The Gut Microbiome in Diverticulitis and Diverticulosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02221713 |
Recruitment Status :
Withdrawn
(lack of funding)
First Posted : August 20, 2014
Last Update Posted : April 2, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease |
---|
Diverticulitis Diverticulosis Diverticular Disease |

Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Family-Based |
Time Perspective: | Cross-Sectional |
Official Title: | Assessment of the Gut Microbiome in Diverticulitis and Diverticulosis |
Estimated Study Start Date : | June 2020 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | May 2021 |

Group/Cohort |
---|
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.
|
- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221713
United Kingdom | |
King's College Hospital | |
London, United Kingdom, se59rs |
Principal Investigator: | Ingvar Bjarnason, MD, MSc FRCPath, FRCP(Glasg) | King's College Hospital NHS Trust |
Responsible Party: | King's College Hospital NHS Trust |
ClinicalTrials.gov Identifier: | NCT02221713 |
Other Study ID Numbers: |
IRAS 163084 |
First Posted: | August 20, 2014 Key Record Dates |
Last Update Posted: | April 2, 2020 |
Last Verified: | March 2020 |
diverticulitis diverticulosis diverticular disease |
Diverticulitis Diverticular Diseases Diverticulum Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Pathological Conditions, Anatomical |