Exploration of the Activity of DNA Located Outside of Cellular Nucleus to Amplify Inflammation in...
Inflammatory Bowel DiseasesCrohn Disease1 moreFrequency of Inflammatory Bowel Diseases in children (IBD)-Crohn's disease (CD), Ulcerative colitis (UC) is constantly increasing. Pediatric-onset IBD represent a different nosological entity (from adult IBD) because of their major inflammatory activity, their significant anatomical extent and their stenotic and/or fistulizing character sometimes from diagnosis. Intestinal lesions are due to dysregulation of the intestinal immune system but the cause is unknown. The investigators hypothesize that extranuclear DNA participates in the amplification of the inflammatory response at the intestinal and blood levels during pediatric IBD through the cGAS-STING pathway. The investigators will analyse blood and fecal samples, and colonic biopsies issued from ill children and control participants on age of 6 to 17 years. The investigators think that this study will provide a better understanding of the mechanisms involved in pediatric IBD, assess the place of the cGAS-STING pathway, identify potential biomarkers of pediatric IBD and new potential therapeutic targets based in particular on the inhibition of the cGAS-STING pathway.
The Effect of Mycobiome Supplementation on Gastrointestinal Symptoms in IBD Patients
Ulcerative ColitisCrohn Disease1 moreStudies demonstrated that fungi have a complex, multifaceted role in the gastrointestinal tract and are active participants in directly influencing health and disease through fungal-bacterial, fungal-fungal and fungal-host interactions. Fungi have been linked with a number of gastrointestinal diseases including IBD, However, the exact role of fungal colonization in the pathophysiology of "IBD" (inflammatory bowel diseases) is not precisely defined. Aim to evaluate the impact of "Mycodigest" supplementation to IBD patients on: Clinical response and remission rates , Quality of life, Inflammatory markers, Fecal microbiome
The Effect of MedicijnWijs on Adherence to Azathioprine Therapy in Adolescents With IBD
Inflammatory Bowel DiseasesCrohn Disease1 moreMedication 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.
Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely...
Inflammatory Bowel DiseaseThe primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease. Results of this study may be pooled with the results of a separate study being conducted in participants with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis (Protocol GLPG0634-CL-227; NCT03926195) with the same objective. The total planned number of participants in both studies combined will be up to approximately 250 participants.
The Gut-Brain Study
Autism Spectrum Disorder (ASD)Gastro-Intestinal DisorderThe purpose of this study is to find out if transplant of fecal matter (stool), also known as fecal microbiota transplantation (FMT), from a healthy person into the intestines of children and young adults with Autism Spectrum Disorder (ASD). For this study children between the ages of 5-17years will be recruited over 2 years. Children will be recruited who receive an ASD diagnosis using the gold-standard Autism Diagnosis Observation Schedule -2 (ADOS-2) using module 1, 2 or 3 (none, limited or no moderate expressive language). Children diagnosed with these modules of the ADOS-2 may be at greater risk for GI disorders and rigid-compulsive behaviors. Additional assessment of rigid-compulsive behaviors and social communication will be done using the Repetitive Behavioral Scales-Revised (RBS-R) and Social Responsiveness Scale-2 (SRS-2), respectively. KBIT (the Kaufman Brief Intelligence Test) is used at baseline to obtain patient IQ. Total evaluation time is approximately 90 minutes. Following baseline symptom evaluation, a medical exam will be performed to determine whether each child is expressing specific GI symptoms. In addition, parents will fill out the Questionnaire for Pediatric Gastrointestinal Symptoms- Rome III (QPGS-III). Once an ASD diagnosis is confirmed, FMT treatment will be initiated, which typically occurs within 4-6 weeks of the initial diagnosis. Half 50% of the children (n=5) will receive the equivalent of 50 g of stools from a healthy donor into the jejunum through upper endoscopy and the other 50% off children (n=5) will receive Saline solution as Placebo control through upper endoscopy. Subjects will have a total of 5 visits within 24 weeks including phone call follow up on Day 7 after FMT.
Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With...
Ulcerative ColitisInflammatory Bowel DiseasesA double-blind, randomized, placebo-controlled clinical trial examining the efficacy and safety of Fecal Microbiota Transplantation (FMT) and high fiber supplementation in patients with active mild to moderate Ulcerative Colitis (UC). All enrolled subjects will provide serological, stool and mucosal specimen at each clinic visit to help further define the alterations in microbial profiles and immune cell function in response to psyllium fiber after FMT treatment.
The Effect of a Multimodal Lifestyle Intervention on Chronic Fatigue in Patients With Inflammatory...
Inflammatory Bowel DiseasesFatigueChronic 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).
The IBD-FITT Study - Moderate-intensity Exercise for IBD Patients With Moderate Disease Activity...
Inflammatory Bowel DiseasesThe investigators aim to investigate whether exercise therapy during 12 weeks including a lesson on general healthy lifestyle in adult patients with a moderately active disease is more effective, compared to control patients only receiving a lesson on general healthy lifestyle recommendations. The three main categories of outcomes are 1) health-related quality of life, 2) general health status of the patients 3) explorative outcomes. The primary outcome is health-related quality of life, the secondary outcome is general health status measured by waist circumference, disease activity scores, blood pressure, and blood lipids, and the third outcome are explorative outcomes (none-disease specific quality of life scores, biomarkers of C-reactive protein, fecal calprotectin and immunology markers including interleukins).
Open-Label Efficacy and Safety Study of Pozelimab in Patients With CD55-Deficient Protein-Losing...
CD55-deficient Protein-losing EnteropathyCHAPLEThe primary objective of the study is to determine the effect of pozelimab on active CD55-deficient protein-losing enteropathy (PLE; CHAPLE). The secondary objectives of the study are: To evaluate the safety and tolerability of pozelimab in patients with CD55-deficient PLE disease To evaluate the effect of pozelimab on CD55-deficient PLE (both patients with active disease at baseline and those with inactive disease on eculizumab, switching to pozelimab) To determine the effects of pozelimab on albumin and other serum proteins (total protein, immunoglobulins) To determine the effects of pozelimab on ascites To determine the effects of pozelimab on stool consistency To determine the effect of pozelimab on health-related quality of life To determine the effect of pozelimab on lab abnormalities observed in CD55-deficient PLE such as hypertriglyceridemia, thrombocytosis, and hypovitaminosis B12 To describe the effects of pozelimab on the sparing of concomitant medications and reduction in hospitalization days To determine the effects of pozelimab on growth To characterize the concentration of pozelimab in patients with CD55-deficient PLE To assess the incidence of treatment-emergent ADA for pozelimab in patients with CD55-deficient PLE disease
MTT for Children With ASD Who Have Gastrointestinal Disorders
Autism Spectrum DisorderGastro-Intestinal Disorder2 moreThe investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating children with Autism Spectrum Disorder (ASD) and gastrointestinal problems (primarily constipation and/or diarrhea). MTT involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by a bowel cleanse, followed by 12 weeks of Fecal Microbiota (FM).