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Prevention of Diverticulitis by Taking a Daily Probiotic (LACTOPRoD)

This study is not yet open for participant recruitment.
Verified May 2012 by University of Surrey
Sponsor:
Information provided by (Responsible Party):
University of Surrey
ClinicalTrials.gov Identifier:
NCT01609751
First received: May 29, 2012
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

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 reduce 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 Intervention
Acute Diverticulitis
 Dietary Supplement: Yakult, one daily (containing a concentrated dose of Lactobacillus casei Shirota)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Surrey:

Primary Outcome Measures:
  • Number of episodes of acute diverticulitis [ Time Frame: 12 months period of taking daily probiotic ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Yakult, one daily (containing a concentrated dose of Lactobacillus casei Shirota)
    Yakult one daily for 12 months, this requires an intact cold chain and a refrigerator will be used to store deliveries of Yakult at the local primary care premises for the participants to collect every two weeks.
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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609751

Contacts
Contact: John AA Nichols, MB, ChB 01483564967 drjaan@ntlworld.com
Contact: Simon de Lusignan, MB, ChB 01483 68 3089 s.lusignan@surrey.ac.uk

Locations
United Kingdom
Surrey Primary Care Trust practices Not yet recruiting
Guildford area, Surrey, United Kingdom
Contact: John A A Nichols, MB, ChB            
Principal Investigator: John A A Nichols, MB, ChB            
Sponsors and Collaborators
University of Surrey
  More Information

Publications:

Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT01609751     History of Changes
Other Study ID Numbers: SPCRG2, Yakult UK
Study First Received: May 29, 2012
Last Updated: May 31, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Surrey:
probiotic
lactobacillus
colonic diseases
dietary fibre

Additional relevant MeSH terms:
Diverticulitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013