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Anorectal Pressures and Simultaneous Dynamic Imaging
Rochester, Minn.
Many people have constipation because they cannot defecate. However, we do not fully understand the mechanisms of normal defecation or constipation. We are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.
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Effect of Cholecystokinin (CCK) on Gastroduodenal Activity in Humans
Rochester, Minn.
The purpose of this research study to compare the effects a hormone cholecystokinin (CCK) in the bloodstream in healthy people and in patients with rapid gastric emptying. CCK regulates (controls) the rate at which food empties from the stomach into the small intestine. We want to learn how CCK affects the activity of the stomach and small intestines in patients with rapid gastric emptying. We are also trying to learn if genes regulate the effects of CCK.
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Effect of Improving Glycemic Control on Gastric Emptying in Type 1 and Type 2 Diabetes Mellitus
Rochester, Minn.
The purpose of this study is to evaluate the effects of improving glycemic control, and/or reducing glycemic variability on gastric emptying, intestinal barrier function, autonomic nerve functions, and epigenetic changes in subjects with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) who are switched to intensive insulin therapy as part of clinical practice.
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Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia
Rochester, Minn.
The purpose of this study is to understand why patients with indigestion, with or without diabetes, have gastrointestinal symptoms and, in particular, to understand where the symptoms are related to increased sensitivity to nutrients.Subsequently, look at the effects of Ondansetron on these patients' symptoms.
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Symptoms During a Gastric Emptying Study
Rochester, Minn.
To understand the utility of measuring stomach emptying, symptoms during a stomach emptying, and blood markers of body metabolism.
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Understanding Mechanisms of Normal and Disordered Defecation
Rochester, Minn.
The purpose of this study is to compare rectal emptying and rectoanal pressures in healthy people and DD. Our hypotheses are that (i) the rate and amount of rectal emptying is higher in healthy people than in patients with DD, (ii) some patients with symptoms of DD will have a normal balloon expulsion test but reduced rectal emptying measured with fecomanoflowmetry, and (iii) compared to healthy people, the rectal pressure increment and/or anal relaxation is reduced in patients with DD.
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Understanding Mechanisms of Normal and Disordered Defecation with Functional Magnetic Resonance Imaging (fMRI MD)
Rochester, Minn.
The objective of this study is to compare the central neural circuitry with fMRI (7T) in 30 asymptomatic healthy controls, 30 constipated patients without DD, and 30 constipated patients with DD at rest (functional connectivity analysis), during rectal distention to desire to defecate and urgency, and during evacuation.
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Use of a Squatting Assist Device in Patients with Constipation
Rochester, Minn.
Constipation is a very common problem. Western style toilets that are nearly universal in the United States require the person to sit on the toilet. However, results from uncontrolled studies suggests that a squatting posture (as prevalent in many foreign countries) may be better at facilitating evacuation compared to a Western style commode. One uncontrolled, unpublished study suggests that a footstool improved bowel symptoms in nearly 98% of 153 constipated participants. The purpose of this study is to evaluate the benefits of a footstool on symptoms and anorectal function in constipated patients.
Closed for Enrollment
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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2a Study of Oral IW-9179 Administered Once and Twice Daily for 4 Weeks to Patients With Diabetic Gastroparesis
Rochester, Minn.
The objectives of this study are to evaluate the safety of IW-9179 in patients with diabetic gastroparesis (DGP) and the effect of treatment on the cardinal symptoms of DGP.
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A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients with Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
Rochester, Minn.
The purpose of this study is to evaluate the effects of multiple dose regimens of RM-131 on vomiting episodes, stomach emptying and stomach paralysis symptoms in patients with Type 1 and Type 2 diabetes and gastroparesis.
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A Placebo Controlled Study of Colesevelam in Fecal Incontinence
Rochester, Minn.
The purpose of this study is to compare the effects of a combination of colesevelam and clonidine to a placebo on bowel symptoms in patients with urge or combined type fecal incontinence.
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Abdominal Wall Motion in Normal and Disordered Defecation
Rochester, Minn.
The purpose of this study is to assess abdominal wall contractions at rest, during maneuvers which activate the abdominal wall, and during simulated rectal evacuation in healthy women and patients with disordered defecation.
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Assessment of a New Technique to Assess Anal Pressures by Manometry
Rochester, Minn.
