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Prevention of Diverticulitis by Taking a Daily Probiotic (LACTOPRoD)

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ClinicalTrials.gov Identifier: NCT01609751
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
University of Surrey

Tracking Information
First Submitted Date  ICMJE May 29, 2012
First Posted Date  ICMJE June 1, 2012
Last Update Posted Date March 2, 2016
Study Start Date  ICMJE April 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01609751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2012)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Diverticulitis by Taking a Daily Probiotic
Official Title  ICMJE Does a Daily Dose of the Probiotic Lactobacillus Casei Shirota Prevent Acute Episodes of Diverticulitis (LACTOPRoD) - a Pilot Study
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:

  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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Diverticulitis
Intervention  ICMJE 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 Name: lactobacillus casei Shirota
Study Arms  ICMJE Experimental: Yakult 62 ml daily
Intervention: Dietary Supplement: Yakult
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2016)
26
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2012)
50
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01609751
Other Study ID Numbers  ICMJE SPCRU2
Yakult UK ( Other Grant/Funding Number: PO8959 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Surrey
Study Sponsor  ICMJE University of Surrey
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Surrey
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP