Prevention of Diverticulitis by Taking a Daily Probiotic (LACTOPRoD)

March 1, 2016 updated by: University of Surrey

Does a Daily Dose of the Probiotic Lactobacillus Casei Shirota Prevent Acute Episodes of Diverticulitis (LACTOPRoD) - a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. Monitoring dietary fibre using a diet diary
  2. Measurement of height and weight to determine BMI
  3. 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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom
        • Surrey Primary Care Trust practices

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yakult 62 ml daily
Dietary supplement: Yakult
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.
Other Names:
  • lactobacillus casei Shirota

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of episodes of acute diverticulitis
Time Frame: 12 months period of taking daily probiotic
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
12 months period of taking daily probiotic

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut symptoms assessed by a validated questionnaire at o months, 6 months and 12 months
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Surrey

Investigators

  • Study Director: Simon de Lusignan, MB ChB, University of Surrey
  • Principal Investigator: John AA Nichols, MB ChB, University of Surrey
  • Study Director: Michelle Gibbs, BSc PhD, University of Surrey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

May 29, 2012

First Submitted That Met QC Criteria

May 31, 2012

First Posted (Estimate)

June 1, 2012

Study Record Updates

Last Update Posted (Estimate)

March 2, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPCRU2
  • Yakult UK (Other Grant/Funding Number: PO8959)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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