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| ID | Type | Description | Link |
|---|---|---|---|
| Yakult UK | Other Grant/Funding Number | PO8959 |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yakult 62 ml daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surrey Primary Care Trust practices | Guildford | Surrey | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21091992 | Background | 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. | |
| 21372765 | 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. |
| Label | URL |
|---|---|
| Register using email address and search for "Find the science" then "Glossary" | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 26, 2023 | |
| Reset | Feb 12, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2023 | Feb 12, 2024 |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 16927133 | 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. |
| 17095783 | 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. |