Clincosm LogoSign in Get a demo

LACTOPRoD: Prevention of Diverticulitis by Taking a Daily Probiotic

Sponsor
University of Surrey (Other)
Overall Status
Completed
CT.gov ID
NCT01609751
Collaborator
(none)
26
Enrollment
1
Location
1
Arm
21
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Yakult
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Does a Daily Dose of the Probiotic Lactobacillus Casei Shirota Prevent Acute Episodes of Diverticulitis (LACTOPRoD) - a Pilot Study
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of episodes of acute diverticulitis [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

    Secondary Outcome Measures

    1. Gut symptoms assessed by a validated questionnaire at o months, 6 months and 12 months [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Surrey Primary Care Trust practices Guildford Surrey United Kingdom

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University of Surrey
    ClinicalTrials.gov Identifier:
    NCT01609751
    Other Study ID Numbers:
    • SPCRU2
    • Yakult UK
    First Posted:
    Jun 1, 2012
    Last Update Posted:
    Mar 2, 2016
    Last Verified:
    Mar 1, 2016
    Keywords provided by University of Surrey
    probiotic
    lactobacillus
    colonic diseases
    dietary fibre
    Additional relevant MeSH terms:
    Diverticulitis

    Study Results

    No Results Posted as of Mar 2, 2016