InflammationK23NCT01072903
The Role of Intestinal Inflammation in Irritable Bowel Syndrome (IBS)
An observational study of Inflammation and Colon, Irritable, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The research project addresses the following hypotheses (A) the normal balance of beneficial and detrimental commensal intestinal bacteria is deranged in IBS, with selective alterations in clinically defined patient subsets i.e., diarrhea predominant IBS (D-IBS) and post-infectious IBS (PI-IBS); (B) these changes in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Colon, Irritable, Colonic Diseases, Functional
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jul 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This research plans to study 33 diarrhea predominant Irritable Bowel Syndrome and IBS-mixed/alternators patients with current symptom activity (abdominal pain at least once a week in the past month) and 33 healthy controls. The subjects will be of any gender, race or ethnicity and at least 18 years of age. Recruitment for the proposed study takes advantage of an ongoing NIH-supported research study on the heterogeneity of IBS (NIDDK Grant DK 31369, WE Whitehead - PI, IRB#01-1397, GCRC# 1846) currently conducted at UNC.
Who may be able to join
- Any sex, race, or ethnicity.
- At least 18 years of age (no upper age limit).
- D-IBS and M-IBS patients must meet Rome II criteria for IBS and must have been evaluated by a physician to exclude alternative diseases that could explain the symptoms. For the latter, patients' self statement is acceptable (by self-report, no official document is required).
- D-IBS and M-IBS subjects older than 50 years old must have had a colonoscopy in the past 5 years with a normal report. Hemorrhoids, diverticulosis and polyps are allowed.
- Participation in Dr. Whitehead's heterogeneity of IBS research study, or Dr. Ringel's Probiotic Pain Study.
Who cannot join
- Healthy controls must have no significant or recurring gastrointestinal symptoms.
- Patients and healthy controls should not have a serious, unstable medical condition.
- Patients and healthy controls must have had no gastrointestinal tract surgery other than appendectomy or cholecystectomy, or any abdominal surgery within the past 3 months. Appendectomy and cholecystectomy are allowed if done more than 2 years ago and symptoms were not changed following the surgery.
- Pregnancy and breastfeeding (by self-report).
- No history of inflammatory bowel diseases, celiac disease, or other diagnosis that could explain chronic or recurring bowel symptoms in IBS patients or controls (by self-report).
- Patients and controls should have no history of lactose malabsorption (by self-report).
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- Patients and controls should have no history of clinical symptoms of acute infections during the last 8 weeks prior to enrollment in the study.
- Patients and controls should have no history of anti-inflammatory agents including aspirin, non-aspirin, non-steroid anti-inflammatory (NSAID), steroids, antibiotic, or probiotics treatment during the last 4 weeks prior to enrollment in the study.
- Patients should not have an implanted or portable electro-mechanical medical device such as a pacemaker and/or other implanted stimulators or pumps.
- Evidence of acute inflammation on routine histology.
- Evidence of enteric pathogens on routine stool cultures.
- Presence of a medical condition that requires routine use of antibiotic treatment with dental or other invasive procedures (by self-report).
- To be confirmed at time of screening and the week of the flexible sigmoidoscopy appointment for IBS-M subjects ONLY: In the past week, subject cannot have less than 3 (0-2) bowel movements. Also, in the past week, subject cannot have hard/lumpy stools for 2 or more days.
- Only subjects with IBS may participate in the optional SmartPill testing. Subjects are excluded from SmartPill testing if a subject has:
- A history of gastric bezoar.
- Suspected strictures, fistulas, colon cancer or other physiological GI obstruction.
- Dysphagia.
- Diverticulitis.
- Tobacco use within eight hours prior to capsule ingestion and during the initial 8 hour recording on Day 0 or the Ingestion visit.
- Alcohol use within eight hours prior to capsule ingestion and throughout the entire monitoring period (5 days).
- Body Mass Index > 40 kg/m2.
- Female of childbearing age who is not practicing birth control and/or are pregnant or lactating.
- Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.
- A medical device such as a pacemaker, infusion pump, or insulin pump.
- Any contraindication to use of Fleets Enema or the balloon expulsion test.
- Uncontrolled diabetes with a hemoglobin A1C greater than 10.
- Allergies to any of the ingredients of the standard SmartBar meal
- Subject plans to take any of the following prohibited medications: Medication to alter gastric pH, Medication that affect GI motility for 3 full days before the start of the study and during the ensuing days of study, Medication for nausea and vomiting that block serotonin receptors, Anti-diarrheal agents, Opiate agents used to treat diarrhea, Non-steroidal anti-inflammatory drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill, Program in Digestive Health and the Department of Gastroenterology and Hepatology
Chapel Hill, North Carolina, 27599-7080
About this study
Official title: The Role of Intestinal Inflammation in the Pathophysiology of IBS
The research project addresses the following hypotheses (A) the normal balance of beneficial and detrimental commensal intestinal bacteria is deranged in IBS, with selective alterations in clinically defined patient subsets i.e., diarrhea predominant IBS (D-IBS) and post-infectious IBS (PI-IBS); (B) these changes in intestinal microflora are associated with sub-clinical mucosal inflammation and activation of the mucosal immune system; and (C) activation of the mucosal immune system leads to alterations in gastrointestinal (GI) functions (i.e., motility and sensation) and functional symptoms.
