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Constipation clinical trials

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NCT ID: NCT03047629 Completed - Parkinson's Disease Clinical Trials

Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related Constipation

RASMET
Start date: May 11, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2a study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of an orally-administered medication to relieve symptoms of constipation associated with Parkinson's Disease. Ten patients will be enrolled in Phase 1, and will be studied over an 8-12 week period. Forty patients will be enrolled in Phase 2, and will be studied over an 8-10 week period. All subjects will receive the study drug during one of the observational periods of the study.

NCT ID: NCT03046563 Enrolling by invitation - Constipation Clinical Trials

The Applying of Acupressure and Abdominal Massage to Improving Constipation in Stroke Patients.

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

Experimental research design with two-group repeated-measure design. Experimental group was pressing the Hegu (LI 4), Zusanli (ST 36) , Tianshu(ST 25) and abdominal massage for eight minutes total, press once in the morning and afternoon, seven days total and two days for follow the trail. Control group was pressing sham ponits. Research tools to self semi-structured questionnaire collected data on patient's diet, activity, medication, defecation patterns, subjective defecation feelingauscultation bowel sounds like.

NCT ID: NCT03031977 Completed - Clinical trials for Stroke Rehabilitation

Visceral Mobilization and Functional Constipation in Stroke Survivors

Start date: September 2016
Phase: N/A
Study type: Interventional

The aim of the present study was to evaluate the effect of visceral mobilization on symptoms of functional constipation and static balance in stroke survivors.

NCT ID: NCT03031301 Recruiting - Constipation Clinical Trials

A Study to Assess the Efficacy and Safety of the Vibrant Capsule Administered 5 Times Per Week

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

The study is a prospective, adaptive, multicenter, randomized, double-blind, Sham-controlled study, to evaluate the efficacy and safety of the Vibrant Capsule in relieving constipation in subjects with functional constipation. Two arms will be assessed: - Vibrant Capsule administered 5 times per week - Sham Capsule administered 5 times per week Subjects will follow a 2 weeks baseline period and then take the Vibrant Capsule for a treatment period of 8 weeks. Data reporting will be done on an electronic Case Report Form (eCRF) and an eDiary. Subjects will be asked to refrain from taking any medication or supplement to relieve their constipation, during the entire study period. After the 14 days of run-in period, the subjects will return and eligibility will be re-assessed. Subjects will be trained on how to use the base unit and will swallow the first capsule on site the day of baseline visit. They will activate and ingest the rest of the capsules at home by themselves, using the base unit. Subjects will be instructed to complete a simple subject eDiary each day throughout the duration of the study. A final visit will take place at the end of the 8 week treatment period. Subjects will receive phone calls at least once a week and subject compliance will be monitored during the 8 weeks of the study.

NCT ID: NCT03030664 Completed - Constipation Clinical Trials

Effect of L. Reuteri on Bowel Movements in Children (BIOWELL Study)

BIOWELL
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

A randomized, multicenter, placebo-controlled, double blind study in two parallel groups testing the efficacy of daily oral supplementation with the probiotic L.reuteri DSM17938 compared to placebo in increasing the number of spontaneous bowel movements in infants and children with functional constipation.

NCT ID: NCT03018613 Recruiting - Clinical trials for Fecal Microbiota Transplantation

Fecal Microbiota Transplantation for Chronic Functional Constipation

FMTFCFC
Start date: July 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Chronic functional constipation is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of chronic functional constipation is closely related to imbalance of intestinal flora .Moreover,types and quantity of intestinal flora may be related to intestinal motility. Fecal microbiota transplantation as a new technology to rebuild intestinal flora has been used for several disease,but the clinical efficacy of chronic functional constipation by fecal microbiota transplantation needs to be further explored.

