201 Clinical Trials for Various Conditions
This study will serve as a pilot randomized controlled trial to assess the feasibility of Psilocybin-Assisted Psychotherapy (PAP) in Treating Irritable Bowel Syndrome (IBS). Patients with severe IBS will undergo 3 pre-psychotherapy sessions with two licensed and trained psychedelic therapists, then will be randomized to undergo a guided psychotherapy session with single 25 mg oral "high" dose of psilocybin or a single 100 mg dose of niacin (active placebo) and attend 4 post-therapy integration sessions.
IBS - Irritable Bowel Syndrome
Participants with IBS (all subtypes) and with no exclusionary comorbid psychiatric or medical disorders will be enrolled in the study. This study will involve a randomized waitlist control design to investigate the rapid and sustained effects of TRP-8802 following two experimental sessions in which an oral dose of TRP-8802 is administered to participants with IBS. The study will include clinician and participant ratings of depression and anxiety pre- and post-drug-session, monitor and participant ratings of subjective drug effects during and after each drug session. This study comprises approximately a 28-day screening period (Days 28 to 1). After screening and enrollment, participants will be randomized to an immediate treatment group or a delayed treatment group ("waitlist control" condition). Participants in the immediate treatment group will proceed directly into three weeks of baseline and preparation (Days 1 to 18), a 2-dose administration period (Days 22 and 37), integration (Days 23, 30, 38, and 45), the End of Therapy (EOT) visit (Day 52). Participants in the delayed treatment group will wait 8 weeks after enrollment before beginning the study interventions and neuroimaging assessments. As a safety precaution, participants in the delayed treatment group will be assessed weekly via telephone calls or in-person visits during the wait period (i.e., telephone assessments during post-randomization weeks 1, 2, 3, 4, 5, 6, and 7; in-person assessment during post-randomization week 8) to assess suicide risk to determine if intervention is warranted. During week 8, IBS symptoms will also be assessed. At the end of the delay period, all participants in the delayed treatment group will complete the same intervention as the participants in the immediate treatment group. Validated and commonly used assessment tools will be used to evaluate symptoms at baseline and repeatedly after each session. The weekly average of worst daily pain score and weekly stool frequency and consistency for the 7 days immediately prior to EOT visit will be assessed for change from baseline and at the 3-, 6 , and 12- month follow-up visits (Days 120, 240, 365).
Irritable Bowel Syndrome
This study is being completed to determine if the Mediterranean (MD) and low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diets are comparable in the effectiveness to treat Irritable Bowel Syndrome (IBS). The study team hypothesizes that: * The low FODMAP and Mediterranean groups will achieve a similar improvement in abdominal pain * Both groups will achieve similar improvements in bloating, overall IBS symptom severity, and adequate relief
Irritable Bowel Syndrome
A three month follow-up study to evaluate the effectiveness of a tailored anti-inflammatory eating plan guided by a registered dietitian to treat irritable bowel syndrome.
IBS - Irritable Bowel Syndrome
Viome costumers are consented and recruited for this study and complete the questionnaires upon enrollment. Any participant who previously self reported depression, anxiety, or Irritable Bowel Syndrome (IBS) qualify for this study. All participants receive Viome's diet, supplement and recommendations.
Depression, Anxiety, IBS - Irritable Bowel Syndrome
This study is being conducted to evaluate in participants with diarrhea-predominant Irritable Bowel Syndrome (IBS-D) the abdominal pain response to BOS-589 after 4 weeks of treatment and to evaluate the overall safety and tolerability of BOS-589 in the treatment of IBS-D during 4 weeks of treatment, relative to placebo (PBO).
Diarrhea-predominant Irritable Bowel Syndrome
This is a pilot study to determine the efficacy of the Stress Management and Resilience Training (SMART) program in improving gastrointestinal and psychological symptoms, health-related quality of life, and satisfaction of care in patients with irritable bowel syndrome (IBS). Half of the participants will be enrolled in the SMART program initially. The other half will be placed in a self-management stress reduction program where they will read a popular stress reduction book over 12 weeks. Then they will have access to participate in the online SMART program.
Irritable Bowel Syndrome
This is a randomized, double-blind, placebo-controlled, 2-arm parallel group study. After qualifying for the study and signing informed consent, patients will undergo a two-week observation period during which stool consistency and frequency data and symptom data will be collected. Patients will then be randomized 60:40 to RHB-102 12 mg (BEKINDA) or placebo. Patients will continue on treatment for 8 weeks. Each medication will be given once daily.
Irritable Bowel Syndrome With Diarrhea
The purpose of this project is to examine whether a low cost, group-oriented integrative medicine approach to irritable bowel syndrome improves participant outcomes. The intervention will combine nutrition counseling on the low FODMAP diet (decreased grains and other disaccharides) and mind-body training with follow-up health coaching. These participants will be randomized to either a 4-week group-oriented treatment intervention incorporating a low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet and mind-body therapies followed by an 8-week health coaching follow-up period or a waitlist control group. At the end of the 12-week study period, waitlist subjects will be offered the four-week nutrition and mind-body intervention. Over the 12-week study period, we will examine and report on the impact of this treatment intervention on IBS symptoms and quality of life in this population. The investigators will collect data on IBS outcomes as well as on depression and stress.
