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Intestinal Diseases clinical trials

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NCT ID: NCT05374967 Active, not recruiting - Fatigue Clinical Trials

The Effect of a Multimodal Lifestyle Intervention on Chronic Fatigue in Patients With Inflammatory Bowel Disease

Multi-IBD
Start date: May 12, 2022
Phase: N/A
Study type: Interventional

Chronic fatigue is highly prevalent in patients with conditions characterized by chronic inflammation of the gastrointestinal tract, also known as Inflammatory Bowel Disease (IBD). Chronic fatigue has multiple causes, including alterations in immune system or gut microbiota, psychological factors, and sleeping problems. Unsurprisingly, fatigue has been associated with decreased quality of life, general well-being, and work productivity. Very few patients experience resolution in fatigue, emphasizing the need for new therapies. It has been shown that lifestyle interventions can improve most of fatigue-driving factors. Hence, the investigators hypothesize that a multimodal lifestyle intervention focusing on nutrition, sleep, stress, and exercise will improve chronic fatigue in patients with IBD. During this multicenter, controlled trial, the investigators will compare a multimodal lifestyle intervention to a standard therapy (i.e., an informational brochure on how to cope with chronic fatigue).

NCT ID: NCT05371067 Recruiting - Clinical trials for Gastro-Intestinal Disorder

Fructose Effect on Neuroinflammation and Feelings

MOODYFRUCTOSE
Start date: June 8, 2021
Phase: N/A
Study type: Interventional

Fructose is increasingly present in our food. The increase in its consumption is associated with the increase in the prevalence of several pathologies such as metabolic syndrome or hepatic steatosis. The effect of fructose consumption on brain health has been poorly studied. Studies in animal models show that diets enriched in fructose promote the development of emotional behavior disorders. Fructose malabsorption is also associated with changes in the microbiota that could also impact brain health. However, no human study to date has associated fructose malabsorption with changes in the gut microbiota and effects on brain health. The objective of this study is to study the emotional behavior of a population of healthy volunteers according to the presence or not of fructose malabsorption. Patients with fructose malabsorption are susceptible to gut dysbiosis without necessarily consuming high amounts of fructose.

NCT ID: NCT05368246 Completed - Clinical trials for Urinary Incontinence

Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD)

Start date: February 15, 2022
Phase: N/A
Study type: Interventional

This clinical investigation is a single-arm, prospective, multicentre, early feasibility study, which is used to evaluate the device design of UCon with respect to initial clinical safety and device performance in a small number of subjects. UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel disorders (BD). It electrically stimulates the dorsal genital nerve (DGN) through the skin to obtain modulated behaviour of the bladder/bowel musculature e.g., suppress undesired bladder/bowel activity to relieve the symptoms of the patient.

NCT ID: NCT05351138 Completed - Cerebral Palsy Clinical Trials

Comparison of Transcutaneous Electrical Nerve Stimulation and Manual Therapy in Children With Cerebral Palsy

Start date: January 30, 2023
Phase: N/A
Study type: Interventional

There are many studies in the literature on healthy children with lower urinary tract dysfunction (LUTD), but there are limited number of studies in children with cerebral palsy (CP) with LUTD. This study aim to contribute to the literature by examining the effectiveness of transcutaneous electrical nerve stimulation (TENS) and abdominal massage in the treatment of children with CP with LUTD and comparing the superiority of the two treatment methods to each other.

NCT ID: NCT05351034 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

The Role of High-resolution Anorectal Manometry in the Diagnosis of Functional Anorectal Disorders in Patients With Inactive Inflammatory Bowel Disease

Start date: June 2022
Phase: N/A
Study type: Interventional

The study aimed at diagnose and to detect the incidence of functional anorectal disorders in patients with inactive inflammatory bowel disease and to highlight the role of anorectal manometry in evaluating IBD patients with persistent defecatory dysfunction .

NCT ID: NCT05350644 Recruiting - Ulcerative Colitis Clinical Trials

Inflammatory Bowel Disease(IBD), Treatment Response

Start date: February 8, 2022
Phase:
Study type: Observational

Inflammatory bowel diseases (IBD) is treated with biologics targeting the pro-inflammatory molecule tumour necrosis factor-α (TNF), i.e. TNF inhibitors. Up to one third of the patients do, however, not respond to biologics and little is known of the biological mechanism as a prognostic factor (possibly enabling personalised medicine). The aim of this project is to identify biomarkers that support individualized forecasting of optimized treatment outcome on these costly drugs. This prospective cohort study will enroll IBD patients assigned for biologic treatment. At baseline (Pre-treatment), biopsies and blood is taken from each patient. Follow-up will be conducted at week 14-16 after treatment initiation (according to the current Danish standards). Evaluation of a successful treatment outcome response will - for each disease - be based on most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients with the cell expression. The overarching goal of this project is to improve the lives of patients suffering from IBD, by providing evidence to potential biomarkers that would be likely to improve the clinical outcome. The study is approved by the local Ethics Committee (S-20160124) and the local Data Agency (2008-58-035). The study findings will be disseminated in peer-reviewed journals, via patient associations, and presented at national and international conferences.

