: Recent history of peptic ulcer Chronic renal insufficiency Ongoing or past major diverticulitis complications Any serious debilitating illness (cancers, cardiovascular disease etc. but not DM) Dementias or memory problems Regular probiotic consumption over the past year. Undergoing immunosuppressive therapy or treatment Lactose intolerance or intolerance to dairy products Immunosuppressed patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon de Lusignan, MB ChB
Organizational Affiliation
University of Surrey
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John AA Nichols, MB ChB
Organizational Affiliation
University of Surrey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelle Gibbs, BSc PhD
Organizational Affiliation
University of Surrey
Official's Role
Study Director
Facility Information:
Facility Name
Surrey Primary Care Trust practices
City
Guildford
State/Province
Surrey
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21091992
Citation
Narula N, Marshall JK. Role of probiotics in management of diverticular disease. J Gastroenterol Hepatol. 2010 Dec;25(12):1827-30. doi: 10.1111/j.1440-1746.2010.06444.x.
Results Reference
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PubMed Identifier
21372765
Citation
Annibale B, Maconi G, Lahner E, De Giorgi F, Cuomo R. Efficacy of Lactobacillus paracasei sub. paracasei F19 on abdominal symptoms in patients with symptomatic uncomplicated diverticular disease: a pilot study. Minerva Gastroenterol Dietol. 2011 Mar;57(1):13-22.
Results Reference
background
PubMed Identifier
16927133
Citation
Bovenschen HJ, Janssen MJ, van Oijen MG, Laheij RJ, van Rossum LG, Jansen JB. Evaluation of a gastrointestinal symptoms questionnaire. Dig Dis Sci. 2006 Sep;51(9):1509-15. doi: 10.1007/s10620-006-9120-6. Epub 2006 Aug 22.
Results Reference
background
PubMed Identifier
17095783
Citation
Hammerman C, Bin-Nun A, Kaplan M. Safety of probiotics: comparison of two popular strains. BMJ. 2006 Nov 11;333(7576):1006-8. doi: 10.1136/bmj.39010.630799.BE. No abstract available.
Results Reference
background
Links:
URL
http://hcp.yakult.co.uk
Description
Register using email address and search for "Find the science" then "Glossary"

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Prevention of Diverticulitis by Taking a Daily Probiotic

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