Does Mechanical Bowel Preparation Destabilise the Gut Microbiota and Provide a Window of Opportunity in Which to Influence the Re-establishing Microbiota in Diverticulosis?
Sponsor study identifier
observational
15
0 countries
N/A
Study Start
May 1, 2018
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Primary Completion
October 1, 2018
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Study Completion
April 30, 2019
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The mechanical bowel preparation (BP) used to clean the colon prior to colonoscopy frequently results in a significant but temporary reduction in patient's symptoms for a number of bowel disorders including symptomatic uncomplicated diverticular disease. The cause of this improvement is unknown. We hypothesise that changes to the gut microbial population (microbiota) are responsible for this improvement and that the repopulation of the GI tract with bacteria following colonoscopy results in a return of their normal symptoms. This pilot study will test this in a preliminary way by examining the stool, urine and blood of patients before and after bowel preparation to detect any destabilising effect that BP has on the gut microbiota and to what extent the microbiota repopulates at 3 months If the hypothesis is proven, this study will show that BP generates a 'window of opportunity' in which to influence the subsequent re-establishment of the microbiota. This is with the eventual aim of correcting potential dysbiosis and preventing the progression of symptomatic uncomplicated diverticular disease (SUDD).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2019
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March 7, 2018
Actual (reported)March 14, 2018
Actual (reported)May 1, 2018
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October 1, 2018
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April 30, 2019
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Composition of the colonic microbiota pre and post bowel preparation
Quantify sustained observational changes which occur within the functional groups of the gut microbiota following BP (HTP FISHflow technology)
6 months
Activity of the microbiota pre and post bowel preparation
Functional consequences of observed changes to host metabolism, host-microbe co-metabolism and short chain fatty acid production. This will be assessed by NMR spectroscopy and gas chromatography respectively
6 months
Post-menopausal women with non-specific left side pain and altered bowel habit who are having mechanical bowel preparation for a colonoscopy
Bacterial composition and activity and patient's symptoms will be assessed pre and post bowel preparation taken as part of the preparation to have a pre-planned colonoscopy
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Post-menopausal women with non-specific left side pain and an altered bowel habit who are due to be investigated by colonoscopy
Drago L, Toscano M, De Grandi R, Casini V, Pace F. Persisting changes of intestinal microbiota after bowel lavage and colonoscopy. Eur J Gastroenterol Hepatol. 2016 May;28(5):532-7. doi: 10.1097/MEG.0000000000000581.
Lozupone CA, Stombaugh JI, Gordon JI, Jansson JK, Knight R. Diversity, stability and resilience of the human gut microbiota. Nature. 2012 Sep 13;489(7415):220-30. doi: 10.1038/nature11550.
Stool and urine will be taken for analysis
Marie Lewis, PhD
Reading University
First Submitted
March 7, 2018
First Posted
March 14, 2018
Study Start
May 1, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 1, 2018
Intestinal Microbiota and Thyroid Cancer
Contact the study team to confirm eligibility.
Merrifield CA, Lewis MC, Claus SP, Pearce JT, Cloarec O, Duncker S, Heinzmann SS, Dumas ME, Kochhar S, Rezzi S, Mercenier A, Nicholson JK, Bailey M, Holmes E. Weaning diet induces sustained metabolic phenotype shift in the pig and influences host response to Bifidobacterium lactis NCC2818. Gut. 2013 Jun;62(6):842-51. doi: 10.1136/gutjnl-2011-301656. Epub 2012 Jun 3.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 14, 2018
Record last verified: 2018-03
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