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Constipation clinical trials

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NCT ID: NCT02436057 Completed - Constipation Clinical Trials

Development and Validation of the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) Platform

Start date: July 2014
Phase: N/A
Study type: Interventional

Through a four-year grant awarded to the University of California at Los Angeles in 2009, Dr. Brennan Spiegel served as a principal investigator (PI) for a project to develop and initially validate a bank of items to assess gastrointestinal (GI) symptoms for the National Institutes of Health's (NIH's) Patient Reported Outcomes Measurement Information System (PROMIS). By the end of the grant period in July 2013, the project team had successfully developed and initially validated eight scales measuring the most common GI symptoms. Afterwards, Dr. Spiegel's PROMIS team joined forces with the UCLA Computing Technology Research Laboratory (CTRL) and the University of Michigan Center for Healthcare Communication Research to develop the Automated Evaluation of Gastrointestinal Symptoms (AEGIS) algorithm which is delivered via My GI Health, an open-‐source Internet based patient-provider portal (P3) designed to enhance the delivery of GI health care (www.MyGIHealth.org). Through My GI Health and AEGIS, patients are able to complete PROMIS GI symptom measures and provide additional information about their GI symptoms and histories from computers, tablets or smart phones without the constraints of physical locale. This information is condensed into a GI PROMIS scores report and initial GI history that patients' providers can review prior to or concurrent with seeing the patient. The report, which can be incorporated into the electronic health record (EHR), helps busy clinicians to quickly understand the patient's complaints, document their symptoms and GI history, and leaves more time for conversation with the patient. Beyond focusing their interaction, My GI Health also supports both the clinician and patient with an individualized "educational prescription" which guides the patient through a library of multi‐media educational materials on GI symptoms, conditions, and treatments also contained within the website. The prescription is initially created by the website based on each patient's unique GI PROMIS "fingerprint", and can be modified by the provider based on their interaction with the patient. The clinician and patient can also access the PROMIS-tailored education in the exam room to jointly review pertinent materials, including animations of normal and abnormal GI functions, further reinforcing the patients' educational experiences around the PROMIS symptoms. The aim of this current study is to validate the use of GI PROMIS in clinical practice by conducting a pragmatic clinical trial (PCT) comparing delivery of GI PROMIS on a novel e--platform vs. usual care.

NCT ID: NCT02428790 Completed - Constipation Clinical Trials

Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury

Start date: May 2015
Phase: N/A
Study type: Observational

Empirically patients with acquired brain injury (ABI) are often constipated. This is a major clinical issue. Nevertheless, this has only been sparsely studied. The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI, and compare this to healthy controls. Secondly heart rate variability (HRV) is measured in these patients, and associations between HRV and GITT are investigated.

NCT ID: NCT02425722 Completed - Clinical trials for Chronic Constipation

A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic Constipation

Start date: April 13, 2015
Phase: Phase 2
Study type: Interventional

The objective of this study is to investigate dose-responses of efficacy and safety of ASP0456 in patients with chronic constipation (diagnosed by Rome III criteria of functional constipation (FC), not including constipation due to organic diseases) compared to placebo and to find the appropriate dose for P3 study.

NCT ID: NCT02423564 Completed - Clinical trials for Occasional Constipation

A Study Investigating the Effect of Digesta-Lac in Healthy Adults With Occasional Constipation

Start date: June 12, 2015
Phase: Phase 2
Study type: Interventional

This investigation will evaluate the effect of Digesta-Lac in adults with occasional constipation in a single-center, randomized, double-blind, placebo-controlled, parallel group 2-arm study for 3 weeks.

NCT ID: NCT02422329 Completed - Advanced Cancers Clinical Trials

Changes in Patient Reported Constipation Among Advanced Cancer Patients After Receiving an Educational Intervention

Start date: April 30, 2015
Phase: N/A
Study type: Interventional

The goal of this research study is to learn how patients' think about constipation before and after receiving education about the subject.

NCT ID: NCT02419924 Completed - Clinical trials for Pelvic Floor; Incompetency

Proof of Concept: "Bottom's Up" Seat to Treat Constipation

Start date: April 2015
Phase: N/A
Study type: Interventional

Supporting the pelvic floor can reduce symptoms of constipation in patients with refractory constipation due to pelvic floor laxity and excessive perineal descent by means of a modified toilet seat, known as "the Bottom's Up".

NCT ID: NCT02418507 Completed - Clinical trials for Functional Constipation

An Evaluation of the Effectiveness of a Proprietary Probiotic Blend on Functional Constipation

Start date: May 29, 2015
Phase: Phase 2
Study type: Interventional

The primary objective for this study is to monitor the change in patient assessed symptoms of constipation in subjects taking the proprietary probiotic blend compared to those taking the placebo. The secondary objective for this study is to additionally monitor changes in stool consistency, stool frequency, quality of life and microbial composition of feces from baseline to Day 29, in all subjects. Safety considerations monitored any changes in blood safety parameters as well as incidence of adverse events throughout the entire study for all subjects.

NCT ID: NCT02411175 Completed - Constipation Clinical Trials

The Efficacy of Individualised Homeopathic Treatment on Constipation

Start date: October 2014
Phase: Phase 2
Study type: Interventional

Constipation is an umbrella term encompassing either infrequent bowel movements, difficult evacuation of stool, hard stool or a sensation of incomplete defecation. It affects 10-15% of the global population. Constipation may negatively impact physical health, moods and social life. There exists a 50% dissatisfaction with traditional approach of laxative use. Conventional laxatives only offer a temporary solution and may cause dependency. Side-effects of conventional laxatives include nausea, vomiting, flatulence, diarrhoea, abdominal pain, electrolyte imbalance and skin eruptions. Homeopathy is a potential treatment option for constipation, however further research is needed in this regard. The aim of this study is to determine the efficacy of individualised homeopathic treatment on constipation using case studies, an adapted Bowel Function Diary and the Bristol Stool Form Scale.

NCT ID: NCT02406859 Completed - Spinal Cord Injury Clinical Trials

Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals With SCI

Start date: July 1, 2013
Phase: N/A
Study type: Interventional

An injury to the spinal cord results in a number of secondary medical problems, including the inability to voluntarily control the bowels. Depending on the severity and location of the injury, remaining bowel function differs, and can include any combination of the following: constipation (prolonged stool retention), difficulty with evacuation (difficultly moving bowels), fecal incontinence (problems retaining stool until it is appropriate to move the bowels). Most of the current medications and treatment options address problems of constipation and difficulty with evacuation, but there are few options for individuals who suffer from incontinency. In this study, the investigators propose to study, in detail, anorectal muscle function in individuals with spinal injury - the investigators will do so using new technology called high resolution manometry - which will present the investigator with a 3 dimensional representation of the pressure profile of the anorectal muscles as the subject attempts different maneuvers. A subgroup with representatives of all levels and completeness of injury and anorectal muscle function will be enrolled to participate in six weeks of biofeedback training to see if their bowel function can be improved. During these six weeks, the subjects will be asked to visit the laboratory twice a week in order to be trained by the research team on how to improve their anorectal strength and function in response to visual cues. After the six weeks, another manometry study will be performed. Subjects will then be sent home and asked to perform a series of home exercises for another 6 weeks, after which they will asked to return for a third and final manometry study.

NCT ID: NCT02387359 Completed - Clinical trials for Irritable Bowel Syndrome Characterized by Constipation

The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)

IBS-C
Start date: December 2014
Phase: Phase 3
Study type: Interventional

This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.