Read the detailed description
There are two main aims in the research study. The first aim is to determine whether sub-clinical mucosal inflammation occurs in patients with D-IBS by identifying alterations in mucosal markers for inflammation (inflammatory cytokines and inflammation-related mediators). The second aim is to investigate whether the identifiable alterations in inflammatory markers are associated with specific abnormalities in intestinal motor and sensory functions that are relevant to the pathophysiology of IBS.
- Keywords
- inflammation, colon, irritable, Colonic Diseases, Functional, Irritable Bowel Syndrome
- Medical subject headings
- Inflammation, Irritable Bowel Syndrome, Colonic Diseases, Functional
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 |
|---|---|---|
| IBS | Subjects with IBS | |
| Healthy | Healthy Controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startJan 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yehuda Ringel, University of North Carolina, Chapel Hill
- Investigators
- Yehuda Ringel, MD, Principal investigator, UNC Chapel Hill Department of Gastroenterology and Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072903
- Sponsor's protocol ID
- 08-1106
- Other IDs
- K23DK075621
- Acronym
- K23
- Status last verified
- Dec 2013
- First submitted
- 18 Feb 2010
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ringel Y, Carroll IM. Alterations in the intestinal microbiota and functional bowel symptoms. Gastrointest Endosc Clin N Am. 2009 Jan;19(1):141-50, vii. doi: 10.1016/j.giec.2008.12.004.
PubMed 19232285Ringel Y, Drossman DA. Irritable bowel syndrome: classification and conceptualization. J Clin Gastroenterol. 2002 Jul;35(1 Suppl):S7-10. doi: 10.1097/00004836-200207001-00003.
PubMed 12184143
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intestinal Inflammation in the Pathophysiology of IBS
- ClinicalTrials.gov ID
- NCT01072903
- Acronym / sponsor ID
- K23 / 08-1106
- Keywords
- inflammation, colon, irritable, Colonic Diseases, Functional, Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Feb 2010 (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 research project addresses the following hypotheses (A) the normal balance of beneficial and detrimental commensal intestinal bacteria is deranged in IBS, with selective alterations in clinically defined patient subsets i.e., diarrhea predominant IBS (D-IBS) and post-infectious IBS (PI-IBS); (B) these changes in intestinal microflora are associated with sub-clinical mucosal inflammation and activation of the mucosal immune system; and (C) activation of the mucosal immune system leads to alterations in gastrointestinal (GI) functions (i.e., motility and sensation) and functional symptoms.
Detailed description
There are two main aims in the research study. The first aim is to determine whether sub-clinical mucosal inflammation occurs in patients with D-IBS by identifying alterations in mucosal markers for inflammation (inflammatory cytokines and inflammation-related mediators). The second aim is to investigate whether the identifiable alterations in inflammatory markers are associated with specific abnormalities in intestinal motor and sensory functions that are relevant to the pathophysiology of IBS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBS | – | –Subjects with IBS |
| Healthy | – | –Healthy Controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This research plans to study 33 diarrhea predominant Irritable Bowel Syndrome and IBS-mixed/alternators patients with current symptom activity (abdominal pain at least once a week in the past month) and 33 healthy controls. The subjects will be of any gender, race or ethnicity and at least 18 years of age. Recruitment for the proposed study takes advantage of an ongoing NIH-supported research study on the heterogeneity of IBS (NIDDK Grant DK 31369, WE Whitehead - PI, IRB#01-1397, GCRC# 1846) currently conducted at UNC.
Key inclusion criteria (5 listed)
- Any sex, race, or ethnicity.
- At least 18 years of age (no upper age limit).
- D-IBS and M-IBS patients must meet Rome II criteria for IBS and must have been evaluated by a physician to exclude alternative diseases that could explain the symptoms. For the latter, patients' self statement is acceptable (by self-report, no official document is required).
- D-IBS and M-IBS subjects older than 50 years old must have had a colonoscopy in the past 5 years with a normal report. Hemorrhoids, diverticulosis and polyps are allowed.
- Participation in Dr. Whitehead's heterogeneity of IBS research study, or Dr. Ringel's Probiotic Pain Study.
Key exclusion criteria (28 listed)
- Healthy controls must have no significant or recurring gastrointestinal symptoms.
- Patients and healthy controls should not have a serious, unstable medical condition.
- Patients and healthy controls must have had no gastrointestinal tract surgery other than appendectomy or cholecystectomy, or any abdominal surgery within the past 3 months. Appendectomy and cholecystectomy are allowed if done more than 2 years ago and symptoms were not changed following the surgery.
- Pregnancy and breastfeeding (by self-report).
- No history of inflammatory bowel diseases, celiac disease, or other diagnosis that could explain chronic or recurring bowel symptoms in IBS patients or controls (by self-report).
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
Not reported in the source record.
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 12 Dec 2013.
- Background: PubMed 19232285Ringel Y, Carroll IM. Alterations in the intestinal microbiota and functional bowel symptoms. Gastrointest Endosc Clin N Am. 2009 Jan;19(1):141-50, vii. doi: 10.1016/j.giec.2008.12.004.
- Background: PubMed 12184143Ringel Y, Drossman DA. Irritable bowel syndrome: classification and conceptualization. J Clin Gastroenterol. 2002 Jul;35(1 Suppl):S7-10. doi: 10.1097/00004836-200207001-00003.
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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.
Yehuda Ringel, MD principal investigator
UNC Chapel Hill Department of Gastroenterology and Hepatology
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 Inflammation and Colon, Irritable, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 5 inclusion and 28 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 12 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01072903, which also lists 2 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 12 Dec 2013.