Acute DiverticulitisLACTOPRoDNCT01609751
Prevention of Diverticulitis by Taking a Daily Probiotic
A study testing Yakult in people with Acute Diverticulitis, run by University of Surrey at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Acute Diverticulitis
- What is being tested?
- Yakult
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- Undergoing immunosuppressive therapy or treatment
- Lactose intolerance or intolerance to dairy products
- Immunosuppressed patients
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Surrey Primary Care Trust practices
Guildford, Surrey
About this study
Official title: Does a Daily Dose of the Probiotic Lactobacillus Casei Shirota Prevent Acute Episodes of Diverticulitis (LACTOPRoD) - a Pilot Study
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.
Read the 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:
- 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.
- Conditions
- Acute Diverticulitis
- Being tested
- Yakult
- Keywords
- probiotic, lactobacillus, colonic diseases, dietary fibre
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YakultDietary supplement
Also called lactobacillus casei Shirota
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.
| Study group | Role | What they receive |
|---|---|---|
| Yakult 62 ml daily | Experimental | Not described Receives: Dietary Supplement: Yakult |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startApr 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon de Lusignan, MB ChB, Study director, University of SurreyJohn AA Nichols, MB ChB, Principal investigator, University of SurreyMichelle Gibbs, BSc PhD, Study director, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609751
- Sponsor's protocol ID
- SPCRU2
- Other IDs
- Yakult UK
- Acronym
- LACTOPRoD
- Status last verified
- Mar 2016
- First submitted
- 29 May 2012
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21091992Annibale 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.
PubMed 21372765Bovenschen 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.
PubMed 16927133Hammerman 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.
PubMed 17095783
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Daily Dose of the Probiotic Lactobacillus Casei Shirota Prevent Acute Episodes of Diverticulitis (LACTOPRoD) - a Pilot Study
- ClinicalTrials.gov ID
- NCT01609751
- Acronym / sponsor ID
- LACTOPRoD / SPCRU2
- Conditions
- Acute Diverticulitis
- Keywords
- probiotic, lactobacillus, colonic diseases, dietary fibre
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 1 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yakult 62 ml daily | Experimental | Dietary Supplement: Yakult |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YakultAlso: lactobacillus casei Shirota62 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. | Dietary supplement | Yakult 62 ml daily |
Primary outcome
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
1 secondary outcome
Gut symptoms assessed by a validated questionnaire at o months, 6 months and 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Background: PubMed 21091992Narula 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.
- Background: PubMed 21372765Annibale 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.
- Background: PubMed 16927133Bovenschen 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.
- Background: PubMed 17095783Hammerman 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.
- Register using email address and search for "Find the science" then "Glossary"Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon de Lusignan, MB ChB study director
University of Surrey
John AA Nichols, MB ChB principal investigator
University of Surrey
Michelle Gibbs, BSc PhD study director
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yakult in people with Acute Diverticulitis, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of episodes of acute diverticulitis (time frame: 12 months period of taking daily probiotic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01609751, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.