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Constipation clinical trials

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NCT ID: NCT04457791 Completed - Constipation Clinical Trials

Improving Constipation by Stimulating Fiber Intake Using Personalized Dietary Advice

PAC
Start date: August 31, 2020
Phase: N/A
Study type: Interventional

Rationale: constipation-related complaints are prevalent in 5-20% of the population. Dietary fibers play a crucial role in improving and maintaining gut health, increasing stool weight, stool frequency and improvement of stool consistency. Currently, very few adults meet the recommendation of 30 (females) or 40 (males) grams of fiber per day. Personalized dietary advice may be the solution to increase dietary fiber intake and reduce constipation-related complaints in large populations. Objective: To investigate the effectiveness of personalized dietary advice (PDA) in reducing constipation-related complaints, by increasing dietary fiber intake in people with constipation-related complaints. Study design: This study has a one-group pre-test post-test design with a run-in period. The duration of the study is 8 weeks, which includes a 4-week run-in phase and a 4-week intervention period. All subjects receive the PDA. Study population: adult subjects with constipation-related complaints, defined as predominant Bristol stool form between 1-4 and not satisfied with their bowel habits (scale ranging from 1-10, cut-off <6). Possibly stool frequency ≤4 stools per week will be included as a definition. Subjects need to have a relatively low dietary fiber intake defined as <26 grams (females) or <33 grams (males), which is ≥15% below the recommendation of fiber intake. Intervention: personalized advice based on their habitual food pattern (as assessed using a food frequency questionnaire) and preferences. Based on a special algorithm, the PDA provides high fiber alternatives for low-fiber products that subjects currently use, close to their current eating behavior, to help increase dietary fiber intake. This PDA will be provided using an online web-portal. Main study parameters/endpoints:primary outcomes are stool pattern, gastrointestinal complaints and constipation quality of life and severity. Secondary parameters include dietary fiber intake, physical activity, body weight, psychological questionnaires, and fecal microbiota composition and metabolite levels. Furthermore, the PDA will be evaluated.

NCT ID: NCT04451096 Completed - Parkinson Disease Clinical Trials

Probiotics-prebiotic Fiber Therapy in Parkinson's Disease Patients With Constipation

Start date: October 6, 2018
Phase: Phase 3
Study type: Interventional

A double blinded randomised placebo controlled trial to evaluate the efficacy of probiotics on constipation symptoms and whole gut transit time in patients with Parkinson's disease.PD patients with constipation were randomized to receive a multi-strain probiotic (Lactobacillus spp and Bifidobacterium spp at 30 X 109 CFU) with fructo-oligosaccaride (FOS) or placebo (fermented milk) twice daily for 8 weeks. Primary outcomes include changes in the presence of constipation symptoms using 9 items of Garrigues Questionnaire (GQ), which included an item on bowel opening frequency. Secondary and exploratory outcomes include whole gut transit time (WGTT), quality of life (PDQ39-SI), motor (MDS-UPDRS) and non-motor symptoms (NMSS).

NCT ID: NCT04437147 Completed - Clinical trials for Functional Constipation

Effect of Probiotics on Functional Constipation in Adults

PROBCON
Start date: March 11, 2020
Phase: N/A
Study type: Interventional

Introduction: Functional constipation is a symptom-based gastrointestinal disorder without an organic origin (eg, bowel obstruction). It has a prevalence of 14% in adults. Objective: The objective of trial is to evaluate the efficacy and safety of two different probiotic blends in adults subjects with functional constipation. Methods: A double-blind, randomized, placebo-controlled study will be conducted for up to two years to evaluate the efficacy of two different probiotic mixtures: (Mixture 1) Lactobacillus acidophilus, Bifidobacterium bifidum and Lactobacillus rhamnosus (3 billion CFU); (Mixture 2) Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus rhamnosus, Lactobacillus paracasei, Bifidobacterium longum, Bifidobacterium lactis, Lactobacillus defensis, Bifidobacterium animallis (8 billion CFU).

NCT ID: NCT04433390 Completed - Clinical trials for Postoperative Ileus (Post Cardiac Surgery Constipation)

Effect of Naloxegol on Postoperative Ileus in Patients Undergoing Cardiac Surgery

TRANSIT
Start date: October 14, 2020
Phase: Phase 3
Study type: Interventional

Postoperative ileus, defined as the transient postoperative functional inhibition of propulsive bowel activity, commonly occurs in patients after cardiac surgery and contributes to postoperative morbidity. Naloxegol is a peripheral opioid receptor antagonist. Recent studies showed that naloxegol is effective in the treatment of chronic opioid-induced constipation but there is no data on its use in the management of postoperative ileus after cardiac surgery. The main objective of this prospective, double-blind, randomized, placebo-controlled trial is to assess the effectiveness of the perioperative use of naloxegol in reducing the duration of the postoperative ileus in patients undergoing cardiac surgery.

