Influence of Mechanical Bowel Preparation on GI Microbiota

NCT03465293 | Unknown

• 1 other identifier: FNSML1
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Diverticulosis, Colonic; Microbiota

Keywords

Symptomatic diverticulosis; Microbiota; Bowel preparation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

SUDD post-menopausal female

Post-menopausal women with non-specific left side pain and altered bowel habit who are having mechanical bowel preparation for a colonoscopy

Other: Bacterial composition and activity after bowel preparation

Interventions

Bacterial composition and activity after bowel preparation OTHER

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

SUDD post-menopausal female

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post-menopausal women with non-specific left side pain and an altered bowel habit who are due to be investigated by colonoscopy

You may qualify if:

• Suspected symptomatic uncomplicated diverticular disease
• Requires colonoscopy for investigation of symptoms

You may not qualify if:

• Under 18yo
• Previous bowel resection
• Antibiotics use in the last 6 months
• Medical condition precluding colonoscopy

Sponsors & Collaborators

• University of Reading: lead
• Royal Berkshire Hospital: collaborator

Related Publications (3)

• 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.

  PMID: 27015015 RESULT

• 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.

  PMID: 22972295 RESULT

• 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.

  PMID: 22661492 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool and urine will be taken for analysis

MeSH Terms

Conditions

Diverticulosis, Colonic

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Marie Lewis, PhD

  Reading University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Lewis, PhD

CONTACT

0118 378 8708; marie.lewis@reading.ac.uk

Philip Conaghan, MA DM FRCS

CONTACT

philip.conaghan@royalberkshire.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: May 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: April 30, 2019
• Last Updated: March 14, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share