Diverticulitis and Irritable Bowel SyndromeNCT02003807
Incidence and Predictive Factor of Irritable Bowel Syndrome After Acute Diverticulitis in Korea
An observational study of Diverticulitis and Irritable Bowel Syndrome, run by Yonsei University at 1 site in South Korea.
Trial summary
The pathogenesis of irritable bowel syndrome (IBS) is considered immune reaction of gastrointestinal tract. Therefore there is growing evidence that IBS could occur after gastroenteritis. However, little is known about the incidence of IBS after acute diverticulitis. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diverticulitis and Irritable Bowel Syndrome
- How many people
- 102 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who had admitted Severance hospital, Seoul, South Korea.
Who may be able to join
- 20 years or over
- Patients who diagnosed diverticulitis by CT scan from 2006 to 2010 (Case)
- Patients who admitted to hospital because of non-gastrointestinal disorder (Control)
Who cannot join
- Patients who diagnosed IBS before diverticulitis (Case)
- Patients who diagnosed IBS before admission (Control)
- Patients with bowel resection surgery except for laparoscopic appendectomy
- Pregnancy
- Do not agree the consent of this study
- Patients who dose not understand telephone survey such as foreigner, mental retardation.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752
About this study
The pathogenesis of irritable bowel syndrome (IBS) is considered immune reaction of gastrointestinal tract. Therefore there is growing evidence that IBS could occur after gastroenteritis. However, little is known about the incidence of IBS after acute diverticulitis. We thought that post diverticulitis status could induce IBS because diverticulitis was also bowel inflammatory disorder. This survey was designed to identify incidence of post-diverticulitis IBS and risk factor in Korea.
- Medical subject headings
- Diverticulitis, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diverticulitis patients (case) | Cases were the patients who admitted to hospital because of acute diverticulitis attack. | |
| Non-diverticulitis patients (control) | Controls were the patients who admitted to hospital due to non-gastrointestinal disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The newly developed IBS
The primary outcome was newly developed IBS. This was checked by telephone survey from 15th July 2013 to 30th September 2013. IBS was diagnosed by Rome III criteria.
Measured: Survey was done from 15th July 2013 to 30th September 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Diverticulitis and Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003807
- Sponsor's protocol ID
- 4-2013-0326
- Status last verified
- Dec 2013
- First submitted
- 2 Dec 2013
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
PubMed 22426087Ballou SK, Keefer L. Multicultural considerations in the diagnosis and management of irritable bowel syndrome: a selective summary. Eur J Gastroenterol Hepatol. 2013 Oct;25(10):1127-33. doi: 10.1097/MEG.0b013e3283632bf2.
PubMed 23778308Ohman L, Simren M. New insights into the pathogenesis and pathophysiology of irritable bowel syndrome. Dig Liver Dis. 2007 Mar;39(3):201-15. doi: 10.1016/j.dld.2006.10.014. Epub 2007 Jan 30.
PubMed 17267314Ishihara S, Tada Y, Fukuba N, Oka A, Kusunoki R, Mishima Y, Oshima N, Moriyama I, Yuki T, Kawashima K, Kinoshita Y. Pathogenesis of irritable bowel syndrome--review regarding associated infection and immune activation. Digestion. 2013;87(3):204-11. doi: 10.1159/000350054. Epub 2013 May 23.
PubMed 23712295Hughes PA, Zola H, Penttila IA, Blackshaw LA, Andrews JM, Krumbiegel D. Immune activation in irritable bowel syndrome: can neuroimmune interactions explain symptoms? Am J Gastroenterol. 2013 Jul;108(7):1066-74. doi: 10.1038/ajg.2013.120. Epub 2013 May 7.
PubMed 23649183Jung IS, Kim HS, Park H, Lee SI. The clinical course of postinfectious irritable bowel syndrome: a five-year follow-up study. J Clin Gastroenterol. 2009 Jul;43(6):534-40. doi: 10.1097/MCG.0b013e31818c87d7.
PubMed 19262407Zanini B, Ricci C, Bandera F, Caselani F, Magni A, Laronga AM, Lanzini A; San Felice del Benaco Study Investigators. Incidence of post-infectious irritable bowel syndrome and functional intestinal disorders following a water-borne viral gastroenteritis outbreak. Am J Gastroenterol. 2012 Jun;107(6):891-9. doi: 10.1038/ajg.2012.102. Epub 2012 Apr 24.
