Clinical trial NCT01609751: Prevention of Diverticulitis by Taking a Daily Probiotic
Official title: Does a Daily Dose of the Probiotic Lactobacillus Casei Shirota Prevent Acute Episodes of Diverticulitis (LACTOPRoD) - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Diverticulitis
Keywords: probiotic
lactobacillus
colonic diseases
dietary fibre
Lead sponsor: University of Surrey
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of episodes of acute diverticulitis
timeFrame: 12 months period of taking daily probiotic
Secondary outcomes:
measure: Gut symptoms assessed by a validated questionnaire at o months, 6 months and 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Surrey Primary Care Trust practices
state: Surrey
Study officials:
affiliation: University of Surrey
name: Simon de Lusignan, MB ChB
role: STUDY_DIRECTOR
affiliation: University of Surrey
name: John AA Nichols, MB ChB
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Surrey
name: Michelle Gibbs, BSc PhD
role: STUDY_DIRECTOR
References:
citation: Narula N, Marshall JK. Role of probiotics in management of diverticular disease. J Gastroenterol Hepatol. 2010 Dec;25(12):1827-30. doi: 10.1111/j.1440-1746.2010.06444.x.
citation: Annibale B, Maconi G, Lahner E, De Giorgi F, Cuomo R. Efficacy of Lactobacillus paracasei sub. paracasei F19 on abdominal symptoms in patients with symptomatic uncomplicated diverticular disease: a pilot study. Minerva Gastroenterol Dietol. 2011 Mar;57(1):13-22.
citation: Bovenschen HJ, Janssen MJ, van Oijen MG, Laheij RJ, van Rossum LG, Jansen JB. Evaluation of a gastrointestinal symptoms questionnaire. Dig Dis Sci. 2006 Sep;51(9):1509-15. doi: 10.1007/s10620-006-9120-6. Epub 2006 Aug 22.
citation: Hammerman C, Bin-Nun A, Kaplan M. Safety of probiotics: comparison of two popular strains. BMJ. 2006 Nov 11;333(7576):1006-8. doi: 10.1136/bmj.39010.630799.BE. No abstract available.