Prevention of Diverticulitis by Taking a Daily Probiotic

NCT01609751 | Completed DMC

• 2 other identifiers: SPCRU2Yakult UK
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Diverticulitis

Keywords

probiotic; lactobacillus; colonic diseases; dietary fibre

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Gut symptoms assessed by a validated questionnaire at o months, 6 months and 12 months

  12 months

Study Arms (1)

Yakult 62 ml daily

EXPERIMENTAL

Dietary Supplement: Yakult

Interventions

Yakult DIETARY_SUPPLEMENT

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.

Also known as: lactobacillus casei Shirota

Yakult 62 ml daily

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A history of two episodes of UAD treated with antibiotics in the last five years.
• Diverticulosis confirmed by colonoscopy, barium enema, USS, CT or MRI imaging or at surgery.
• Agreement to consume one bottle of Yakult daily for 12 months
• Availability of space in the domestic refrigerator for storage of Yakult units
• Able to access depot (local primary care premises or chemist) to collect regular supplies of Yakult
• Able to cope with keeping a diary etc.
• 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
• Capable of giving informed consent
• Aged ≥ 50 and ≤ 75 years at commencement of trial.

You may not qualify if:

• Recent history of peptic ulcer
• Chronic renal insufficiency
• Ongoing or past major diverticulitis complications
• Any serious debilitating illness (cancers, cardiovascular disease etc. but not DM)
• Dementias or memory problems
• Regular probiotic consumption over the past year.
• Undergoing immunosuppressive therapy or treatment
• Lactose intolerance or intolerance to dairy products
• Immunosuppressed patients

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (1)

Surrey Primary Care Trust practices

Guildford, Surrey, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 21091992 BACKGROUND

• 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.

  PMID: 21372765 BACKGROUND

• 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.

  PMID: 16927133 BACKGROUND

• 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.

  PMID: 17095783 BACKGROUND

Related Links

• Register using email address and search for "Find the science" then "Glossary"

MeSH Terms

Conditions

Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Simon de Lusignan, MB ChB

  University of Surrey

  STUDY DIRECTOR

• John AA Nichols, MB ChB

  University of Surrey

  PRINCIPAL INVESTIGATOR

• Michelle Gibbs, BSc PhD

  University of Surrey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 1, 2012
• Study Start: April 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 2, 2016

Record last verified: 2016-03

Locations

GB (1)