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49 active trials for Constipation

S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis

This phase II trial studies how well isatuximab works in treating patients with primary amyloidosis that has come back or does not respond to treatment. Monoclonal antibodies, such as isatuximab, may interfere with the ability of cancer cells to grow and spread.

Start: March 2018

Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation

This study intends to evaluate the effects of three prebiotic solid beverages (mainly dietary fiber and prebiotics) and one probiotic solid beverage on the laxative effect of patients with functional constipation through randomized controlled trials. The influence of tract flora is expected to provide a basis for related therapies for patients with functional constipation.

Start: August 2020

A Study of Lubiprostone to Treat Constipation

The main aim of this study is to check the side effects from lubiprostone in adults with constipation. Participants will be treated with lubiprostone according to their clinic's standard practice.

Start: June 2021

Misoprostol for Bloating and Distension

Symptoms of bloating, abdominal distension, and constipation are common in patients with cirrhosis. These symptoms may be explained by disease-associated effects in gastrointestinal physiology, as well as medication side-effects. The presence of these symptoms affect quality of life, as well as risk for encephalopathy. Misoprostol is a synthetic prostaglandin approved for the treatment prevention of NSAID-induced gastric ulcers. The drug also causes smooth muscle contraction in the gastrointestinal tract has been shown to improve colonic motility. This study aims to assess the efficacy of misoprostol for treating bloating, distension, and constipation in patients with cirrhosis. Study participants will receive misoprostol for a duration of three days. Participants will complete pre-intervention and post-intervention symptom questionnaires and low dose abdominal computed tomography (CT) scan. These measures will be used to assess subjective symptom scores and objective measurement of intestinal gas and colonic stool. Post-intervention measures will be compared to pre-intervention measures to assess improvement of symptoms.

Start: July 2021

Effect of Preoperative Fiber on Postoperative Bowel Function

Post-operative constipation is one of the most common complaints after pelvic organ prolapse surgery. Psyillum fiber is an FDA-approved, over the counter dietary supplement that is commonly used to treat constipation. We are conducting this study to determine if individuals who receive psyllium fiber before surgery have less difficulty with their first bowel movement after surgery.

Start: May 2019

The Effects of Enzyme-rich Malt Extract on Chronic Constipation

Participants with constipation will take enzyme-rich malt extract for 4 weeks whilst completing a daily bowel habit diary before and during intervention.

Start: March 2021

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

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.

Start: March 2017

Effect of Probiotic on Constipation in Patients With Parkinson's Disease

The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis ®duo) effect on constipation and on neuropsychological performance

Start: May 2019

Nutrition to Relieve IBS Constipation

Rationale: Irritable Bowel Syndrome (IBS) is a disease that affects a large number of people. To date, no adequate treatment is available. This is partially due to the heterogeneity of the patients and the complicated pathology in which not all mechanisms are understood. Based on results of in vitro screening within the IBSQUtrition project, we selected promising dietary supplements for validation of their potential beneficial effects on stool pattern in IBS-Constipation (IBS-C) patients. Objective: The primary objective is to determine the effects of a 4-week intervention with either a prebiotic supplement (Inavea pure acacia) or a probiotic supplement (Bifidobacterium lactis BLa80) on stool pattern (including stool frequency, consistency, and volume) in IBS-C patients. The secondary objective is to determine the effects if this intervention on GI complaints and quality of life in IBS-C patients. Study design: A double-blind, randomized, placebo-controlled trial will be conducted with three parallel intervention arms Study population: 180 adult (18-70 yrs) IBS patients with a constipation-predominant subtype Intervention: A 4 week run-in period will be followed by a 4-week intervention period with three parallel arms: 1) prebiotic supplement (Inavea pure acacia), 2) probiotic supplement (B. lactis), and 3) Placebo supplement (Maltodextrin control), during which the study participants consume the respective supplement twice per day. Main study parameters/endpoints: The primary study parameter is stool pattern: stool frequency, stool consistency; and stool volume. The secondary study parameters are gastrointestinal complaints, Quality of Life, and HADS. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Study participants have to invest about 14.5 hours of their time in this study mainly to complete several questionnaires (short daily questionnaire, longer questionnaires at three occasions), which is conveniently all possible from home. They have to comply to consume a supplement twice daily for four weeks. At two time points they have to collect their stool for five consecutive days. There are limited risks for the study participants.

Start: March 2021

A Pilot Study to Explore the Role of Gut Flora in Chronic Constipation

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding chronic constipation

Start: March 2020

Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial

Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease.

Start: November 2019

Tolerability and Functional Assessment of a Novel Children's Synbiotic

Recent data support the use of specific probiotic strains in a pediatric population. However, given the wide number of commercial products available, and contradictory data in the literature, healthcare providers and consumers are uncertain about whether or not to use probiotics in children and which one(s) to choose. While much progress has been made in understanding the gastrointestinal microbiota and its role in the balanced development of the infant immune system, the tolerability and efficacy of introducing beneficial microbes into the pediatric gastrointestinal tract remain underexplored. The purpose of this study is to investigate the effect of a 9 strain synbiotic consortium comprised of strains with previous pediatric clinical data for use in modulating airway sensitivity, gastrointestinal discomfort, dermatological inflammation, and reduction in the duration and severity of upper respiratory tract infections in a pediatric population.

