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Constipation clinical trials

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NCT ID: NCT06413368 Not yet recruiting - Cystic Fibrosis Clinical Trials

Maralixibat in Patients With Cystic Fibrosis and Constipation, A Within-Subjects Pilot Study

Start date: July 1, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Chronic constipation is a feature of children with cystic fibrosis (CF). This is postulated to be a result of inhibition of secretory activity of the gastrointestinal luminal cells due to ineffective chloride channel function. Typical laxatives that work as osmotic agents fail to produce adequate relief in this population. Maralixibat is a non-systemic bile acid transport inhibitor (IBATi) that acts by interrupting bile acid reabsorption in the ileum thus interrupting the normal enterohepatic circulation. This interruption results in a larger volume of bile acids reaching the colon and being excreted in stool. Bile acids are known to decrease bowel transit time, increase mucosal permeability and secretions, as well as alter gut microbiota resulting in diarrhea. The overarching hypothesis of the study is that Maralixibat will improve stool consistency in children (Age <18 years) with cystic fibrosis and constipation (Bristol Stool Scale <4). Specifically, we aim to test the hypothesis that IBATi improves the consistency of stool to Bristol scale >4 in children with CF and constipation. We will recruit a total of 20 patients with CF and constipation (defined as Bristol Stool Scale <4 for 1 week prior to enrollment while on a stable laxative regimen for at least 4 weeks.) Design is a 'Within-Subjects' study by which each enrolled patient will take Maralixibat for 2 weeks total in addition to their stable laxative regimen during the study. Stool consistency & ease of defecation will be recorded before and during the study period by families of enrolled patients via materials provided by the investigators. Stool consistency and ease of defecation will be compared before and after initiation of Maralixibat. The primary endpoint: Improvement in stool consistency to Bristol scale >4 in children with CF and constipation. The secondary endpoint: Improvement in ease of defecation in children with CF and constipation. This will be measured via survey using a standardized scale (Bristol Stool Scale) and questionnaires developed by the research team. Analysis will involve comparison of pre-intervention to post-intervention stool consistency & survey

NCT ID: NCT06408883 Not yet recruiting - Clinical trials for Chronic Functional Constipation

Effect of Vibration Capsule on Different Subtypes of Functional Constipation

Start date: June 1, 2024
Phase:
Study type: Observational [Patient Registry]

This study is a multi-center prospective cohort study, which plans to include 600 patients with chronic functional constipation to treat with Vibrabot capsules and patients will be grouped according to subtypes. During the study, the patients' basic information, baseline constipation status and treatment information, capsule intake during treatment, and concomitant medication will be collected. During the treatment phase, patients follow the doctor's advice to receive Vibrabot capsule treatment and maintain stable dietary intake and exercise according to the constipation diagnosis and treatment guidelines. During the study, patients need to fill in the relevant information during the treatment in the electronic questionnaire in a timely and truthful manner. The treatment effect of the patients is evaluated by assessing the number of occurrences of spontaneous bowel movements (SBM) and complete spontaneous bowel movements (CSBM).

NCT ID: NCT06404853 Completed - Clinical trials for Constipation - Functional

Effect and Safety of the Dietary Supplement Mannite in Pediatric Patients With Chronic Functional Constipation

MANNAPED
Start date: March 16, 2021
Phase: N/A
Study type: Interventional

Functional constipation is a widely prevalent pediatric issue, with a prevalence in some studies as high as 32.2%. Treatment consists of a combination of behavioral and pharmacological interventions (mainly, administration of polyethylene glycol laxatives or the use of enemas). Glucomannan (GNN) is a polysaccharide of 1,4-D-glucose and D-mannose found in the soluble fiber of some plants. While studies available in the literature to date agree that mannite is a dietary supplement with safe use, the usefulness of this compound remains controversial.

NCT ID: NCT06401460 Completed - Clinical trials for Coronary Heart Disease

Yannianjiuzhuan Method and Reverse Breathing Training to Improve Constipation in Elderly Patients With Coronary Heart Disease

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Primary Purpose: The primary purpose of this study is to evaluate the effectiveness of the Yannianjiuzhuan method combined with reverse abdominal breathing in improving symptoms of constipation, anxiety, sleep quality, and overall quality of life in elderly patients with coronary heart disease and constipation. Study Phase: As this research involves a non-pharmacological intervention, it is categorized as Not Applicable (N/A). Intervention Model: Parallel Assignment. Patients are divided into two groups; one receives standard care, while the other receives standard care supplemented by the Yannianjiuzhuan method combined with reverse abdominal breathing. Number of Arms: Two arms are involved in the study. One arm serves as the control group receiving standard care, and the other as the experimental group receiving standard care plus the Yannianjiuzhuan method combined with reverse abdominal breathing. Masking: This study employed a double-blind (assessors and statisticians), randomized, parallel-controlled trial design to enhance the credibility of the results and to minimize bias. Allocation: Using simple random sampling, small folded papers marked with the numbers "1" and "2" were placed in an opaque box. Each patient drew a paper in sequence of enrollment; those drawing a "1" were assigned to the control group, and those drawing a "2" to the experimental group, with each group comprising 35 participants. Enrollment: A total of 70 patients were initially recruited, with 67 completing the study. The control group had one participant drop out due to early hospital discharge related to the pandemic, affecting data collection completeness. In the experimental group, one participant was excluded due to undergoing colonoscopy and taking related laxative medications during the treatment, and another due to early hospital discharge caused by the pandemic. Thus, data from three participants were excluded from the final analysis due to insufficient treatment duration (less than two-thirds of the planned intervention), resulting in 34 participants in the control group and 33 in the experimental group being analyzed, equating to a dropout rate of approximately 4.3%, which is within acceptable statistical limits. Study Classification: This study focuses on efficacy assessment. It particularly evaluates the effectiveness of the Yannianjiuzhuan method combined with reverse abdominal breathing in alleviating symptoms of constipation, anxiety, improving sleep quality, and enhancing the quality of life among elderly patients with coronary heart disease and constipation.