PubMed 22525306Ji S, Park H, Lee D, Song YK, Choi JP, Lee SI. Post-infectious irritable bowel syndrome in patients with Shigella infection. J Gastroenterol Hepatol. 2005 Mar;20(3):381-6. doi: 10.1111/j.1440-1746.2005.03574.x.
PubMed 15740480Spiller R, Garsed K. Postinfectious irritable bowel syndrome. Gastroenterology. 2009 May;136(6):1979-88. doi: 10.1053/j.gastro.2009.02.074. Epub 2009 May 7.
PubMed 19457422Strate LL, Modi R, Cohen E, Spiegel BM. Diverticular disease as a chronic illness: evolving epidemiologic and clinical insights. Am J Gastroenterol. 2012 Oct;107(10):1486-93. doi: 10.1038/ajg.2012.194. Epub 2012 Jul 10.
PubMed 22777341Cohen E, Fuller G, Bolus R, Modi R, Vu M, Shahedi K, Shah R, Atia M, Kurzbard N, Sheen V, Agarwal N, Kaneshiro M, Yen L, Hodgkins P, Erder MH, Spiegel B. Increased risk for irritable bowel syndrome after acute diverticulitis. Clin Gastroenterol Hepatol. 2013 Dec;11(12):1614-9. doi: 10.1016/j.cgh.2013.03.007. Epub 2013 Mar 21.
PubMed 23524129Rafferty J, Shellito P, Hyman NH, Buie WD; Standards Committee of American Society of Colon and Rectal Surgeons. Practice parameters for sigmoid diverticulitis. Dis Colon Rectum. 2006 Jul;49(7):939-44. doi: 10.1007/s10350-006-0578-2. No abstract available.
PubMed 16741596Hammond NA, Nikolaidis P, Miller FH. Left lower-quadrant pain: guidelines from the American College of Radiology appropriateness criteria. Am Fam Physician. 2010 Oct 1;82(7):766-70.
PubMed 20879699Thabane M, Kottachchi DT, Marshall JK. Systematic review and meta-analysis: The incidence and prognosis of post-infectious irritable bowel syndrome. Aliment Pharmacol Ther. 2007 Aug 15;26(4):535-44. doi: 10.1111/j.1365-2036.2007.03399.x.
PubMed 17661757Spiller R. Is it diverticular disease or is it irritable bowel syndrome? Dig Dis. 2012;30(1):64-9. doi: 10.1159/000335721. Epub 2012 May 3.
PubMed 22572688
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Predictive Factor of Irritable Bowel Syndrome After Acute Diverticulitis in Korea
- ClinicalTrials.gov ID
- NCT02003807
- Acronym / sponsor ID
- 4-2013-0326
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The pathogenesis of irritable bowel syndrome (IBS) is considered immune reaction of gastrointestinal tract. Therefore there is growing evidence that IBS could occur after gastroenteritis. However, little is known about the incidence of IBS after acute diverticulitis. We thought that post diverticulitis status could induce IBS because diverticulitis was also bowel inflammatory disorder. This survey was designed to identify incidence of post-diverticulitis IBS and risk factor in Korea.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diverticulitis patients (case) | – | –Cases were the patients who admitted to hospital because of acute diverticulitis attack. |
| Non-diverticulitis patients (control) | – | –Controls were the patients who admitted to hospital due to non-gastrointestinal disorder. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had admitted Severance hospital, Seoul, South Korea.
Key inclusion criteria (3 listed)
- 20 years or over
- Patients who diagnosed diverticulitis by CT scan from 2006 to 2010 (Case)
- Patients who admitted to hospital because of non-gastrointestinal disorder (Control)
Key exclusion criteria (6 listed)
- Patients who diagnosed IBS before diverticulitis (Case)
- Patients who diagnosed IBS before admission (Control)
- Patients with bowel resection surgery except for laparoscopic appendectomy
- Pregnancy
- Do not agree the consent of this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The newly developed IBS
Time frame: Survey was done from 15th July 2013 to 30th September 2013
The primary outcome was newly developed IBS. This was checked by telephone survey from 15th July 2013 to 30th September 2013. IBS was diagnosed by Rome III criteria.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
- Background: PubMed 22426087Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
- Background: PubMed 23778308Ballou SK, Keefer L. Multicultural considerations in the diagnosis and management of irritable bowel syndrome: a selective summary. Eur J Gastroenterol Hepatol. 2013 Oct;25(10):1127-33. doi: 10.1097/MEG.0b013e3283632bf2.