The specific aims of this study are to measure recto-anal pressures measured by portable manometry at rest, during squeeze, during simulated evacuation, rectal distention, and during a Valsalva maneuver in asymptomatic healthy women and men.
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Assessment of Defecation by MRI
Rochester, Minn.
The purpose of this study is to explain the mechanisms of impaired rectal evacuation characterizing phenotypes in functional defecation disorders, and ascertain if pelvic floor retraining can be tailored to underlying mechanisms.
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Comparative Effectiveness of Biofeedback, Sacral Nerve Stimulation, and Injectable Bulking Agents for Treatment of Fecal Incontinence: The Fecal Incontinence Treatment (FIT) Study (FIT)
Rochester, Minn.
The objectives of this study are effectiveness in reducing the frequency of fecal incontinence (FI) per week, safety measured by the number of adverse events, and cost of delivering each of the treatments (Biofeedback, Sacral Nerve Stimulation, and Injectable Bulking Agents).
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Effects of Alpha-1 Antagonists, Stress and Relaxation on Anal Pressures
Rochester, Minn.
This study is designed to better understand the effects of effects of stress, relaxation, and a medication alfuzosin on bowel control and emptying in healthy people and patients with bowel problems. Normally, bowel emptying requires relaxation of the anal sphincter (i.e., lowermost end of intestinal tract) and pelvic muscles. Some people cannot relax these muscles normally and experience constipation. Alfuzosin is a medication which is approved to treat bladder but not bowel problems.
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Effects of the Minnesota Medical Technologies Anal Insert Device in Fecal Incontinence
Rochester, Minn.
The primary purpose of this study is to evaluate the effectiveness of the Minnesota Medical Technologies (MMT) anal insert device on fecal continence over 3 months in patients with fecal incontinence (FI).
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Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus
Rochester, Minn.
To understand why patients with indigestion with or without diabetes have gastrointestinal symptoms and in particular to understand where the symptoms are related to increased sensitivity to nutrients.
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Improving Anorectal Testing for Defecatory Disorders and Fecal Incontinence
Rochester, Minn.
The purpose of this study is to better understand the mechanisms by which people retain control of their bowel contents and evacuate stool (defecation) and why people have constipation or fecal incontinence (involuntary stool leakage). Pressure measurements (by manometry) and magnetic resonance imaging (MRI) are widely used for diagnosis in patients with constipation or fecal incontinence. This study is trying to improve the utility of these tests for diagnosing these problems and to understand if pressure measurements (by manometry) can be related to strength of the anal sphincter measured by MRI. To do this, we will study the effects of alfuzosin on these muscles.
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Modulation of Heme Oxygenase 1 by Nizatidine and Lisinopril in Healthy Subjects
Rochester, Minn.
To assess if oral nizatidine or lisinopril alone and in combination will increase heme oxygenase 1 (HO-1) protein concentration and activity compared to placebo in healthy subjects.
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Reproducibility of Assessing Gastric Emptying by Scintigraphy in Patients
Rochester, Minn.
The purpose of this study is to understand the day-to-day variability in stomach emptying and gastrointestinal (GI) transit in patients with digestive symptoms. This information will be useful for interpreting the results of stomach emptying studies in future.
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Single-cell Gastric Epigenomics and Transcriptomics in Humans
Rochester, Minn.
The purpose of this study is to improve our understanding of why gastrointestinal symptoms occur in diabetes mellitus patients and identify new treatment(s) in the future.
These symptoms are often distressing and may impair glycemic control. We do not understand how diabetes mellitus affects the GI tracy. In 45 patients undergoing sleeve gastrectomy, we plan to compare the cellular composition of circulating peripheral mononuclear cells, stomach immune cells, and interstitial cells of Cajal in the stomach.
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Utility of Pharmacogenomic Testing in Patients with Gastrointestinal Disorders
Rochester, Minn.
The purpose of this study is to:
- To evaluate the pharmacogenomic profile (PGx) by genotyping 22 genes, including the CYP2D6 genotype, in patients with functional GI disorders.
- To assess the impact of PGx testing on prescriber patterns in this practice.
- To explore the impact of PGx testing on patient outcomes after an assessment in this practice.
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Validating Bowel Diaries
Rochester, Minn.
This study will validate a bowel diary to be used for a forthcoming study comparing effectiveness of biofeedback, sacral nerve stimulation, and injectable bulking agents for the treatment of fecal incontinence (FI).
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