University of Michigan Gastroenterology: Irritable Bowel Syndrome

Irritable Bowel Syndrome

Pharmos Corporation: A double-blind, randomized, placebo-controlled phase 2b study of 100, 200, and 300 mg BID dextofisopam in female outpatients with irritable bowel syndrome (IBS)

IRB# HUM13638
Principal Invesitgator: William Chey, MD
Contact: Lina Nahlawi, phone: 734-936-2761, lnahlawi@med.umich.edu

Study Drug
Dextofisopam is the R-enantiomer of RS-tofisopam, which is approved and used outside the US for treating a variety of disorders related to autonomic dysfunction, including IBS. It acts centrally on subcortical benzodiazepine receptors, and may exert anti-inflammatory activity via cytokine inhibition. It reduces stimulated activity and decreases contractions evoked by colorectal distension.

Study Design
A 2-week treatment-free screening period, a 12-week blinded treatment period, followed by a treatment-free withdrawal period, and requires 6 visits to the research office. Study procedures include: physical exam, vital signs, lab testing, and ECG.

Compensation
$50 for each completed visit, a total of $300 for completing the whole study.

Subject Eligibility:

female age 18–65
diagnosed with diarrhea or alternating – IBS
must not have history of suicide ideation
must not have history of seizures
must not have history of head trauma with loss of consciousness
must not have psychotic disorder
BMI <40
must not have diabetes type I
must not have had an MI within the past 5 years, or significant ECG abnormalities

Prometheus Laboratories: Procurement of blood samples for use in the development of a gastrointestinal disease test panel

IRB# HUM00015569
Principal Investigator: William Chey, MD
Study Coordinator: Lina, Tel: 734.936.2761, lnahlawi@med.umich.edu

Study Objective
The objective of this study is to develop a panel of biomarkers that will assist the physician in making a diagnosis of IBS or other functional GI disorders. Serum and plasma markers will be evaluated in samples from normal controls, subjects with known IBS, subjects with functional GI disease, subjects with IBD and subjects with celiac disease.

Study Design
Approximately 1900 subjects enrolled at approximately 50 sites within the USA. Approximately 30 subjects will be enrolled at UM. The majority of subjects will be in the study for one or two doctor’s office visits. The subject will complete the questionnaire, and will give up to 30 ml non-fasting blood sample.

Subject Eligibility

Adults between 18–70 years of age.
All subjects age 50 yrs or older must have had a colonoscopy with no evidence of colon cancer. All findings must be consistent with the subject’s disease or normal control status.
No history of colorectal cancer.
Must not have diabetes (type I or type II).
Must not have a diagnosis of HIV/AIDS or chronic viral hepatitis (HAV, HBV, or HCV).
Must not have symptoms of an active ulcer or infection with Helicobacter pylori during the last 6 months.
Must not have a viral or bacterial infection or disease in the 2 weeks preceding the date of sample collection.
Must not have a diagnosis of an autoimmune disease such as rheumatoid arthritis, lupus, Parkinson’s disease, multiple sclerosis, scleroderma, or autoimmune hepatitis.
Must not have used any antibiotics in the past month

Compensation: $30

AGI Therapeutics Research Ltd: A randomized, double-blind, placebo-controlled study of AGI-003 (arverapamil) in the treatment of irritable bowel syndrome with diarrhea (IBS-D)

IRB# HUM00016350
Principal Investigator: William Chey, MD
Study Coordinator: Lina, Tel: 734.936.2761, lnahlawi@med.umich.edu

Study Objective
To determine the efficacy of AGI-003 (arverapamil) in the treatment of IBS-D during an active phase of diarrhea.

Study Drug
Arverapamil is the R(+) enantiomer of verapamil hydrochloride, which is a well established calcium channel blocker. Racemic verapamil has been reported to have beneficial effects in gastrointestinal conditions associated with diarrhea, including IBS.

Study description
This is a multicenter, randomized, double-blind, placebo-controlled, 4-parallel group trial. A total of 1200 patients will be included who meet the Rome III criteria for IBS-D. Participants will record their daily bowel habits using the IVRS. There will be a 2-week screening period followed by a 12-week treatment period during which subjects will return once a month to the research office. Study procedures include: physical exam, vital signs, ECG, and clinical lab tests.

Subject Eligibility:

Adults ages 18–70 years old
Diagnosed with diarrhea IBS
Hypotension, cardiac arrhythmias, L ventricular dysfunction
Barrett’s and/or Grade III esophagitis
Antibiotic use within one month prior to screening (prophylactic use of antibiotic is allowed if on stable dose for > 3 months)
Past or present alcohol or drug abuse.

Compensation: $25 for each visit, $125 for completing the study.