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Active clinical trials for "Irritable Bowel Syndrome"

Results 251-260 of 880

SH-DS01 on Fecal Metagenomic Stability

Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disorder that generates a significant health care burden and is the most commonly diagnosed gastrointestinal condition. Nearly 12% of all patients in the United States seek medical care in primary care practice for IBS and it accounts for 3.1 million ambulatory care visits and 5.9 million prescriptions annually. The pathophysiology of IBS is distinctly broad compared to other gastrointestinal conditions and includes abnormalities involving motility, visceral sensation, brain-gut interaction, and distress. Though patients with IBS often have a heterogeneous symptom profile, the predominant theme is the presence of abdominal pain or discomfort that is usually relieved by defecation. Host factors such as genetics, immune function, and psychological status, as well as environmental factors such as stress, recent infection, or treatment with antibiotics, could predispose to the development of chronic IBS symptoms. Due to a myriad of contributing factors, a single cause of IBS remains enigmatic. Despite the urgent need to develop better therapies, the high range of placebo response has made clinical trials challenging, ranging from 16.0 to 71.4% with a population-weighted average of 40.2%. Recent studies have also shown alterations in gut immune response, and a disrupted intestinal and colonic microbiome in association with IBS. The current working hypothesis is that abnormal microbiota activate mucosal innate immune responses, which increase epithelial permeability, activate nociceptive sensory pathways, and dysregulate the enteric nervous system. Targeting the microbiota and gastrointestinal tract with live organisms is a promising approach, yet previous trials have yielded limited success due to empiric strain selection, small population size, and inadequate trial design to control for a high placebo response. This protocol aims to assess the impact of a multi-strain consortia of 24 commensal organisms across 12 species with extensive strain-specific in vivo data, assessing a range of gastrointestinal symptoms without negatively altering the naive gut microbiota. High-throughput shotgun DNA sequencing will provide opportunity for '-omics'-based analyses of the gut microbiota, which can be augmented by the metabolite profiles resulting from total microbial activity in the gut. Since many of these metabolites are bioeffector molecules acting upon the host, such analysis can provide a direct measure of the consequences of microbial activity in the gut and provide a novel integrated data set for patients with IBS. Recruited subjects will also use a smart-phone application to report day to day gastrointestinal symptoms, a patient-centric hallmark of this chronic gut condition. Probiotics are live microorganisms with a vast array of therapeutic potential for gastrointestinal disease. Several probiotics strains have shown beneficial outcomes in constipation-predominant IBS (IBS-C) patients, especially as an adjunct to conventional treatment. However, a number of controversial issues regarding the roles of probiotics in pathogenesis of IBS-C remain to be clarified, including precise mechanism of action. This protocol aims to assess the impact of a mix of 24-beneficial strains on individual gastrointestinal symptoms specifically in a cohort of subjects with IBS-C or IBS-M.

Completed32 enrollment criteria

Comparison of the Effects of Different Nutrition Treatments on Patients With Irritable Bowel Syndrome...

Irritable Bowel Syndrome

Irritable Bowel Syndrome (IBS) is a disease associated with changes in bowel habits characterized by unexplained abdominal discomfort or pain. Common symptoms of the disease include gas, bloating, diarrhea, constipation, and common gastrointestinal problems associated with psychosocial problems. IBS makes it difficult for patients to attend school and work, reduce productivity, increase healthcare costs and negatively affect quality of life. Although IBS is not a life-threatening disease, it is a condition that must be tackled throughout life. The disease is clinically managed through dietary interventions and appropriate lifestyle changes, and pharmacological symptom-targeted or psychological treatments. The aim of this study is to determine the effects of different dietary treatment methods on patients 'severity symptom score and quality of life, and the patients' compliance with different dietary treatments.

Completed12 enrollment criteria

Analysis of Microbiota Changes Induced by Microencapsulated Sodium Butyrate in Patients With Inflammatory...

Inflammatory Bowel DiseasesIrritable Bowel Syndrome

Inflammatory bowel disease (IBD) is characterized by severe inflammation of the small bowel and/or the colon leading to recurrent diarrhea and abdominal pain. Irritable Bowel Syndrome with diarrhea (IBS-D) is characterized by abdominal pain or discomfort, gas, loose and frequent stools. Butyrate has shown anti-inflammatory and regenerative properties, providing symptomatic relief when orally supplemented in patients suffering from various colonic diseases. The investigator proposes to investigate the effect of a microencapsulated form of sodium butyrate on the fecal microbiota of patients with IBD and IBS-D.