NCT ID: NCT04415710 Completed - Clinical trials for Urinary Incontinence

Pelvic Floor and Sexual Dysfunction in Women With Sjogren's Syndrome

Start date: February 21, 2019
Phase:
Study type: Observational [Patient Registry]

Sjogren's syndrome (SS) is a chronic, systemic, autoimmune disease characterized by lymphocytic infiltration of all exocrine glands, especially tear and salivary glands, and is more common in women.

NCT ID: NCT04404933 Completed - Cancer Clinical Trials

Study of Opioid-Induced Constipation 2 Project

StOIC-2
Start date: August 21, 2017
Phase:
Study type: Observational

The aim of the project is to investigate OIC in a real world / diverse group of patients with cancer. The objectives of the project are to determine: a) efficacy of a treatment algorithm to manage OIC; b) efficacy of conventional laxatives to manage OIC; c) efficacy of PAMORAs / other interventions to manage OIC.

NCT ID: NCT04382456 Completed - Constipation Clinical Trials

Evaluation of Acacia Gum on Microbiome and Bowel Function in Participants With Chronic Constipation

Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Proof of concept study to investigate the impact of a food supplement consisting of Acacia gum on changes of gut microbiota and production of short chain fatty acids. Additionally, safety, tolerability and parameters of bowel function (stool frequency, stool consistency and gastrointestinal symptoms) will be assessed during the study.

NCT ID: NCT04380090 Completed - Constipation Clinical Trials

Post-Operative Constipation Following Total Knee Arthroplasty

Start date: February 21, 2020
Phase: Phase 2
Study type: Interventional

Postoperative constipation, defined as no fully satisfying bowel movement within the first three postoperative days, is a common occurrence with some researchers estimating that between 41 and 85% of postoperative patients experience symptoms. Causes include intraoperative medications, postoperative opioid analgesics, decreased mobility, and decreased oral intake. Constipation significantly impacts quality of life following surgery. Current standard of care for preventing postoperative constipation for patients having a single total knee arthroplasty at Cleveland Clinic is discharge on postoperative day one with either a prescription to be filled for docusate sodium (brand name Colace®) 100 mg to be taken two times a day by mouth for twenty eight days or the filled prescription, plus discharge instructions on ways to avoid and treat constipation. Research results show that docusate sodium is ineffective for preventing postoperative constipation in orthopedic surgery patients, and anecdotal reports confirm this finding. The proposed study uses a 2-group non-equivalent cohort design to evaluate the effect of one standard dose (17 grams) of an over-the-counter osmotic laxative (propylene glycol (PEG 3350), brand name Miralax) by mouth prior to discharge to the current standard of care. The primary outcome measure is whether patients report of a fully satisfying, normal for them, bowel movement within the first three postoperative days. Patient reported data will be collected by phone call four to seven days following surgery. Pertinent patient characteristics will be abstracted from the electronic medical record. The sample will consist of patients over twenty years old having a single total knee arthroplasty by Drs. Stearns, Molloy, or Murray who are admitted to unit 5D at Cleveland Clinic Lutheran Hospital postoperatively. Intent to treat analysis will be performed using logistic and linear regression models, adjusting for differences between groups on patient and surgical characteristics. Based on use of a two-sided Pearson chi-square test with 80% power and significance level of 0.05, 49 patients per group are required to detect a 25% decrease in constipation rate. To account for attrition we will over sample by 50% for a total of 74 per group or 148 total participants.

NCT ID: NCT04373772 Completed - Constipation Clinical Trials

Effect of Abdominal Massage on Bowel Evacuation After Cranial Surgery

Start date: July 1, 2015
Phase: N/A
Study type: Interventional

Many factors in patients undergoing cranial surgery (CS) may affect the bowel evacuation of patients, resulting in constipation, which could lead to the use of the valsalva maneuver. The aim of this study was to determine the effect of abdominal massage (AM) on bowel evacuation of patients treated in intensive care units (ICU) after CS.

NCT ID: NCT04350112 Completed - Cancer Clinical Trials

Study of Opioid-Induced Constipation 1 Project

StOIC-1
Start date: August 21, 2017
Phase:
Study type: Observational

The aim of the project is to investigate opioid-induced constipation (OIC) in a real world / diverse group of patients with cancer. The objectives of the project are to determine: a) prevalence of OIC; b) clinical features / impact of OIC; c) management of OIC.