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Completed

NCT Number: NCT01609751

Prevention of Diverticulitis by Taking a Daily Probiotic

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.

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Key information

Conditions

Acute Diverticulitis Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Surrey Primary Care Trust practices

Guildford, Surrey, United Kingdom

About this study

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:

  • Monitoring dietary fibre using a diet diary
  • Measurement of height and weight to determine BMI
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: lactobacillus casei Shirota

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Surrey

Other

Registry information

Official study title

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

Acronym: LACTOPRoD

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 1, 2012
Registry last updated
Mar 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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