NCT ID: NCT06399133 Completed - Constipation Clinical Trials

Care Package for Postoperative Constipation

Car_Package
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Background: Postoperative constipation is a common complication. The effectiveness of a care package constituting warm water intake, abdominal massage, and a high-fiber diet has not been investigated in patients undergoing orthopedic surgery. Aim: the investigators determined the effects of a care package, including warm water intake, abdominal massage, and high-fiber diet, on constipation prevention, aiming to improve patient quality of life during the postoperative period and support nurses in clinical practice. Study design: This was a single-center, randomized controlled trial of patients hospitalized in the Orthopedics and Traumatology Clinic of a state hospital between September 15, 2022, and April 30, 2023. Overall, 102 patients were randomly assigned to study and control groups. Routine clinical practice was maintained for patients in the control group, whereas a care package constituting postoperative warm water intake, abdominal massage, and a high-fiber diet was provided to those in the study group. Data was collected using the 'Constipation Risk Assessment Scale' and 'Visual Analog Scale'. Constipation severity was evaluated by administering the scales one day before surgery (T0) and one (T1), two (T2), three (T3), and four (T4) days postoperatively. Data were analyzed using SPSS software (version 20.0; IBM, Canada). Statistical significance was set at p < 0.05.

NCT ID: NCT06390761 Recruiting - Parkinson Disease Clinical Trials

Efficacy of Acupuncture for the Treatment of Parkinson's Disease Related Constipation

AFPDC
Start date: April 30, 2024
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the efficacy of acupuncture in treating Parkinson's disease related constipation (PDC). In the randomized controlled clinical trial study, patients meeting the criteria for inclusion will be randomly enrolled and divided into two groups in a 1:1 ratio: the acupuncture group and the sham acupuncture group. The intervention is going to be executed using the acupoints EX-HN1(Sishencong),LI4 (Hegu),ST25 (Tianshu),ST37(Shangjuxu),ST36(Zusanli),ST44 (Neiting), ST44 (Taichong), SP6 (Sanyinjiao) and CV4 (Shuangyuan).The acupuncture needles will be inserted to a depth of 0.8 to 1 cm in the acupuncture group. The sham acupuncture group's needles will be inserted to a depth of 0.2 to 0.3 cm with nonacupuncture points located 0.5 cm in lateral to the real acupoint or to the right for midline points. During the study, researchers will observe changes in complete spontaneous bowel movements (CSBMs), Constipation Symptom and Efficacy Assessment Scale (CSEAS) (including the six dimensions of difficulty, Bristol, time, incompleteness, frequency,and bloating), the Patient-Assessment of Constipation Quality of Life questionnaire (PAC-QOL), and the Unified Parkinson's Disease Rating Scale (UPDRS) at baseline (week 0), post-treatment (week 4), and follow-up (week 12).Colonic transit time measurement and conventional anorectal manometry were evaluated at the above time points.

NCT ID: NCT06388863 Not yet recruiting - Parkinson Disease Clinical Trials

Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Constipation in Parkinson's Disease

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Participants will be allocated to FMT group or placebo group at a 1:1 ratio. For interventional group, patients will be given six FMT capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell but contain milk powder. At each follow-up visits, participants complete specific scales to assess improvement in constipation, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa.

NCT ID: NCT06385561 Completed - Constipation Clinical Trials

The Influence of Tramadol on Opioid-induced Bowel Dysfunction

Start date: August 11, 2022
Phase: Phase 2
Study type: Interventional

Tramadol is a weak opioid and widely used to treat moderate to severe pain. Stronger opioids are known to inhibit gastrointestinal motility and secretion, however the effects of tramadol on gastrointestinal function remains less understood. The aim of this study was to determine to what degree tramadol causes opioid-induced bowel dysfunction by using an objective design to explore gastrointestinal transit, motility pattern, secretion, and colonic volume, in a group of healthy male volunteers.

NCT ID: NCT06381193 Completed - Clinical trials for Functional Constipation

Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics

Start date: March 3, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are: - To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks. - To evaluate the stool consistency after 8 weeks (Bristol scale). - To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks. Participants are randomized into the following groups: - Group A: 20 assigned to probiotic + placebo - Group B: 20 assigned to prebiotic + placebo - Group C: 20 assigned to probiotic + prebiotic - Group D: 20 assigned to the placebo + placebo Participants took 4 units of product per day (2 of each assigned product) for 2 months.

NCT ID: NCT06364111 Recruiting - Clinical trials for Chronic Functional Constipation

Comparative Study on the Efficacy of Vibrabot Capsule and Polyethylene Glycol for Chronic Functional Constipation

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

This is a single-center trial that enrolls 20 18 to 85-year-old patients with moderate to severe FC to study the efficacy of Vibrabot capsule (dosage: 5 capsules/week) and polyethylene glycol, as well as the mechanism of action of the Vibrabot capsule.