Michael Camilleri, M.D., D.Sc.

The purpose of this study is to evaluate the effects of tradipitant relative to placebo in healthy volunteers:

• Difference in fasting GV;
• Difference in postprandial GV and in accommodation volume (that is, postprandial minus fasting gastric volumes);
• Difference in gastric emptying (T1/2, emptying at 2h and emptying at 4h);
• Volume to fullness (sensation of usual postprandial fullness) and maximum feeling of fullness (MTV).

The specific aim of this study is to compare simultaneous assessment of gastric emptying and gastric accommodation in response to the same caloric meal before and three months after activation of left cervical VNS.  Our hypothesis is that cervical VNS increases gastric accommodation and accelerates gastric emptying.

The primary aim of this study is to evaluate the efficacy of rimegepant on abdominal pain scores in participants with non-constipation IBS.

The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.

The purpose of this study is to evaluate the dose-dependent effects of TAK-954 on gastric emptying time of solids in participants with diabetic or idiopathic gastroparesis assessed by scintigraphy.

The purpose of this study is to determine whether LJN452 improves the symptoms of bile acid diarrhea and to assess its safety and tolerability profile in patients with primary bile acid diarrhea (pBAD) to guide decision-making regarding further clinical development in this indication.

This is a study intended to evaluate the effectiveness and safety of the vibrating capsule device versus a sham non-vibrating capsule on spontaneous bowel movement, to aid the relief of constipated individuals.

The purpose of this study is to evaluate safety and tolerability as well as the effects of RM-131 on colonic transit, bowel consistency, bowel habits, abdominal pain, and other abdominal symptoms in patients with chronic constipation.

This will be a single-center, randomized, parallel group, multiple dose administration, double-blind, placebo-controlled study to evaluate the effects of YKP10811 on gastric, small bowel, and colonic transit in patients with Chronic Constipation or Functional Constipation. Four groups including a placebo group will be enrolled and will receive multiple oral doses of YKP10811 or matching placebo.

The primary aim of this pilot and feasibility, hypothesis-generating study therefore is to evaluate the effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham endoscopic surgery on symptoms in patients with diabetic or idiopathic gastroparesis.

Gastroparesis is a disorder of gastric function characterized by delay in gastric emptying, frequently associated with chronic nausea and vomiting, early satiety, postprandial fullness, abdominal pain, and malnutrition that may require nutritional support. There are few effective treatments available; more recently, a procedure called G-POEM (gastric peroral endoscopic myotomy) has been advocated to relieve symptoms by improving gastric emptying; however, it is not clear whether this is safe or effective.

The purpose of this study is to demonstrate reduced intestinal permeability after 3 weeks of BB01 (20g of BB01, which reflects 15g of insoluble dietary fiber) consumption in a group of 10 patients with IBS-diarrhea with evidence of bile acid diarrhea, a group that has been previously documented to have increased GI permeability.

To understand the mechanisms associated with diarrhea in patients receiving conditioning chemotherapy prior to autologous stem cell transplantation and to test the effects of the studied therapies on mechanisms that may be involved in the pathophysiology of diarrhea associated with conditioning chemotherapy.

The purpose of this study is to evaluate the effects of relamorelin (RM-131) on gastric volume, motor and sensory effects in healthy patients.

This research study is being done to compare the effects of Aprepitant and placebo on fasting gastric volume, accommodation volume, satiation (fullness) and gastric emptying.

The purpose of this study is to evaluate safety and tolerability as well as the effects of RM-131 on colonic motor and sensory effects in patients with chronic constipation.

The investigators' hypothesis is that therapy with Colesevelam, reduces fecal bile acid excretion in patients with IBS-diarrhea with prior evidence of increased fecal 48 hour total bile acid excretion. The investigators aim to study the ability of the HPLC assay for fecal bile acids to demonstrate responsiveness after treatment with Colesevelam.

Investigator plans to examine the gastrointestinal (GI) physiologic profile of Teduglutide, a Glucagon-like Peptide 2 Analog as a possible intestinotrophic growth factor capable of inducing small bowel adaptation and regeneration in patients with short bowel syndrome (SBS), with the potential to decrease parenteral nutrition dependence.

The purpose of this study is to evaluate the changes in bowel movements in patients with multiple myeloma receiving conditioning cheomotherapy for autologous stem cell transplantation (SCT). 

This study is being done to evaluate the safety and effects of Food and Drug Administration (FDA) approved medication, Eluxadoline, on bowel function in study participants with IBS-D who do or do not have bile acid malabsorption (BAM). Eluxadoline has been approved by the FDA for people with IBS-D but it is not known whether it will work the same way in people with IBS-D who also have BAM.

To evaluate the safety and effectiveness of oral nutritional therapy Serum-Derived Bovine Immunoglobulin (SBI) on nutritional status, epithelial barrier function, and mucosal expression of pivotal genes including tight junction, secretory mechanisms, tissue repair proteins and chemokines in subjects with IBS-D.

The purpose of this study is to understand the role of genetics (inherited genes from biological parents) and expression of genes and proteins in the lining of the intestine and colon in the development of diarrhea in patients with irritable bowel syndrome with or without bile acid malabsorption. 

The purpose of this study is to conduct a study of the effects of orally administered Castor oil on small bowel and colonic permeability measured in healthy female and male adults.

The purpose of this study is to compare the effects of 5g of TU-100 three times per day (TU-100 is a botanical agent that modulates gastrointestinal nerves), and placebo on rectal sensation (sensation ratings of urgency to defecate and sensation threshold for pain) in response to rectal balloon distension by barostat in patients with IBS.