- Background: PubMed 17267314Ohman L, Simren M. New insights into the pathogenesis and pathophysiology of irritable bowel syndrome. Dig Liver Dis. 2007 Mar;39(3):201-15. doi: 10.1016/j.dld.2006.10.014. Epub 2007 Jan 30.
- Background: PubMed 23712295Ishihara S, Tada Y, Fukuba N, Oka A, Kusunoki R, Mishima Y, Oshima N, Moriyama I, Yuki T, Kawashima K, Kinoshita Y. Pathogenesis of irritable bowel syndrome--review regarding associated infection and immune activation. Digestion. 2013;87(3):204-11. doi: 10.1159/000350054. Epub 2013 May 23.
- Background: PubMed 23649183Hughes PA, Zola H, Penttila IA, Blackshaw LA, Andrews JM, Krumbiegel D. Immune activation in irritable bowel syndrome: can neuroimmune interactions explain symptoms? Am J Gastroenterol. 2013 Jul;108(7):1066-74. doi: 10.1038/ajg.2013.120. Epub 2013 May 7.
- Background: PubMed 19262407Jung IS, Kim HS, Park H, Lee SI. The clinical course of postinfectious irritable bowel syndrome: a five-year follow-up study. J Clin Gastroenterol. 2009 Jul;43(6):534-40. doi: 10.1097/MCG.0b013e31818c87d7.
- Background: PubMed 22525306Zanini B, Ricci C, Bandera F, Caselani F, Magni A, Laronga AM, Lanzini A; San Felice del Benaco Study Investigators. Incidence of post-infectious irritable bowel syndrome and functional intestinal disorders following a water-borne viral gastroenteritis outbreak. Am J Gastroenterol. 2012 Jun;107(6):891-9. doi: 10.1038/ajg.2012.102. Epub 2012 Apr 24.
- Background: PubMed 15740480Ji S, Park H, Lee D, Song YK, Choi JP, Lee SI. Post-infectious irritable bowel syndrome in patients with Shigella infection. J Gastroenterol Hepatol. 2005 Mar;20(3):381-6. doi: 10.1111/j.1440-1746.2005.03574.x.
- Background: PubMed 19457422Spiller R, Garsed K. Postinfectious irritable bowel syndrome. Gastroenterology. 2009 May;136(6):1979-88. doi: 10.1053/j.gastro.2009.02.074. Epub 2009 May 7.
- Background: PubMed 22777341Strate LL, Modi R, Cohen E, Spiegel BM. Diverticular disease as a chronic illness: evolving epidemiologic and clinical insights. Am J Gastroenterol. 2012 Oct;107(10):1486-93. doi: 10.1038/ajg.2012.194. Epub 2012 Jul 10.
- Background: PubMed 23524129Cohen E, Fuller G, Bolus R, Modi R, Vu M, Shahedi K, Shah R, Atia M, Kurzbard N, Sheen V, Agarwal N, Kaneshiro M, Yen L, Hodgkins P, Erder MH, Spiegel B. Increased risk for irritable bowel syndrome after acute diverticulitis. Clin Gastroenterol Hepatol. 2013 Dec;11(12):1614-9. doi: 10.1016/j.cgh.2013.03.007. Epub 2013 Mar 21.
- Background: PubMed 16741596Rafferty J, Shellito P, Hyman NH, Buie WD; Standards Committee of American Society of Colon and Rectal Surgeons. Practice parameters for sigmoid diverticulitis. Dis Colon Rectum. 2006 Jul;49(7):939-44. doi: 10.1007/s10350-006-0578-2. No abstract available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticulitis and Irritable Bowel Syndrome, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The newly developed IBS (time frame: Survey was done from 15th July 2013 to 30th September 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02003807, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2013.