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Intestinal Diseases clinical trials

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NCT ID: NCT06338189 Recruiting - Clinical trials for Irritable Bowel Syndrome

The 5Ad Diet for Functional Bowel Disorders

Start date: May 8, 2022
Phase: N/A
Study type: Interventional

The goal of this randomised controlled trial (RCT) is to compare the efficacy of the newly developed 5Ad diet against the widely researched low fermentable oligo-, di-, monosaccharide and polyols (FODMAP) diet in reducing gastrointestinal symptoms associated with functional bowel disorders/food intolerances. The primary aims of this RCT are to determine: - Whether the 5Ad diet is at least as effective as the low FODMAP diet in reducing gastrointestinal symptoms associated with FBDs/food intolerances. - Whether either the 5Ad diet or the low FODMAP diet are effective in reducing mental and physical fatigue. To achieve the above aims, an RCT will be conducted with the 5Ad diet in one arm vs the active phase of the low FODMAP diet in the other arm, in a cross-over design with a 7 days washout phase in between. Both dietary protocols will be followed by each participant for 7 days. Researchers will compare the results from the 2 dietary protocols in order to ascertain the superiority of one over the other in regards to 6 gastrointestinal symptoms (abdominal pain, bloating, flatulence, bowel urgency, straining and incomplete defecation), stool form and frequency of defecation.

NCT ID: NCT06334198 Recruiting - Constipation Clinical Trials

The Effect of Naldemedine on Opioid-induced Bowel Dysfunction

Start date: March 12, 2024
Phase: Phase 2
Study type: Interventional

Opioid-induced bowel dysfunction is a frequent condition during opioid therapy for chronic pain. Indeed, up to 90% of people on opioid treated patients experience constipation. Standard laxative treatment is often ineffective in opioid-induced constipation, but peripheral acting mu-receptor antagonists (PAMORAs) have the potential to block the effects of opioids in the gastrointestinal tract while preserving the central analgesic effect. In this study, we will investigated the effects of Naldemedine in preventing the development of opioid-induced bowel dysfunction and constipation during treatment with tramadol

NCT ID: NCT06321887 Recruiting - Clinical trials for Inflammatory Bowel Disease

EffiCacy and sAfEty of Low doSe orAl iRon for Anaemia in IBD

CAESAR
Start date: October 20, 2023
Phase: Phase 3
Study type: Interventional

Iron deficiency anaemia (IDA) is common in inflammatory bowel disease (IBD). However, although iron is commonly prescribed, the amount of elemental iron needed to achieve clinical efficacy, and the optimal method of supplementation, are under debate. This pilot study aims to investigate the efficacy and safety of low dose and standard dose oral iron preparations for the treatment of IDA in patients with IBD.

NCT ID: NCT06300541 Recruiting - Sarcopenia Clinical Trials

Prevalence and Impact of Sarcopenia in Patients With Inflammatory Bowel Disease

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

Sarcopenia is a condition characterized by significant muscle loss resulting in impaired muscle function. This condition is likely associated with a biological deviation leading to reduced reserves to withstand stressors, resulting in a poorer prognosis. The incidence of sarcopenia among patients with inflammatory bowel diseases (Ulcerative Colitis and Crohn's disease) is currently approximately 40-60%. This is likely a consequence of the preference for drug treatment over surgery, while many patients have continuous inflammation in their intestines leading to muscle loss and subsequently increased morbidity and mortality. The purpose of the study is to identify the prevalence of sarcopenia among patients experiencing a severe flare-up of their bowel disease and to evaluate whether the removal of the colon results in improved nutritional status. Furthermore, the investigators aim to investigate whether there is a specific microbiota composition related to an unfavorable course. The participants are longitudinally monitored with measurements taken at the flare-up/before surgery and one year afterward, including body composition, function, dietary recording, quality of life, blood tests, fecal samples, and intestinal biopsies that will be analyzed. The investigators plan to correlate body composition with a biological profile and then evaluate if there is an association. Additionally, the investigators aim to analyze if these markers are linked to different outcomes after colectomy. This study will contribute to an enhanced understanding of patients with advanced IBD and possibly change the perspective on how the clinicians should prioritize these patients for surgery. The investigators believe this study will lead to an improvement in healthcare quality and an enhanced understanding of how these disease processes function.

NCT ID: NCT06299423 Recruiting - Surgery Clinical Trials

Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients

PeRseo
Start date: November 22, 2023
Phase: N/A
Study type: Interventional

Anxiety and depression are extremely common among Inflammatory Bowel Disease (IBD) patients undergoing surgery and may increase the risk of postoperative adverse outcomes. This study aims to objectively evaluate preoperative psychological distress by remotely measuring the patient's physiological parameters and Heart Rate Variability (HRV) with the Howdy Senior ® device (Comftech Srl). Additionally, the study will also investigate the feasibility and effectiveness of the Howdy Senior® device in improving the postoperative patient's monitoring.

