Prevention of Diverticulitis by Taking a Daily Probiotic

Acute Diverticulitis Clinical Trial

— LACTOPRoD  

Official title:

Does a Daily Dose of the Probiotic Lactobacillus Casei Shirota Prevent Acute Episodes of Diverticulitis (LACTOPRoD) - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609751
• Other study ID #: SPCRU2
• Secondary ID: Yakult UK
• Status: Completed
• Phase: N/A
• First received: May 29, 2012
• Last updated: March 1, 2016
• Start date: April 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2016
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Diverticulitis
• Diverticulitis

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Surrey Primary Care Trust practices	Guildford	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
University of Surrey

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View 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. Epub 2006 Aug 22. — View Citation

Hammerman C, Bin-Nun A, Kaplan M. Safety of probiotics: comparison of two popular strains. BMJ. 2006 Nov 11;333(7576):1006-8. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes of acute diverticulitis	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	12 months period of taking daily probiotic	No
Secondary	Gut symptoms assessed by a validated questionnaire at o months, 6 months and 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	12 months	No

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