The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel...
Constipation PredominantIrritable Bowel Syndrome (IBS-C)Evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern in female IBS-C patients.
Randomized Trial of Mosapride Versus Placebo in the Treatment of Constipation-Predominant Irritable...
Constipation-Predominant Irritable Bowel SyndromeThe purpose of this study is to determine whether Mosapride, an agent which acts on serotonin receptors in the gastrointestinal tract, is effective in the treatment of constipation-predominant irritable bowel syndrome (C-IBS).
Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation...
Chronic ConstipationThe purpose of this study is to determine whether ATI-7505 is effective in the treatment of chronic idiopathic constipation.
Tolerability, Safety and Efficacy of a New Frequency of Vibrant Capsule Administration
ConstipationThe study is a prospective, multicenter, open-label, single-arm study, to evaluate the tolerability, safety and efficacy of the Vibrant Capsule in relieving constipation. One arm will be assessed: Vibrant Capsule administered with a sequence of one per day for 2 days, followed by one day without, one per day for 2 days followed by one day without, etc. (14 capsules in 3 weeks). The study will have one interim analysis. Patients will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 6 weeks. Data reporting will be done on an electronic Case Report Form and an eDiary. During the 2 weeks of baseline, patients will be asked to refrain from taking any medication or supplement to relieve their constipation. After 14 days the patients will return and eligibility will be re-assessed. Patients will be trained on how to use the base unit. Patients will be instructed to complete a simple patient eDiary each day throughout the duration of the study. After 3 weeks of treatment, the patient will attend for evaluation and to receive new capsules. A final visit will take place at the end of the 6 week treatment period. Patients will receive phone calls up to twice per week and patient compliance will be monitored during the 8 weeks of the study.
Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Autistic DisorderConstipation1 moreThe clinical manifestation of autism spectrum disorder (ASD) is complex, with medical and mental health disruptions that occur with the three core behavioral criteria used for diagnosis (social behavior, communication, restricted interests/repetitive behavior). Co-occurring medical conditions, such as gastrointestinal dysfunction (GID), often are overlooked when designing research strategies to understand the mechanisms underlying the expression of ASD. This study was initially a collaboration between Children's Hospital Los Angeles (CHLA) and the Children's Hospital at Vanderbilt University. The current research project proposes to recruit subject at CHLA and the Center for Autism and Developmental Disorders (CAND), a Children's Hospital of Orange County and University of California Irvine (UCI) Health collaborative program. In Aim 1, the investigators will characterize GID in pediatric populations with ASD. Over a 12 month period, subjects will receive standard of care for their GID, typically functional constipation. The study population will be characterized with a standardized instrument for diagnosing functional GI disorders in children, the Questionnaire on Pediatric Gastrointestinal Symptoms, and with the clinical acumen of an experienced pediatric gastroenterologist. Nutritional information also will be collected to determine whether there are patterns of GIDs that correlate with dietary and nutritional status. The in-depth characterization and treatment of GIDs in children with ASD will provide a unique way of determining if ASD symptom and GID symptom improvement are related to each other. In Aim 2, the investigators will do in-depth assessment of each subjects functional status for social communication, emotional regulation, cognitive function, speech-language, sensory integration, and a biomarker of oxidative stress. The latter will be measured in urine samples over the course of one year. There are no direct interventions for autism symptoms in this study. Rather, subjects will receive standard of care for the GID diagnosis and secondary effects on ASD symptoms will be evaluated. Our power calculation shows that the investigators will be adequately powered with the proposed study design and recruitment targets. As part of the study, the investigators have developed a collaboration with investigators in the University of Southern California (USC) School of Engineering, in which the investigators will work with them to develop computational tools to assist in the characterization of videotaped Autism Diagnostic Observation Schedule (ADOS-2) assessments.
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
Opioid-Induced ConstipationThe purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC)in adults taking opioid therapy for chronic non-cancer pain.
Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety "Roll-over"...
Parkinson DiseaseConstipationThis study will be conducted as an open-label safety follow-on to a multi-center, double-blind, randomized study. All subjects who participated in the randomized study will be offered participation in this unblinded, single-arm, safety study. Approximately 50 subjects will be entered into the study and ENT-01 will be administered daily in escalating doses followed by a fixed dose for 12 weeks. Each subject will participate for approximately 20 weeks; dosing duration will be approximately 14 weeks.
26 Week Efficacy and Safety Trial for Patients With Chronic Idiopathic Constipation
Chronic Idiopathic ConstipationEfficacy and Safety Trial of elobixibat in Patients with Chronic Idiopathic Constipation treated for 26 Weeks.
Efficacy and Safety Trial of Elobixibat in Patients With Chronic Idiopathic Constipation
Chronic Idiopathic Constipation12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with Chronic Idiopathic Constipation.
The Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
Opioid-Induced ConstipationThe purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.