View clinical trials related to Functional Constipation.
Filter by:Constipation is a common disorder that globally affects 0.7% to 29.6% of children. The majority of these children receive the diagnosis of functional constipation. Functional Constipation can be challenging to diagnose and treat. The ROME IV criteria provides structure in the approach to Functional Constipation by standardizing diagnosis criteria. Functional Constipation should be suspected when a child has at least two symptoms per week for the last month consisting of: two or fewer defecations in the toilet per week, greater than or equal to 1 episode of fecal incontinence per week, history of retentive posturing or excessive volitional stool retention, history of painful or hard bowel movements, presence of a large fecal mass in the rectum, or history of large diameter stools that can obstruct the toilet. Written action plans and similar self-management tools have been associated with improved clinical and patient-reported outcomes for several pediatric chronic disease processes including anaphylaxis, asthma, and atopic dermatitis. These tools have been shown to improve patient/caregiver confidence in disease self-management at home, to increase adherence to pharmacotherapy regimens, and ultimately to enhance patient-centered outcomes. The impact of a Constipation Action Plan on Functional Constipation clinical and patient-related outcomes has not been investigated. The aim of this project was to implement and to evaluate the effectiveness of the Uniformed Services Constipation Action Plan in the management of children with Functional Constipation in a pediatric gastroenterology clinic.
Functional constipation (FC) is a common condition associated with aging, lower socioeconomic status, low physical activity and also with reduced fibre, water and magnesium intakes. Different studies have reported a positive association between the intake of hyper-mineral water containing a high content of bicarbonate, calcium, or magnesium, and the improve of the gastrointestinal transit. There is evidence that magnesium and sulphate, both individually, have a laxative action. However, the impact of other minerals is scarce. It has been described different mechanisms explaining how gut microbiota influence the gastrointestinal transit. Specifically, in FC patients, it is important to understand the particularities of their gut microbiota and understand whether the intake of hyper-mineral water, a natural source of minerals, can modify positively the gut microbiota. The aim of the present randomized placebo-controlled pilot trial is to evaluate, for the first time, the effect of the carbonated mineral water consumption in the gastrointestinal transit and in the gut microbiota of subjects with FC.
The purpose of this project is to study the the efficacy and safety of probiotics implantation through infusion during colonoscopy in the treatment of functional constipation and irritable bowel syndrome. The study is a single-center, prospective, randomized, single-blind, controlled, cohort study. The invesitigators plan to enroll 80 patients with functional constipation and 80 patients with irritable bowel syndrome. The invesitigators will randomize the included study subjects. The experimental group receive basic treatment and a single infusion of probiotics through colonoscopy. The control group receive basic treatment and a single injection of normal saline through colonoscopy. The invesitigators will follow up the patients for 8-12 weeks. The primary endpoint is the efficacy of the single colonoscopic probiotics infusion in functional constipation and irritable bowel syndrome patients. The secondary endpoint is the safety of the single colonoscopic probiotics infusion in functional constipation and irritable bowel syndrome patients. Other exploratory objectives include the alterations in clinical indicators, fecal microbiota, and intestinal microbiota metabolites in feces and serum.
This study aims to assess the clinical efficacy, safety and tolerance of a new formula containing a prebiotic and a mix of probiotics in the specific population of infants suffering from functional constipation through a superiority, double-blind, randomized, placebo-controlled trial.
conservative management of functional constipation is a preferable method including biofeedback and spinal magnetic stimulation sessions
This is a multi-center, randomized, double-blind, Placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Plecanatide in the treatment of Functional Constipation in Chinese patients for up to 12 weeks. Patients will enter a Screening period which must undergo a 2-week Pre-Treatment assessment, they will complete daily assessments of electronic dairy to demonstrate the eligibility. Eligible subjects will be randomized into Plecanatide 3 mg group or Placebo group at Visit 1 at the ratio of 1:1 and take an oral dose of study treatment continuously for 12 weeks. For 2 weeks after complete dosing patients will continue to complete daily electronic dairy. Patients will then return to the clinical site for efficacy and safety assessment as part of an End of Study visit. The planned duration of participation in this study will be 154 days and up to 164 days with all windows considered.
The study is a multi-centre, observational study which enrolls 150 IBS-C patients and 150 non-IBS-C patients in China.
This observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (FGDI)
Functional digestive pathologies are defined by symptoms such as functional dyspepsia, gastroesophageal reflux, irritable bowel syndrome, gastroesophageal reflux, functional constipation, functional diarrhea, functional bloating, the opioid-induced constipation and fecal incontinence, without organic substratum. These diseases are very common in the general population (20%) and represent the first cause of consultation in city gastroenterology. The objective of this study is to collect prospective clinical and tests data and a biological collection from biological samples collected as part of the standard care. This collection could identify diagnostic or prognostic markers of the therapeutic response.
Introduction: Constipation is one of the gastrointestinal disorders MOST frequent That Affects around 20% of the western population, being more frequent in the female gender (M1.5: H1). Constipation can be primary, When causes constipation associated With (medication, mechanical obstruction, spinal cord injury, etc.) and secondary. There are multiple therapeutic options for the management of constipation, changes in lifestyle Including, the intake of fiber, laxatives and pharmacological treatment and in selected cases (colonic inertia) surgery. The first option in the therapeutic management for Patients With constipation are changes in lifestyle, Among Which is the type of diet (increase in fiber intake, Which Has Been Associated With an improvement in the fecal matter and the evacuation frequency), liquid intake and exercise. Aim: To Evaluate the efficacy of the blue agave fructans Tequilana Weber in Patients With functional constipation Methods: This is a prospective, randomized, controlled and single blind study to determine the phase III efficacy of the blue agave fructans Tequilana Weber intake in subjects with functional constipation. In order to Achieve so, it is planned to include over 18 years of Patients age Fulfill the WHO as well as inclusion criteria The Rome III criteria for functional constipation. Statistical analysis plan: The data obtained will be analyzed with SPSS version 24. For continuous variables the results are presented in mean ± standard deviation when the variables are normally distributed or medians and percentiles otherwise and as frequency and percentages when they were categorical. For basal and subsequent comparison to the intra intervention groups, Student's t-test for paired samples (variables with normal distribution) or the Mann-Whitney U (variables without normal distribution) is used in the case of continuous variables and X2 or the McNemar test in the case of categorical variables. For comparison between groups ANOVA (variables with normal distribution) or Kruskal-Wallis (non-normal distribution variables) used for continuous variables and the same percentage of change obtained when the variables are continuous. Also an analysis of covariance (ANCOVA) was performed to control variables that might have an effect on the response variables.