Prevention of Diverticulitis by Taking a Daily Probiotic (LACTOPRoD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Surrey
ClinicalTrials.gov Identifier:
NCT01609751
First received: May 29, 2012
Last updated: March 1, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Acute Diverticulitis
Dietary Supplement: Yakult

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does a Daily Dose of the Probiotic Lactobacillus Casei Shirota Prevent Acute Episodes of Diverticulitis (LACTOPRoD) - a Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Surrey:

Primary Outcome Measures:
  • Number of episodes of acute diverticulitis [ Time Frame: 12 months period of taking daily probiotic ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Gut symptoms assessed by a validated questionnaire at o months, 6 months and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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


Enrollment: 26
Study Start Date: April 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yakult 62 ml daily 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.
Other Name: lactobacillus casei Shirota

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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609751

Locations
United Kingdom
Surrey Primary Care Trust practices
Guildford, Surrey, United Kingdom
Sponsors and Collaborators
University of Surrey
Investigators
Study Director: Simon de Lusignan, MB ChB University of Surrey
Principal Investigator: John AA Nichols, MB ChB University of Surrey
Study Director: Michelle Gibbs, BSc PhD University of Surrey
  More Information

Additional Information:
Publications:
Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT01609751     History of Changes
Other Study ID Numbers: SPCRU2  Yakult UK 
Study First Received: May 29, 2012
Last Updated: March 1, 2016
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Surrey:
probiotic
lactobacillus
colonic diseases
dietary fibre

Additional relevant MeSH terms:
Diverticulitis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Infection
Intraabdominal Infections

ClinicalTrials.gov processed this record on May 24, 2016