NCT ID: NCT06288464 Recruiting - Bowel Dysfunction Clinical Trials

Enteral Feeding of Fibre to Improve Microbiota

Start date: January 9, 2023
Phase: N/A
Study type: Interventional

Following surgical removal of diseased bowel, patients often require a temporary redirection of bowel contents to a stoma, to allow healing prior to re-joining of the remaining bowel at a later date. Some patients may experience complications, either during or after reversal surgery, and this may be due to changes in the 'friendly' bacteria that live in our bowels. Previous research shows that the distal section of bowel that is non-functioning undergoes tissue-wasting and the 'friendly' bacteria that help our digestion die. Data shows that patients that have a reduction in their microflora are more likely to experience side effects. This study investigates a method of replenishing the microflora prior to surgery.

NCT ID: NCT06281392 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Artificial Intelligence and Dysplasia Detection in Inflammatory Bowel Disease (EIIDISIA Study)

Start date: November 15, 2023
Phase: N/A
Study type: Interventional

Randomized clinical study analyzing the efficacy of colonoscopy assisted by the Computer Aided Detection (CADe) system compared to virtual chromoendoscopy with Narrow Band Imaging (NBI) in the detection of colon dysplasia in patients with long-standing inflammatory bowel disease (IBD).

NCT ID: NCT06271213 Recruiting - Healthy Clinical Trials

The Gut-Lung Axis and Respiratory Illness in Children

Start date: February 4, 2024
Phase:
Study type: Observational

The goal of this single-centre observational study conducted at the Royal Hospital for Children in Glasgow, Scotland, is to employ a multi-omics approach to investigate the "gut-lung axis" in health and disease. Part A is a cross-sectional study design investigating the postulated bidirectional link between the gut and lung microbiomes in children suffering from respiratory or gastrointestinal conditions. Children with no GI or respiratory issues attending for orthopaedic care will be used as a benchmark for a healthy gut-lung axis. The main questions we aim to answer are: - What does a healthy gut-lung axis look like? - Do children with respiratory issues show an altered gut microbiome? - Do children with GI issues show an altered lung microbiome? Part B is a longitudinal study design, that aims to assess the effects of biologics on the gut-lung axis by comparing the gut and lung microbiomes in children with asthma at two time-points who are indicated to start biologics therapy (Asthma treatment) or will not receive biologics therapy (asthma control). Participants will provide: - airway samples (to investigate the lung microbiome) - blood samples (to assess inflammatory and metabolic factors which may mediate communication between the two sites) whilst under general anaesthetic for a treatment related to their standard of care - stool samples (to assess gut microbiome) - dietary information (food diary and/or food frequency questionnaire) to assess relationships between diet and the gut-lung axis.

NCT ID: NCT06266663 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Social Determinants of Health, Medication Use, and Quality of Life in Inflammatory Bowel Disease

Start date: April 2024
Phase:
Study type: Observational

Optimizing health related-quality of life (HRQoL) for patients with inflammatory bowel disease (IBD), who often experience a relapsing disease course, is an essential component of care. Improving IBD disease control is linked to increased health-related quality of life. Even as many effective pharmacotherapies to promote disease control are available, evidence suggests that Hispanic and Non-Hispanic Black IBD patients may not receive full benefit from these therapies compared to their Non-Hispanic White counterparts. Underlying mechanisms that contribute to observed disparities in the use of IBD medical therapies are likely multifactorial. Adequate access to treatment has been implicated. Hispanic and Non-Hispanic Black IBD patients are more likely to be Medicaid-insured, and Medicaid insurance has been associated with increased emergency room visits, a proxy for sub-optimal IBD control. Medication adherence has also been proposed as a potential mediating factor. IBD therapies can be time-consuming and costly, which can pose a challenge in achieving medication adherence. While previous studies suggest Black IBD patients have lower medication adherence than Non-Hispanic White patients, it is unclear the extent to which social factors contribute to this observation. The purpose of this study is to evaluate the association between social determinants of health, medication adherence, and HRQoL among Hispanic and Non-Hispanic Black IBD patients. Understanding potentially modifiable psychosocial factors that contribute to medication adherence and HRQoL will provide targets for later intervention towards the goal of health equity.

NCT ID: NCT06266104 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Image Enhanced Endoscopy IBD

Start date: April 3, 2024
Phase: N/A
Study type: Interventional

Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future.