Irritable Bowel Syndrome, IBS
This phase 2, randomized, double blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of three dose levels of AZD1722 in subjects with constipation predominant IBS (IBS-C) as defined by the ROME III criteria and who have active disease as determined during a two-week screening period. Subjects who qualify and are randomized into the study will receive 5, 20, or 50 mg of AZD1722 BID or placebo BID for 12 consecutive weeks. At the end of this treatment period, subjects will be followed for an additional 4 weeks.
Constipation Predominant Irritable Bowel Syndrome
This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4 weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D over the 4-week treatment period.
Diarrhea Predominant Irritable Bowel Syndrome
The purpose of this study is to compare the effects of 5g of Daikenchuto (TU-100) three times per day (Daikenchuto \[TU-100\] 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.
Irritable Bowel Syndrome, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Abdominal Pain
The objective is to evaluate whether ONO-2952 modulates visceral pain perception produced by rectal distention in female patients with IBS-D
Irritable Bowel Syndrome (IBS)
The objective of this study is to explore efficacy, safety and tolerability of ONO-2952 in female subjects with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D).
Irritable Bowel Syndrome (IBS)
The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.
Irritable Bowel Syndrome
The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.
Irritable Bowel Syndrome
Purpose: The investigators are proposing to examine the use of Savella® (Milnacipran) for treating irritable bowel syndrome (IBS) in women. Participants: Eligible participants will meet the Rome III diagnostic criteria for IBS. Procedures: This study will observe patients treated with Savella® as well as patients treated with a placebo (pill with no active drug). The investigators will monitor and compare several patient and symptom related outcomes, as well as evaluate health related quality of life, psychological distress and related psychosocial measures to determine if the addition of Savella® improves clinical pain response as well as secondary outcomes including quality of life.
Irritable Bowel Syndrome
This is a multi-center, Phase 2, randomized, double-blind, placebo controlled study of RDX5791 in subjects with IBS-C. Patients who are 18 to 75 years old, meeting the definition of IBS-C as defined by the Rome III Criteria for the Diagnosis of IBS will undergo a battery of screening procedures to determine eligibility for the trial. The study will consist of a 2-week treatment-free screening period, a 4-week blinded treatment period, and a 2-week treatment-free follow-up period.
Constipation Predominant Irritable Bowel Syndrome
Primary Objective: • To confirm the efficacy of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in the improvement of symptoms in adult patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and functional dyspepsia Secondary Objective: • To confirm the safety of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in adult patients with IBS-D and functional dyspepsia
IBS-D and Functional Dyspepsia
An observational study to evaluate LOTRONEX® in women with severe IBS-D in the current clinical practice setting.
Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. There are still no effective and safe medications approved for the treatment of abdominal pain associated with bowel symptoms in IBS. This study will investigate the effects of an approved medication, Dronabinol, on the movement of food through the stomach and colon in subjects with a history of diarrhea-predominant Irritable Bowel Syndrome (D-IBS). Dronabinol is a synthetic medication (a medication made in a laboratory) related to the active ingredient of "cannabinoid or marijuana". Dronabinol is approved by the Food and Drug Administration (FDA) for preventing nausea and vomiting in patients with cancers undergoing chemotherapy. It is also used in AIDS patients with excessive weight loss for improvement in appetite and weight gain. The hypothesis in this study is that dronabinol will slow down the movement of food through the colon, and that this effect is regulated by the genes controlling the body messengers (receptors) that respond to medicinal marijuana or synthetic medicines that work on the same messengers that are present in the gastrointestinal tract and pain nerves.
Irritable Bowel Syndrome
The purpose of this study is to determine the daily dose of mesalamine granules that will provide adequate relief from symptoms of IBS with diarrhea.
Irritable Bowel Syndrome With Diarrhea
Irritable bowel syndrome (IBS) is a common disorder which presents with abdominal pain or discomfort in association with altered bowel habit. IBS is further subcategorized as three types according to the predominant bowel movement pattern: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), and mixed-IBS (IBS-M). The exact causes of IBS remain incompletely understood, but proposed mechanisms include abnormal motility, visceral hypersensitivity, abnormal brain-gut interactions, psychological distress, and altered GI tract motility. Lubiprostone, a novel drug that works by activating the colonic Chloride channel type 2(ClC-2), has been approved for use in patients with chronic idiopathic constipation and recently approved for the treatment of IBS-C in women aged 18 and older. By activating the ClC-2 chloride channel in the colon, lubiprostone allows more fluid secretion into the intestinal lumen which leads to softer stool consistency. In phase III clinical trials, patients with IBS-C receiving lubiprostone have reported improvements in many symptoms such as abdominal pain and constipation. However, there is limited physiologic data to explain how exactly lubiprostone improves IBS-C symptoms. The Smartpill is a novel non-digestible capsule that is capable of measuring intraluminal pH, pressure, and temperature in the gastrointestinal (GI) tract. Smartpill has been shown to accurately measure whole gut as well as regional (i.e. stomach, small bowel, colon) transit time. The primary aim of this study is to determine the effects of lubiprostone on whole GI tract transit, colonic transit, motility, and intraluminal pH in patients with IBS-C through evaluation with the Smartpill. The investigators propose to study the effect of lubiprostone vs. placebo on these parameters, and secondarily to evaluate changes in these parameters with differing doses of lubiprostone. The investigators hypothesize that lubiprostone will increase whole GI and colonic transit compared to placebo in patient with IBS. the investigators do not expect a change in intraluminal pH with lubiprostone compared to placebo.
