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Constipation clinical trials

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NCT ID: NCT05040139 Completed - Clinical trials for Fecal Incontinence With Fecal Urgency

A Comparison of Quality of Life Between MAlone Procedure and Percutaneaous Endoscopic Caecostomy in Patients With Antegrade Colonic Enema

MAPEC
Start date: November 13, 2018
Phase:
Study type: Observational [Patient Registry]

Background: Antegrade colonic enema (ACE) is a second intent treatment of severe constipation and/or fecal incontinence following the failure of medical treatment. ACE is classically administered through a percutaneous access to the caecum performed surgically according to the Malone procedure (MP). Recently, a novel endoscopic approach named Percutaneous Endoscopic Caecostomy (PEC) has been proposed to perform the percutaneous access to the caecum. PEC has never been compared to the traditional MP in terms of postoperative quality of life and functional outcomes. Objective: The aim of the study is to compare postoperative quality of life between MP and PEC in patients treated with ACE for severe constipation and/or fecal incontinence. Hypothesis: MP and PEC achieve similar quality of life outcomes. Methods: All patients from two prospective databases who underwent MP or PEC for severe constipation and/or fecal incontinence between 2006 and 2016 will be included. They will be contacted to answer questionnaires about quality of life (GIQLI) and functional outcomes including constipation, fecal incontinence and body image assessment (KESS, Wexner and BIQ scores respectively). The main measured outcome will be GIQLI score. Results: The results of this comparative study will determine if the endoscopic and the surgical approaches are similar in terms of quality of life, or if one of them is better than the other. This study will clarify the optimal protocol to perform a caecal percutaneous access before ACE administration in patients suffering from severe constipation and/or fecal incontinence.

NCT ID: NCT05036369 Completed - Clinical trials for Constipation Chronic Idiopathic

Vibrant Capsule vs. Placebo for Patient Suffering From Constipation

Capsule
Start date: July 5, 2021
Phase: N/A
Study type: Interventional

The objectives are to assess the efficacy and safety of Vibrant capsule administered twice a week

NCT ID: NCT05035784 Completed - Clinical trials for Fecal Microbiota Transplantation

RCE With FMT in the Treatment of Childhood Constipation

Start date: November 10, 2020
Phase: N/A
Study type: Interventional

Constipation is the most common complaint in childhood gastrointestinal disease, affecting an estimated 20% of the global children.The treatment strategies consist of diet control, behavioral intervention and oral and sometimes rectal laxatives. Given higher success rate and fewer side effects, the laxative PEG3350 has been considered the first choice in childhood constipation.However, effectiveness of PEG 3350 laxative is not lasting, and the use of PEG increases the risk of fecal incontinence. Additional treatment interventions are still necessary.Enema can act directly on the rectum and distal colon to quickly relieve symptoms of fecal impaction which is considered one of main source of intractable constipation. Children with fecal impaction who received enema had fewer fecal incontinence and diarrhea than children who received PEG. There have been lots of evidence that enema is effective in fecal impaction in children with functional constipation.But there are still cases of recurrences noted after enema. Fecal bacteria transplantation (FMT) is a new treatment method emerging in recent years, which is widely used in the treatment of functional gastrointestinal diseases. FMT has been proved to play a very prominent role in correcting intestinal flora disorders. By transplanting exogenous flora into the intestinal tract of patients, FMT can inhibit bacterial reproduction, regulate intestinal environment and cascade the body immunity, so as to achieve the therapeutic effect of disease. Retrograde colonic enema with FMT, an new method, provides the possibility for the treatment of childhood constipation. However, there is still a lack of evidence-based support for the treatment of childhood constipation by retrograde colonic enema with FMT. Therefore, we designed a randomized, controlled, double-blind clinical trial to confirm the efficacy and safety of retrograde colonic enema with FMT in the treatment of childhood constipation.

NCT ID: NCT05032534 Completed - Fecal Incontinence Clinical Trials

Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence

Start date: September 20, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to investigate if a new irrigation system for transanal irrigation (TAI) is effective and more tolerable than the currently used system at the Pediatric Ward at Aarhus University Hospital.

NCT ID: NCT05025553 Completed - Constipation Clinical Trials

Oral Administration of Polyethylene Glycol (PEG) for 6 Months in Chronically Constipated Autistic Children

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Many autistic children suffer from chronic constipation. Gut mobilization was obtained administering polyethylene glycol (PEG) at the dose of 6.9 g/d once a day for 6 months in an open trial involving 21 chronically constipated autistic children 2-8 years old, followed prospectively for 6 months. Children diagnosed with Autism Spectrum Disorder by DSM-5 and confirmed by ADOS-2 criteria, were evaluated before (T0), 1 month (T1), and 6 months (T2) after intestinal mobilization, recording Bristol stool scale scores, urinary p-cresol concentrations, and behavioral scores for social interaction deficits, stereotypic behaviors, anxiety, and hyperactivity.