This study will evaluate whether bile acids are able to increase insulin sensitivity and enhance glycemic control in T2DM patients, as well as exploring the mechanisms that enhance glycemic control. These observations will provide the preliminary data for proposing future therapeutic as well as further mechanistic studies of the role of bile acids in the control of glycemia in T2DM.

The purpose of this study is to evaluate the effects of methylnaltrexone  on movement of solids through the digestive tract in healthy human subjects.

The purpose of this study is to evaluate gastric, small-bowel, and colonic transit in subjects with IBS-C and IBS-D treated with multiple (three times daily) doses of olorinab (50 mg).

The purpose of this study is to evaluate the effects of pregabalin, a drug approved for anticonvulsive therapy and for neuropathic pain, on colonic and sensory functions in healthy individuals.

The purpose of this study is to evaluate the effects of an investigational (not yet FDA approved) medication, ROSE-010, on the movement of food through the stomach, small intestine and colon in females who have a  constipation predominant form of irritable bowel syndrome.

The purpose of this study is to compare the effects of secretin vs. saline on satiation, fasting gastric volume, gastric accommodation and emptying, and symptoms in patients with functional dyspepsia with normal gastric emptying and with that of healthy volunteers.

Investigators are doing this research study to find out the effect of T6 dermatomal electrical stimulation (delivered by a Transcutaneous Electrical Nerve Stimulation (TENS) unit) on appetite and weight loss.

The investigators are doing this research study to find out the effect of T6 Dermatomal Electrical Stimulation (delivered by a Transcutaneous Electrical Nerve Stimulation (TENS) unit) on stomach motor activity.

The Vibrant Capsule is a novel vibrating device for the treatment of gastrointestinal disorders. The effect of different vibrations on the motor functions of the gastrointestinal tract are unclear. The study will focus on the stomach in healthy volunteers. The study will compare the effects of Vibrant Capsule treatment and a sham capsule treatment on gastric emptying and gastric motility in healthy volunteers.

The purpose of this study is to evaluate the effects of A3309 on gastric, intestinal and colon transit in patients who have functional constipation.

The purpose of this placebo-controlled parallel group clinical study in healthy adults from the general population aims to investigate whether oral supplementation with S. boulardii could strengthen the intestinal barrier function and counteract the acute NSAID-induced hyperpermeability (i.e., indomethacin), using the in vivo multi-sugar permeability test. Furthermore, inflammatory status, self-reported health and gut microbiota composition, will be assessed.

The purpose of this study is to establish a new protocol and normative values for evaluating gastric emptying and accommodation in bariatric surgery patients.

The purpose of this study is to test gluten supplementation for four weeks, to see if it increases small intestinal permeability and accelerates colonic transit in patients who have irritable bowel syndrome with diarrhea (IBS-D) or functional diarrhea (FD) who are HLA-DQ2 positive.

The goal of this project, to develop a simple and sensitive test of small bowel permeability, will improve the scientific and public health understanding of environmental enteropathy and guide development of preventative and treatment modalities such as clean water and sanitation.

The purpose of this study is to measure small intestinal and colonic permeability in 20 patients with active Inflammatory Bowel Disease (IBD), 20 patients with IBD in remission, and to compare with already acquired data from 60 healthy controls.

A subsidiary aim is to acquire new data in 20 healthy controls in order to ensure that the measurements of intestinal and colonic permeability in this cohort are consistent with those previously acquired in 60 healthy controls whose diet was standardized by meals prepared by the diet kitchen.

The purpose of this research is to establish the normal range of diameter and distensibility of pylorus and the fasting and postprandial antro-pyloric motility in healthy male and female adults.

Our overall goal is to determine the effect of Phentermine and Topiramate on gastric emptying, gastric accommodation, and satiety and satiation in obese participants.

The purpose of this study is to to evaluate the effectiveness and safety of cannabidiol for gastroparesis and functional dyspepsia.

Obesity is associated with differences in stomach function, feeling of fullness after meals, and total calories consumed at a buffet meal. Based upon previous research, our study hypothesis is that weight loss with pharmacological agents may be individualized, based on the abnormality in those gastrointestinal functions. These studies will provide support for the principle that specific obesity medications should be selected according to individual characteristics, and it is anticipated that this approach will enhance the effectiveness of medication treatment of obesity.

The purpose of this study is to assess how common bile acid malabsorption is in patients that have diarrhea predominant irritable bowel syndrome, by measuring blood samples for bile acids and abnormal levels of regulating hormones.

To compare with a randomized trial (n=15 per treatment group), effects of colesevelam and placebo treatment, on colonic transit, bowel functions, permeability and tight junction expression in rectosigmoid mucosa of IBS-D with Bile Acid Malabsorption.

We aim to validate fasting serum C4 and primary bile acids from a single stool sample (individually or in combination) in 65 patients with diarrhea predominant irritable bowel syndrome (IBS-D), 30 healthy volunteers, and 12 patients with terminal ileal resection > 10 cm. First, we will validate the combined serum C4 and primary bile acids in patients with IBS-D without BAM, IBS-D with BAM, and healthy volunteers by comparing the individual or combined serum and stool test to documented 48 hour total fecal bile acid (current gold standard to diagnose bile acid malabsorption in the USA). Second, we will evaluate the utility of combined serum and blood test in patients with ileal resection > 10 cm, compared to data prospectively collected from healthy volunteers.

The primary purpose of this study is to obtain normative data (median, 10th and 90th percentile), as well as inter-individual coefficient of variation (COV, assessed by [SD/mean]) with approximately 15 participants in each age group: 18-30, 31-45, 46-60, and 60-70 years old.

The purpose of this study is to determine the effect of NGM282 on colonic transit, bile acid homeostasis, and fecal fat in subjects with functional constipation and in healthy individuals.