Irritable Bowel Syndrome, Constipation
The proposed pilot project for this seed grant focuses on the role of intestinal serine-proteases in the pathogenesis of diarrhea-predominant IBS (D-IBS). In this study we will further assess serine-protease activity in patients with D-IBS and also explore a possible mechanism by which these proteases can lead to alterations in intestinal physiology and symptoms in these patients. The general hypotheses for the proposed research are that (A) the levels of fecal serine-protease in patients with D-IBS are abnormally increased (B) this abnormal serine-protease activity leads to/is associated with an abnormal increase in intestinal permeability and therefore enables (C) chronic stimulation and activation of the mucosal immune system in these patients. In addition, it is aim to determine whither periodontal inflammation is associated with intestinal permeability and serine protease activity.
Colon, Irritable
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.
Inflammation, Colon, Irritable, Colonic Diseases, Functional, Irritable Bowel Syndrome
Irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.
Irritable Bowel Syndrome
The objective of this study is to test the efficacy of a symptom management treatment strategy, namely, Acupuncture/Moxibustion (Acu/Moxa) to improve the symptoms associated with Irritable Bowel Syndrome (IBS) in persons between the ages of 18 to 70 years. IBS has been defined as abdominal pain or discomfort in the mid or lower gastrointestinal (GI) tract, associated with defecation or a change in bowel patterns and with features of disordered defecation. Current therapies include dietary modification, psychotherapy and pharmacological therapies. Traditional eastern approaches offer a therapeutic approach to symptom management that is subtle, holistic and holds promise as an intervention for IBS. This study will enroll 171 men and women experiencing IBS with diarrhea (IBS-D) defined by the ROME III criteria. Subjects will be randomized (by chance) to one of three experimental intervention conditions: Condition 1,subjects receive Standard Acu/Moxa; Condition 2, subjects receive Individualized Acu/Moxa and Condition 3, subjects receive Sham Acupuncture/Placebo Moxibustion(control group). Subjects will attend a screening/intake session followed by two treatment sessions per week for 4 weeks, one treatment session per week for 4 weeks, and 2 non-treatment follow-up sessions at weeks 12 and 24. All subjects will be assessed by a diagnostic acupuncturist (blinded to treatment assignments), receive interventions appropriate to their condition assignment by treating acupuncturists, be administered the same instruments, and submit their symptom diaries for data entry and analysis. All subjects will complete a prospective symptom diary for the duration of the study.
Irritable Bowel Syndrome
The aim of this study is test the efficacy of a comprehensive self-management therapy to decrease abdominal pain/discomfort and improve quality of life in patients with irritable bowel syndrome (IBS) compared to IBS patients receiving their usual care.
Irritable Bowel Syndrome
Individuals with irritable bowel syndrome (IBS) may experience abdominal pain as a result of pain signals in the bowel and how these signals are processed in the brain. Studies using brain imaging (pictures) have shown that IBS patients with more pain diagnoses (i.e. fibromyalgia, migraines, etc.) have greater activity in the regions of the brain responsible for the emotional and thought processing of pain signals. This could possibly make bowel sensations and bowel difficulties feel abnormal or more noticeable, in turn causing more severe IBS symptoms. The purpose of this protocol is to explore the role of pain diagnoses and their affect on brain activity in IBS patients. The investigators will also examine the use of a medication, desipramine, which is known to affect these brain regions, in IBS patients.
Irritable Bowel Syndrome
Objective: Randomized, double blind, placebo-controlled, crossover, clinical trial to examine the effects of the food additive glutamate (in the form of MSG) on IBS and fibromyalgia. Setting and Subjects: The Fibromyalgia Research Database at OHSU will be utilized to identify and recruit fibromyalgia patients who also have IBS to OHSU study centers. Intervention: Approximately 60 male and female subjects aged 18-75 will be placed on a 1-month glutamate-free elimination diet. Those that respond positively to the diet (we are estimating 30-40 subjects), will then be randomized to receive either a citrus drink containing 5 grams of MSG; or placebo (the citrus drink alone)on three consecutive days one week apart. The investigators are hypothesizing that those who react positively to the elimination diet will have symptom occurrence statistically more frequently when given the glutamate challenge, than when given placebo.
Irritable Bowel Syndrome, Fibromyalgia