Trials / Completed
CompletedNCT01609751
Prevention of Diverticulitis by Taking a Daily Probiotic
Does a Daily Dose of the Probiotic Lactobacillus Casei Shirota Prevent Acute Episodes of Diverticulitis (LACTOPRoD) - a Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- University of Surrey · Academic / Other
- Sex
- All
- Age
- 50 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2015-01-01
- Completion
- 2015-01-01
- First posted
- 2012-06-01
- Last updated
- 2016-03-02
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01609751. Inclusion in this directory is not an endorsement.