Irritable Bowel Syndrome (IBS)
A 26-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of tenapanor for the treatment of constipation-predominant irritable bowel syndrome (IBS-C)
This study will compare the safety and effectiveness of an investigational drug for IBS-C.
The study is seeking adults with IBS-C whose abdominal discomfort and constipation are not well controlled. After a 2-week screening period during which the severity of symptoms will be assessed and eligibility determined, patients will be randomized to receive the study drug tenapanor or placebo. Treatment lasts 26 weeks. In addition, clinical blood tests, EKG, physical examination, and vitals will be collected before and after randomization.
For each subject, the entire study will last 28 weeks; this includes 26 weeks of treatment, preceded by a 2-week screening period. It will require a total of 9 visits.The proposed mechanism of action of tenapanor is to reduce Na+ re-uptake. This decrease in Na+ uptake increases the net fluid volume in the gastrointestinal tract. Restoration of normal luminal fluid content facilitates intestinal transit and stimulates motility.
- Adults between 18–75 years with constipation-predominant IBS.
- Female childbearing potential: must not be pregnant, and must use reliable contraception method throughout the study
- Must have colonoscopy within 10 years if subject 50 years or older
- Must not have cancer, inflammatory bowel disease, diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, pancreatitis (within 12 months of screening), cholelithiasis, amyloidosis, ileus, non-controlled GERD, gastrointestinal obstruction, or carcinoid syndrome.
- Must not have a CNS cause of constipation (e.g., Parkinson’s disease, spinal cord injury, or multiple sclerosis)
- Must not use medications that are known to affect stool consistency; accepted are stable, continuous regimen of fiber, bulk laxatives, stool softeners, or probiotics
- Must not have prior bowel resection (accepted is appendectomy, cholecystectomy, polypectomy)
- Must not have a major psychiatric disorder that has required hospitalization in the last 3 years, or history of attempted suicide or uncontrolled bipolar disorder
- Must not have abused alcohol or other substance in the last year
- Must not have chronic kidney, heart, or lung disease that may prevent study completion
- Must not have a history or current evidence of laxative abuse
Compensation: $75 for each completed visit; a total of $675
Expected Recruitment End Date: November 2016
Principal Investigator: William Chey, MD
Study Coordinator: Lina email: LNahlawi@med.umich.edu, Telephone: (734) 936-2761
Probe-based confocal laser endomicroscopy to detect structural and functional duodenal mucosal abnormalities in patients with functional dyspepsia (FD): Understanding the mechanisms generating symptoms in functional dyspepsia
The lining of the small bowel will be evaluated at microscopic level in individuals with symptomatic functional dyspepsia (FD) and healthy individuals without gastrointestinal symptoms using the confocal laser endomicroscopy (CLE) technique, which is applied through a routine upper endoscopy (esophagogastroduodenoscopy [EGD]). CLE is a new technique capable of dynamic visualization of architectural changes of the gut mucosa at a microscopic level.
The study is seeking two types of participants: FD group and healthy subjects group. Study will require 2 visits over a period of 2 to 4 weeks. First visit subjects will be screened to determine eligibility and consent. Participants with FD will go through a 2-week screening period, during which the severity of their dyspeptic symptoms will be assessed and eligibility determined. All eligible subjects will undergo an EGD with CLE on visit 2. Healthy subjects will have the EGD procedure at no cost to them, but FD subjects will be responsible for the EGD procedure charges.
- Subjects 18 years of age or older
- Female subjects must not be pregnant and must use a reliable contraception method
- Must not be on a special or restricted diet (e.g., gluten-free, lactose-free, or low FODMAP)
- Must not have recent weight loss, family history of gastrointestinal cancer, or worsening swallowing problems
- Must not have uncontrolled reflux disease (e.g., frequent heartburn with regurgitation, chronic cough) or active gallbladder disease
- Must not be taking antiinflammatory drugs (like Motrin, Ibuprofen, Advil, Aspirin)
- Must not have history of peptic ulcer disease or erosive esophagitis
- Must not have inflammatory bowel disease, small intestinal bacterial overgrowth, gastrointestinal bleeding, or pancreatitis
- Must not have any medical condition known to affect the gastrointestinal system (e.g., scleroderma, unstable thyroid disease, uncontrolled diabetes mellitus), cancer, severe kidney or liver disease
- Must not have history of previous surgery in the gastrointestinal tract, except appendectomy or cholecystectomy if performed more than 6 months prior to participating in the study
Healthy subjects must have no current or past history of gastrointestinal disease.
FD subjects must have at least one of the following symptoms of indigestion for at least 6 months duration:
- Belly pain or burning
- Feeling full shortly after eating
- Inability to finish a normal sized meal
Expected Recruitment End Date: November 2017
Principal Investigator: Borko Nojkov, MD
Study Coordinator: Lina email: LNahlawi@med.umich.edu, Telephone: (734) 936-2761
A study to compare the use of two different diets to reduce or improve loose stools or bowel incontinence
This study will compare two diets to see which one is more effective in improving or eliminating accidental bowel leakage (which is also called fecal incontinence). One diet is using foods that are low in fermentable carbohydrates and the other diet is using foods high in fiber.
Study patients will be in the study for six weeks and will be expected to come to the investigator’s office for 4 visits, each visit lasting 1-2 hours. Subjects will be asked to record symptoms daily during the 6 weeks. This will take approximately 5 minutes per day. Patients will be given dietary counseling for 4 weeks to asses if diet can help control the symptoms they are experiencing.
Responsibilities as a study patient will include the following:
- Follow all directions given by the study staff including dietary directions
- Report the intake of all medications
- Tell the doctor about any adverse effects you have had since your last visit
- Tell the study doctor if you plan to have surgery, other medical treatment, or a medical procedure during the study
- Make no changes in your diet or lifestyle other than those specifically outlined in the study
The first two weeks, study patients will record symptoms daily to see if they will qualify for the study. The last 4 weeks, patients will be on the study diet and will record symptoms daily.
At the end of the study, study patients will be offered additional diet counseling for the alternate diet.
Follow-up survey (optional)
This study is looking for patients who are experiencing fecal incontinence, bowel leakage, loose stool or other issues of bowel control.
- This study is seeking 18 years or older male and female patients with functional fecal incontinence.
- Must have loose bowels
- Must not be pregnant
- Must not have cognitive dysfunction or be unable to understand or provide written informed consent
- Must not have inflammatory bowel disease
- Must not have a disease known to affect the gastrointestinal system (i.e., scleroderma, unstable thyroid disease, etc.)
- Must not have severe kidney or liver disease
- Must not have had previous abdominal surgery, other than appendectomy, cholecystectomy, and gynecologic/urologic surgery if performed more than six months before enrollment
- Must not be taking certain medications such as probiotics, antibiotics, and narcotics
Expected Recruitment End Date: December 2017
Principal Investigator: Stacy Menees, MD
Study Coordinator: Naoshin Khan email: firstname.lastname@example.org, Telephone: (734) 936-1989