NCT ID: NCT04997187 Completed - Clinical trials for Constipation - Functional

Effect of Bacillus Coagulans in Adults With With Functional Constipation

Start date: July 20, 2021
Phase: N/A
Study type: Interventional

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans on various symptoms and fecal microbial diversity in adults with with functional constipation for 12 weeks.

NCT ID: NCT04997057 Completed - Clinical trials for Irritable Bowel Syndrome With Constipation

A Multistrain Probiotic in Patients With Irritable Bowel Syndrome With Predominant Constipation

EPORE
Start date: January 4, 2022
Phase: N/A
Study type: Interventional

Probiotics efficacy is mainly assessed by subjective endpoints such as the FDA responder rate or global relief, which partly explain contradictory results obtained in clinical trials with probiotic bacteria. Objective biomarkers of IBS will allow to measure the efficacy of probiotics. In the case of IBS-C, serum resolvin-D1 appears to be an interesting candidate due to its non-invasive and discriminating character compared to a healthy population. It is, inversely correlated with the severity of symptoms. Resolvin-D1 modulates the duration and intensity of inflammation by regulating the transcription of cytokines, chemokines and their receptors as well as other proteins involved in inflammation. Resolvin D1 could serve as a predictor of probiotic response based on its baseline value.

NCT ID: NCT04996186 Completed - Multiple Sclerosis Clinical Trials

Symptoms and Treatment Assessment of Ano-Rectal Disorders in Multiple Sclerosis Patients : STAR-Q

STAR-Q
Start date: June 1, 2019
Phase:
Study type: Observational

Multiple sclerosis (MS) is known to cause urinary disorders, sexual and bowel dysfunction. Urinary symptoms due to MS are well known and profit of multiple questionnaire or tool developed in MS patients. Prevalence of bowel disorders in MS is difficult to assess. Some studies up to 70% bowel disorders in MS patients. Constipation and fecal incontinence are the two main symptoms in neurogenic bowel dysfunction and frequently coexist in this population, generally in association with urinary disorders. Because of the high prevalence of bowel disorders their and the major impact on the quality of life of patients with Multiple sclerosis (PwMS) , and the cross-talk bladder-rectum (persistence of anorectal dysfunction leading to poor neurogenic bladder control) assessment of bowel disorders in MS is necessary. But this evaluation is difficult as no specific score exist. The neurogenic Bowel Dysfunction score (NBD) is often used. The NBD was developed and validated for spinal cord injury (SCI) population but not for PwMS MS. Yet NBD is often used in research for all neurologic patients despite its lack of sensibility in various neurogenic population other than spinal cord injury patient. As recommended in a Cochrane revue in 2014, there is a need of a specific evaluation for bowel symptoms in neurogenic population, especially for PwMS. The aim of the study was to create and validate a new multidimensional questionnaire to assess bowel dysfunction and impact on quality of life in patients with MS. The investigators conducted a prospective multicenter study (8 centers) between June 2019 to April 2021. This study was developed in 3 steps. First step was literature review and qualitative interview. Then the second step was the feasibility study to evaluate comprehension, acceptability of the different items. The last part of the study was the validation study of the questionnaire. This part of the study was performed between June2020 and April 2021. Validation study allowed to determine the psychometric properties of the new tool. Patients aged over 18 years with multiple sclerosis diagnosed on the 2017 revised McDonald's criteria were included. Patients not able to read or understand the objectives and procedures for conducting the protocol and patient who had a recent relapse of MS were excluded.

NCT ID: NCT04977063 Completed - Gastroparesis Clinical Trials

Atmo SmartPill Comparison in Gastroparetic and Slow Transit Constipation Patients

Start date: August 15, 2021
Phase: N/A
Study type: Interventional

This study will compare gastrointestinal transit time measured by the SmartPill and the Atmo gas capsule in patients with gastrointestinal motility disorders. Both of these devices allow gastrointestinal transit time to be measured, however the SmartPill senses pH changes whereas the Atmo Capsule measures gas profiles. A total of 60 participants (30 diagnosed with gastroparesis, 30 with slow transit constipation) will attend Macarthur Clinical School at Western Sydney University after an overnight fast. Participants will consume a standardised meal before ingesting the SmartPill and Atmo Capsule. Each participant will carry a data receiver until passage of the capsules. Anatomical landmarks will be defined by pH changes (SmartPill) or oxygen profiles (Atmo Capsule). Statistical analysis will be performed via linear regression and degrees of agreement for measurements between the two devices. Primary end-points will be the agreement between gastric emptying, small intestinal and colonic transit times generated by the devices.

NCT ID: NCT04968652 Completed - Clinical trials for Functional Constipation

IBS-C Questionnaire Study

Start date: November 1, 2021
Phase:
Study type: Observational

The study is a multi-centre, observational study which enrolls 150 IBS-C patients and 150 non-IBS-C patients in China.