Completed6 enrollment criteria

qQ-lab Daily-IBS for Irritable Bowel Syndrome

Irritable Bowel Syndrome (IBS)

Primary purpose: To assess satisfaction with overall improvement in symptoms, including individual bowel symptoms, after 4 weeks of administration of gQ-lab to patients with irritable bowel syndrome (IBS). Secondary purposes: To assess the correlation between intestinal attachment and therapeutic effects of gQ-lab through the visual analog scale (VAS) assessment of each IBS-related symptom and measurement of changes in quality of life and fecal flora in the placebo group and gQ-lab group after 4 weeks of gQ-lab administration. To assess safety, including adverse reactions, vital signs (including weight), physical examination, and changes in blood test results. To examine the rate of positive gut quotient (gQ) values in patients diagnosed with IBS as per the ROME III criteria. Further, to examine how the ROME III-based symptom scale score compared with that of the quality of life scale in the gQ questionnaire.

Completed22 enrollment criteria

The Efficacy and Safety of "BST104" (Lonicera Flos Extract) in Mild to Moderate Functional Dyspepsia...

Functional DyspepsiaIrritable Bowel Syndrome

This study was conducted to prove the efficacy of BST-104 in patients with mild to moderate FD.

Completed14 enrollment criteria

Study to Evaluate the Effect of Pasteurized Akkermansia Muciniphila (pAkk) on Complaints Related...

Irritable Bowel Syndrome

Double-blind, randomised, placebo-controlled study to evaluate the benefit of pasteurized Akkermansia muciniphila in reducing complaints related to irritable bowel syndrome. Further objectives are to evaluate the beneficial potential of pAkk on any anxiety and depression complaints, as well as its safety and tolerability.

Completed45 enrollment criteria

Low FODMAP Diet in Patients With IBS

Irritable Bowel Syndrome

We aimed to investigate if all carbohydrate groups eliminated in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS. in a randomised cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for three months without wash-out-periods. Gastrointestinal symptoms, Quality of life was measured at baseline and after each intervention diet.

Completed1 enrollment criteria

Alcat Based Elimination Diet for the Treatment of Irritable Bowel Syndrome; a Randomized Double...

IBS - Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is the most common GI condition with global prevalence ranging between 10-20%. Although the exact cause is not known there are increasing insights concerning the possible multifactorial etiology including low grade inflammation, neuromodulation, dysbiosis, impaired integrity of the intestinal barrier and more. Currently, it is believed that changes in the microbiota may activate mucosal innate immune responses, resulting in increased epithelial permeability, activated nociceptive sensory pathways, and dysregulation of the enteric nervous system. Nearly two thirds of patients with IBS perceive their GI symptoms to be food related, hence, food intolerance may be important factor in the pathogenesis. Diet is a part of IBS treatment but adherence, on the one hand, and restriction, on the other, remain a major problem. [Chey WD, Am J Gastroenterol,2016]. Confocal laser endomicroscopy (CLE) is a technique that permits real-time detection and quantification of changes in intestinal tissues and cells, including increases in intraepithelial lymphocytes and fluid extravasation through epithelial leaks. Based on CLE analysis of IBS patients with a suspected food intolerance, exposure to candidate food antigens caused immediate breaks, increased intervillous spaces, and increased IELs in the intestinal mucosa. These changes are associated with patient responses to exclusion diets. [Fritscher-Ravens A et al, Gastroenterology. 2019, Gastroenterology. 2014] This technic, also efficient according to former studies, is costly and invasive. The Alcat Test is a lab based immune stimulation test in which a patient's WBC's (white blood cell) are challenged with various substances including foods, additives, colorings, chemicals, medicinal herbs, functional foods, molds and pharmaceutical compounds. The Alcat Test objectively classifies a patient's response to each test substance as reactive, borderline or non-reactive. Based on these classifications, a customized elimination/rotation diet may be designed.

Completed11 enrollment criteria

Effect of taVNS on Abdominal Pain and Other Symptoms in Constipation-predominant Irritable Bowel...

Constipation-predominant Irritable Bowel SyndromeAbdominal Pain

This study aims to investigate the effects and possible mechanisms of transcutaneous auricular vagal nerve stimulation (taVNS) on abdominal pain and other symptoms in patients with IBS-C.

Completed10 enrollment criteria

Assessment of Psychological Symptoms and Health Related Quality of Life in Patients With Irritable...

IBS - Irritable Bowel Syndrome

To evaluate the relation between the clinical presentations and the psychiatric co-morbidities with the quality of life in patients with irritable bowel syndrome.

Not yet recruiting4 enrollment criteria
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