Clinical Trial: Prevention of Diverticulitis by Taking a Daily Probiotic

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: University of Surrey

Current Primary Outcome: 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: Same as current

Current Secondary Outcome: 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: Same as current

Information By: University of Surrey

Dates:
Date Received: May 29, 2012
Date Started: April 2013
Date Completion:
Last Updated: March 1, 2016
Last Verified: March 2016