Start: August 2020

Studies in Patients With Defecatory Disorders

Defecatory disorders like chronic constipation and faecal incontinence affect 25% of the population with rising incidence. Defecatory disorders pose a major health care burden and are poorly recognized and treated. The need for better diagnostics and therapeutics is substantial. Current assessment of patients with constipation and faecal incontinence include endoscopic assessment to rule out intraluminal organic cause for patients' symptoms, endoanal ultrasound scan / MRI to assess patients' pelvic floor anatomy and anorectal manometry and balloon expulsion test to assess anorectal function. All tests are susceptible to measurement artifacts. The standard technologies for anorectal assessment are anorectal manometry, balloon expulsion test and defecography. Endoluminal Functional Lumen Imaging Probe (EndoFLIP©) is a novel technology, originally used to measure the dimensions and function of a hollow organ. Anorectal manometry, balloon expulsion test, defecography, and the EndoFLIP probe will be used in the proposed studies. In addition, the proposed study intends to use a simulated feces named Fecobionics which is a device that integrates several technologies into one which will save time and reduce test variability. In the proposed studies investigators will assess defecatory function in subgroups of Hong Kong patients suffering from chronic constipation and faecal incontinence and determine biomarkers to increase the diagnostic value of anorectal testing. Investigators will study up to 130 patients with anorectal disorders and 101 healthy control subjects. Investigators anticipate to improve diagnostics of anorectal disorders considerably and to learn about physiological mechanisms that affect defecatory efficacy.

Start: August 2017

Effects of Exercise Training on Pelvic Floor Symptoms and Function in Adults With Constipation

Constipation is a common problem in the general population. Defecation disorders caused by abnormal contraction or insufficient relaxation of the pelvic floor muscles during defecation may be one of the most possible causes of constipation. Although constipation is not life-threatening, it may have a significant impact on the quality of life. Aerobic exercise has been shown to improve symptoms of constipation in adults with constipation. However, there is no research investigating the effects of a combined resistance and aerobic training on pelvic floor symptoms and pelvic floor muscle function in this population and only few studies have evaluated the pelvic floor muscle function using objective assessment tools among this population. The aim of the study is to investigate the effect of a combined resistance and aerobic exercise training program on constipation symptoms and pelvic floor muscle function in adults with constipation. The investigator will conduct a randomized controlled trial to evaluate the effectiveness of exercise training for adults with constipation. This study hypothesizes that (1) a combined resistance and aerobic exercise training can improve pelvic floor symptoms and function in adults with constipation, and (2) the improvement in combined resistance and aerobic exercise training group will be higher than that in control group.

Start: January 2021

Does a Preoperative Bowel Regimen Change Time to First Bowel Movement After Robotic Sacral Colpopexy

The hypothesis is that starting a bowel regimen with Polyethylene Glycol prior to robotic assisted sacrocolpopexy will decrease time to first bowel movement after surgery. The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. The control group will not be given any intervention preoperatively. All patients will take polyethylene glycol postoperatively.

Start: December 2019

Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety "Roll-over" Study (Rollover)

This 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.

Start: July 2020

Parkinson's Disease and Digestive Health

This study focuses on the relationship between the brain and the gut, and additionally will foster collaboration between Movement Disorder experts and Neurogastroenterologists to provide critical information and lead to innovative therapies in the future to treat GI dysfunction of Parkinson's Disease.

Start: October 2017

Point-of-care Anorectal Testing to Predict Outcomes With Biofeedback Therapy: Clinical Trial

To prospectively evaluate the clinical utility of baseline anorectal function testing using a point-of-care device in predicting response of chronically constipated patients to physical therapy biofeedback training.

Start: June 2020

Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)

This study will be conducted as a multi-center, randomized, double-blind, placebo-controlled study. Approximately 72 patients will be randomized 3:1 to treatment or placebo, with approximately 54 patients allocated to receive the active investigational product and approximately 18 patients allocated to receive placebo. - Study Update- Amendment 3 - In this amendment, an additional 80 patients (approximately) will be randomized 1:1 to treatment or placebo (double-blind) with approximately 40 subjects allocated to each group.

Start: December 2018

Assessment and Validation of Electronic Gas and Bloating Diary

The investigator's goal is to improve the patient's compliance and accurate capture of patient reported gas and bloating symptoms, by utilizing a phone application that interactively records each gas and bloating event in addition to bowel events and other bowel symptoms. Such an electronic stool diary may relieve the burden of using a paper daily stool diary. The investigator will compare and validate the electronic gas and bloating diary with the paper gas and bloating diary.

Start: September 2020