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The Gut Microbiome in Diverticulitis and Diverticulosis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2015 by King's College Hospital NHS Trust
Sponsor:
Information provided by (Responsible Party):
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT02221713
First received: August 19, 2014
Last updated: September 10, 2015
Last verified: September 2015
  Purpose

Colonic diverticula are outpouchings of the large bowel, and they occur in up to 60% of people over 60 years of age. About 10-25% of patients with diverticula will have symptoms. These can range from acute diverticulitis, which can be a lethal infection to symptomatic diverticular disease, which involves inflammation of the bowel and altered bowel habits, decreasing patients' quality of life. We do not know which patients will develop acute diverticulitis or which patients will develop diverticula in their colon.

We believe that diverticulitis may be associated with, or even caused by, alterations in the bacteria that live in the colon, known as the gut microbiome. Until recently it was too expensive and too complex to examine the microbiome in detail. We propose to examine for the first time in detail the microbiome of patients with acute diverticulitis and asymptomatic diverticulosis.

Stool samples will be analysed for gut microbiome composition by 16S ribosomal RNA gene pyrosequencing. There is a part of the bacterial cell, the ribosome, which is the same in all bacteria (16S). Through PCR, polymerase chain reaction, and sequencing, we can separate out the different types of bacteria in a sample. We can then look at the different kinds of bacteria in each patient population, as well as how diverse the populations are within the groups, and compared to other groups.

We hope to be able to discriminate between the microbiome of patients with acute diverticulitis and asymptomatic diverticulosis. This study many change how diverticulitis and diverticulosis are conceptualized and treated. Alterations in the microbiome in these disease states may be able to be treated, preventing further disease.


Condition
Diverticulitis
Diverticulosis
Diverticular Disease

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Assessment of the Gut Microbiome in Diverticulitis and Diverticulosis

Resource links provided by NLM:


Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • assessment of gut microbiome [ Time Frame: at time of enrollment ]
    Patients will give stool specimen or rectal swab after enrolling in the study. Stool samples will undergo 16S rRNA pyrosequencing for microbiome analysis.


Biospecimen Retention:   Samples With DNA
stool samples and rectal swabs of stool

Estimated Enrollment: 100
Study Start Date: December 2015
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group A: perforated diverticulitis
Patients with acute diverticulitis will be recruited from the A&E department at King's, prior to commencement of antibiotics. Rectal swabs will be obtained from patients with a chief complaint of acute abdominal pain upon initial assessment, prior to initial antibiotics. All specimens will be initially frozen, but only patients specimens with an admitting diagnosis of acute diverticulitis and colonic imaging (CT imaging or visualization at surgery) will be analysed. This group will include patients with perforated diverticulitis (i.e., Hinchey III or IV).
Group B: unperforated diverticulitis
Patients with acute diverticulitis will be recruited from the A&E department at King's, prior to commencement of antibiotics. Rectal swabs will be obtained from patients with a chief complaint of acute abdominal pain upon initial assessment, prior to initial antibiotics. All specimens will be initially frozen, but only patients specimens with an admitting diagnosis of acute diverticulitis and colonic imaging (CT imaging or visualization at surgery) will be analysed. This group will include patients with unperforated diverticulitis (Hinchey I or II).
Group C: asymptomatic diverticulosis
Patients with asymptomatic diverticulosis will be recruited from the 2-week wait (2ww) colorectal cancer pathway. Patients presenting with a chief complaint of fresh PR bleeding, with no other complaints, will be recruited prior to diagnostic imaging, either by CT, CT colonography, or endoscopy. They will provide a stool sample or rectal swab prior to bowel cleansing, if required for their evaluation, as that may alter the microbiome. Those patient samples with diverticulosis (and or haemorrhoids, as the other most common cause of fresh PR bleeding) will be analysed.
Group D: normal controls
Patients with or without haemorrhoids, and no other colonic pathology will be recruited from the 2ww colorectal cancer pathway. These will be the normal controls. Patients presenting with a chief complaint of fresh PR bleeding, with no other complaints, will be recruited prior to diagnostic imaging, either by CT, CT colonography, or endoscopy. They will provide a stool sample or rectal swab prior to bowel cleansing, if required for their evaluation, as that may alter the microbiome. Those patient samples with diverticulosis (and or haemorrhoids, as the other most common cause of fresh PR bleeding) will be analysed.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Groups A and B. Patients with acute diverticulitis will be recruited from A&E at King's College Hospital. If they agree to participate, we will request either a stool sample to be produced, or, if that is not feasible, then a member of the study team will procure a rectal swab.

Those patients with Hinchey III or IV's specimens will be assessed in Group A, while those patients with Hinchey I or II will be assessed in Group B.

Groups C and D. Patients referred through the Two Week Wait (2ww) Colorectal Cancer pathway who are both at low risk for colorectal cancer and have low levels of anxiety, both as assessed by a physician outside the study team will be approached to participate. These patients will be able to produce the stool sample prior to presenting for flexible sigmoidoscopy as a part of their workup.

Criteria

Inclusion Criteria:

Groups A and B. Patients with acute diverticulitis - patients presenting to A&E at King's College Hospital with new onset abdominal pain, with or without a known diagnosis of diverticulitis

Groups C and D. Patients with asymptomatic diverticulosis and normal controls

- Patients being assessed through the 2ww Colorectal Cancer pathway with a chief complaint of fresh PR bleeding and no other 'red flag' symptoms, who are not overly anxious over their diagnosis as assessed by a physician outside the study team.

Exclusion Criteria:

Groups A and B. Patients with acute diverticulitis

  • Patients in extremis- e.g. systolic blood pressure less than 80 on arrival or pulse greater than 115
  • Patients who have received antibiotics in the three months prior to presentation.
  • Vulnerable patient populations

Groups C and D. Patients with asymptomatic diverticulosis and normal controls

  • Patients with high levels of pre-test anxiety, as determined by their assessing physician, outside the study team
  • Patients who received antibiotics for any reason in the 3 months prior to inclusion
  • Vulnerable patient populations
  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: NCT02221713

Contacts
Contact: Charlotte Kvasnovsky, MD, MPH +44(0)7539078406 ckvasnovsky@nhs.net

Locations
United Kingdom
King's College Hospital Not yet recruiting
London, United Kingdom, se59rs
Contact: Charlotte L Kvasnovsky, MD, MPH    +44(0)7539078406    ckvasnovsky@nhs.net   
Sub-Investigator: Charlotte Kvasnovsky, MD, MPH         
Sponsors and Collaborators
King's College Hospital NHS Trust
Investigators
Principal Investigator: Ingvar Bjarnason, MD, MSc FRCPath, FRCP(Glasg) King's College Hospital NHS Trust
  More Information

Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT02221713     History of Changes
Other Study ID Numbers: IRAS 163084
Study First Received: August 19, 2014
Last Updated: September 10, 2015

Keywords provided by King's College Hospital NHS Trust:
diverticulitis
diverticulosis
diverticular disease

Additional relevant MeSH terms:
Diverticulitis
Diverticulum
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 27, 2017