NCT ID: NCT02984969 Recruiting - Clinical trials for Slow Transit Constipation

Using 16S rRNA Gene Sequencing Analysis Intestinal Microbiota in Constipation Patients

Start date: July 2016
Phase: N/A
Study type: Observational

Constipation is a frequent, chronic gastroenterological problem that has many varied symptoms and thus has several clinical definitions. According to the Rome III criteria for chronic constipation, almost 16% of all adults are affected by chronic constipation worldwide, and it is more prevalent and symptomatic in women and elderly people. Slow transit constipation (STC) is the major category and is characterized by a decreased rate of colonic transit. Recently, many researchers have focused on the relationship between intestinal microbiota and constipation and have demonstrated that intestinal microbiota contribute to the pathophysiology of functional gastrointestinal disorders. Thus, there is a need for an improved understanding of gut microbiota composition in constipation patients and for the potential role played by the gut microbiota in the etiology of STC.To achieve this goal the investigators characterized and compared the intestinal microbiota among carefully selected patients with constipation that were clinically categorized based on Rome III criteria, and healthy controls using high throughput pyrosequencing of the 16S rRNA gene and a conservative approach to detect quantitative changes in the relative abundances of taxa.

NCT ID: NCT02977858 Completed - Constipation Clinical Trials

ISE to Support Constipation Management

Start date: August 30, 2016
Phase:
Study type: Observational

This study is a single site prospective controlled trial assessing two educational interventions designed to educate local pediatric Primary Care Physicians (PCP) and nurses on collaboratively developed treatment guidelines for pediatric constipation. The study aims to assess the impact of an Spaced Education game to aid the implementation of the management guideline. PCP adherence to recommended treatment will be assessed in addition to PCP satisfaction with the educational methods, constipation knowledge and patient outcomes.

NCT ID: NCT02977286 Terminated - Constipation Clinical Trials

Naloxegol to Prevent Lower Gastrointestinal Paralysis in Critically Ill Adults Administered Opioids

Start date: January 1, 2017
Phase: Phase 4
Study type: Interventional

This study evaluates the addition of naloxegol (Movantik) to a laxative protocol in critically ill adults requiring scheduled opioid (e.g. fentanyl) therapy. Half of the participants will receive naloxegol and a laxative protocol and half the participants will receive a placebo and a laxative protocol.

NCT ID: NCT02961582 Completed - Surgery Clinical Trials

Effectiveness and Cost-effectiveness of Sacral Neuromodulation in Patients With Idiopathic Slow-transit Constipation

Start date: February 21, 2017
Phase: N/A
Study type: Interventional

Rationale: Previous reviews showed that the evidence regarding the effectiveness of sacral neuromodulation (SNM) in patients with therapy-resistant, idiopathic (slow-transit) constipation is of suboptimal quality. Furthermore, there is no estimate of costs and cost-effectiveness in this patient group. Objective: The main objective of this study is to assess the effectiveness of SNM compared to personalized conservative treatment (PCT), in patients with idiopathic slow-transit constipation who are refractory to conservative treatment. The secondary objectives are assessing the 1) costs, 2) cost-effectiveness and 3) budget-impact of SNM compared to PCT. Hypothesis: Based on previous research we hypothesize that SNM will be more effective than PCT in terms of a significantly higher proportion of patients having treatment success at 6 months. Study design: An open-label pragmatic randomized controlled trial (RCT) combined with a prospective cohort study. Study population: Adolescent (14-17 years) and adult (18-80 years) patients with idiopathic slow-transit constipation refractory to conservative treatment. Intervention: The intervention is SNM, a minimally invasive surgical procedure consisting of two phases. In the screening phase an electrode is inserted near the third sacral nerve and connected to an external stimulator. If the screening phase is successful (average defecation frequency (DF) ≥3 a week), the electrode is connected to a pacemaker that is implanted in the buttocks of the patient. If not successful, patients receive conservative treatment. The control intervention is PCT. This is the best and least invasive alternative to SNM. PCT consists of medication and/or retrograde colonic irrigation. Main study parameters/endpoints: The primary outcome is success at 6 months, defined as an average DF of ≥3 a week according to a 3-week defecation diary. Secondary outcomes are straining, sense of incomplete evacuation, constipation severity, fatigue, constipation specific and generic (health-related) quality of life ((HR)QOL), and costs at 6 months. Furthermore, cost-effectiveness and budget-impact will be estimated.