The Role of Intestinal Inflammation in Irritable Bowel Syndrome (IBS)

NCT01072903 | Completed

• 2 other identifiers: 08-1106K23DK075621
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Inflammation; Colon, Irritable; Colonic Diseases, Functional; Irritable Bowel Syndrome

Keywords

inflammation; colon, irritable; Colonic Diseases, Functional; Irritable Bowel Syndrome

Study Arms (2)

IBS

Subjects with IBS

Healthy

Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill, Program in Digestive Health and the Department of Gastroenterology and Hepatology

Chapel Hill, North Carolina, 27599-7080, United States

Location

Related Publications (2)

• 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.

  PMID: 19232285 BACKGROUND

• Ringel 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.

  PMID: 12184143 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

8 rectosigmoidal intestinal biopsies, stool, and blood

MeSH Terms

Conditions

Inflammation; Irritable Bowel Syndrome; Colonic Diseases, Functional

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Yehuda Ringel, MD

  UNC Chapel Hill Department of Gastroenterology and Hepatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 22, 2010
• Study Start: January 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

US (1)