NCT ID: NCT05322486 Recruiting - Neoplasms Clinical Trials

Palliative Primary Tumor Resection in Minimally Symptomatic Patients With Colorectal Cancer and Synchronous Unresectable Metastases

Start date: October 29, 2020
Phase:
Study type: Observational

Currently, the question remains whether palliative primary tumor resection could improve overall survival of minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases. The aim of this study is to determine if there is an improvement in overall survival of palliative primary tumor resection followed by chemotherapy in minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases compared to those of upfront chemotherapy/radiotherapy alone.

NCT ID: NCT05321485 Recruiting - Ulcerative Colitis Clinical Trials

The Effect of MedicijnWijs on Adherence to Azathioprine Therapy in Adolescents With IBD

MEDICATION
Start date: March 16, 2022
Phase: N/A
Study type: Interventional

Medication non-adherence is an existing problem in patients with inflammatory bowel diseases (IBD). Adherence rates are especially low in children and adolescents. Good medication adherence is key in achieving lower disease activity and longer periods of remission. Previous research has shown education can increase medication adherence. MedicijnWijs is a mobile phone app containing a module concerning a 6-weeks guidance with azathioprine therapy. It provides information about IBD and azathioprine. In this multicenter before-and-after study, the aim is to assess the effect of MedicijnWijs on the adherence to azathioprine therapy in adolescents with IBD. This is done using two validated questionnaires that are translated to Dutch: the Medication Adherence Report Scale-5 (MARS-5), which tests the participants' adherence to azathioprine therapy, and the Inflammatory Bowel Disease Knowledge Inventory Device 2 (IBD-KID2), which tests the participants' knowledge about IBD. These questionnaires are filled in at the beginning of the study period and after 6 weeks of using MedicijnWijs. This way a change in both scores can be assessed. The investigators hypothesize that MedicijnWijs will help increase the adherence to azathioprine therapy in adolescents with IBD.

NCT ID: NCT05318365 Recruiting - Clinical trials for Bladder and Bowel Dysfunction

Bladder and Bowel Dysfunction in Children

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Background: Bladder and bowel dysfunction (BBD) is characterized by lower urinary tract symptoms accompanied by bowel complaints. BBD is a common condition in childhood. The present treatment strategy for BBD is a step-wise approach starting with management of bowel symptoms before initiation of standard urotherapy and further medical treatment of LUTS symptoms. This is, however, based on clinical experience and few retrospective, non-randomized studies and high-level evidence of the succession of the elements in treatment of BBD children is missing. Our microbiome, and its role in health and disease, has gained increased focus during the past years. Studies suggest the urine and gut microbiome to be critical for maintenance of a well-functioning bladder- and bowel system. The microbiome in children is only sparsely investigated and its role in BBD is to the investigator's knowledge still unexplored. Study 1: Aim: To investigate if combination therapy is more effective in treating urinary incontinence in BBD children. Materials and methods: A prospective randomized multicentre study on children with BBD (n=100) between 5-14 years and 9 months old. They are randomized to: 1) Medical treatment of bowel symptoms (n=50) or 2) Medical treatment of bowel symptoms combined with standard urotherapy. The effect of treatment will be evaluated after 3 months. Primary endpoint: Resolution of incontinence after treatment. Secondary endpoint: Improved quality of life after successful treatment of urinary incontinence. Study 2: Aim: To investigate the urofecal microbiome in children with BBD Materials and methods: 1. A cohort study to investigate, whether the urofecal microbiome can predict response to treatment and whether it changes during treatment period 2. A case control study to investigate whether the urofecal microbiome is different in children with BBD and recurrent UTI 's and children with BBD without recurrent UTI 's. The study population consists of children with BBD included in study 1. A urine-, stool sample and a perineum swab will be collected from all participants before and after treatment. Bacterial DNA will be extracted and the microbiome will be determined. Perspectives: BBD is a common condition in childhood. It is associated with a considerable psychological burden and a risk of more severe physical complications. The studies will provide basic knowledge about characteristics of the BBD patients and contribute new information about the optimal treatment of BBD children.

NCT ID: NCT05316584 Recruiting - Ulcerative Colitis Clinical Trials

A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy

ASSIST
Start date: September 6, 2022
Phase: N/A
Study type: Interventional

The investigators hypothesize that use of a remote monitoring digital health system that supports medication taking and monitoring of symptoms will improve adherence, clinical outcomes, and decrease healthcare utilization compared to standard care in participants with inflammatory bowel disease initiating oral or subcutaneous treatment. The investigators are conducting a 12-month, multicenter, randomized, controlled trial to assess the feasibility and effectiveness of a remote monitoring digital health system on adherence, clinical outcomes, and healthcare utilization. The investigators will address the following specific aims: 1. Compare adherence as measured by the medication possession ratio in participants using a remote monitoring digital health system compared to standard of care. 2. Compare clinical outcomes and healthcare utilization in participants using a remote monitoring digital health system compared to standard of care.