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NCT ID: NCT06227598 Not yet recruiting - IBD Clinical Trials

From Nature to Bedside- Algae Based Bio Compound for Prevention and Treatment of Inflammation, Pain and IBD

Algae4IBD
Start date: May 1, 2024
Phase:
Study type: Observational

This study is part of the project funded by the Horizon2020 program for establishing the consortium Algae4IBD (https://algae4ibd.eu/), where Dept. of Molecular Medicine and Medical Biotechnologies (DMMBM) University of Naples Federico II participates as a partner. It aims to promote the implementation of the European Crohn's and Colitis Organization (ECCO/FECCO) Directive and the benefit of the Inflammatory Bowel Disease (IBD) patient's wellness by finding innovative algae based novel small molecule therapeutics. A systemic approach to eco-innovation is adopted to create interconnections between sectors, value chains, natural resources, and relevant societal stewards. To this end, the consortium has set specific objectives to achieve holistic innovations, including technical, economic, health, and social factors that all work in concert. IBD included Crohn's disease and ulcerative colitis. It is a class of chronic inflammatory disorders with complex pathogenesis. Despite the lack of a full understanding of its etiogenesis, many anti-inflammatory treatments have been developed over the last decades. However, not all patients may benefit from these treatments and some of them are refractory to the current therapies or experience relapse of the disease. Therefore, there is still an urgent need to find an innovative line of interventions for ameliorating these patients' overall quality of life. Algae4IBD consortium will form a bridge between innovation and market demands to prevent and treat inflammation, pain, and IBD. Bioactive molecule/compounds extracts from microalgae, cyanobacteria, and macro-algae (MiaCyMa) are an inexhaustible untapped natural source for products destined for IBD prevention and treatment (inflammation, pain, and the disease process associated with the gut's microbiome). The natural source potential is still more promising when considering extremophile strains for excellent metabolism systems. Moreover, the production of the natural source of biological materials should be sustainable. Indeed, the non-genetically modified organisms (GMO cultures offer numerous advantages such as reduced requirements of fresh water and land (no arable land is required), drastic reduction of nitrogen sources, and potential environmental threats. Algae4IBD concept will include a multi-step screening approach and feedback loops across the project steps to achieve its goals. Specifically, DMMBM is in charge with work package (WP) 4, task 4.4.2, which aims to characterize the activity of plant cell (algae) extracts named in this proposal as "natural compounds" of algae provided by the consortium in ex-vivo models, using bioptic samples derived from patients with IBD (patients with ulcerative colitis (UC) and Crohn's disease (CD)), comparing them to samples derived from patients without UC and CD.

NCT ID: NCT06224270 Not yet recruiting - Clinical trials for Inflammatory Bowel Diseases

Study of Response to Zoster Vaccine in Adults With Inflammatory Bowel Disease Treated With Medications

Start date: May 2024
Phase: Phase 4
Study type: Interventional

This multi-center study will evaluate the safety and immune response to recombinant zoster vaccine (RZV) series in 264 patients with inflammatory bowel disease (IBD) on immunosuppressive therapy recruited from 6 study sites who can expect to be on study for up to 14 months.

NCT ID: NCT06090045 Not yet recruiting - IBD Clinical Trials

Airway Involvement In Inflammatory Bowel Disease

Start date: November 20, 2023
Phase:
Study type: Observational

To estimate prevalence of subclinical airway injuries among IBD patients. To investigate relationship between activity of IBD and airways

NCT ID: NCT06089590 Not yet recruiting - Ulcerative Colitis Clinical Trials

Ibd CAncer and seRious Infections in France (I-CARE 2)

I-CARE 2
Start date: November 15, 2023
Phase:
Study type: Observational

This is a French prospective longitudinal observational multicentre cohort study. Primary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.

NCT ID: NCT06042582 Not yet recruiting - IBD Clinical Trials

From Nature to Bedside- Algae Based Bio Compound for Prevention and Treatment of Inflammation, Pain and IBD

Start date: November 1, 2023
Phase:
Study type: Observational

This study is part of the project funded by the Horizon2020 program for establishing the consortium Algae4IBD (https://algae4ibd.eu/), where OSR participates as a partner. It aims to promote the implementation of the European Crohn's and Colitis Organization (ECCO/FECCO) Directive and the benefit of the Inflammatory Bowel Disease (IBD) patient's wellness by finding innovative algae based novel small molecule therapeutics. A systemic approach to eco-innovation is adopted to create interconnections between sectors, value chains, natural resources, and relevant societal stewards. To this end, the consortium has set specific objectives to achieve holistic innovations, including technical, economic, health, and social factors that all work in concert. IBD included Crohn's disease and ulcerative colitis. It is a class of chronic inflammatory disorders with complex pathogenesis. Despite the lack of a full understanding of its etiogenesis, many anti-inflammatory treatments have been developed over the last decades. However, not all patients may benefit from these treatments and some of them are refractory to the current therapies or experience relapse of the disease. Therefore, there is still an urgent need to find an innovative line of interventions for ameliorating these patients' overall quality of life. Algae4IBD consortium will form a bridge between innovation and market demands to prevent and treat inflammation, pain, and IBD. Bioactive molecule/compounds extracts from microalgae, cyanobacteria, and macro-algae (MiaCyMa) are an inexhaustible untapped natural source for products destined for IBD prevention and treatment (inflammation, pain, and the disease process associated with the gut's microbiome). The natural source potential is still more promising when considering extremophile strains for excellent metabolism systems. Moreover, the production of the natural source of biological materials should be sustainable. Indeed, the non-genetically modified organisms (GMO cultures offer numerous advantages such as reduced requirements of fresh water and land (no arable land is required), drastic reduction of nitrogen sources, and potential environmental threats. Algae4IBD concept will include a multi-step screening approach and feedback loops across the project steps to achieve its goals. Specifically, OSR is in charge with work package (WP) 4, task 4.4, which aims to characterize the activity of plant cell (algae) extracts named in this proposal as "natural compounds" of algae provided by the consortium in ex-vivo models, using bioptic samples derived from patients with IBD (patients with ulcerative colitis (UC) and Crohn's disease (CD)), comparing them to samples derived from patients without UC and CD.

NCT ID: NCT05960162 Not yet recruiting - IBD Clinical Trials

Role of 90K/Mac-2 BP as an Indicator of Early Response to Infliximab Therapy in IBD Patients

Start date: July 17, 2023
Phase:
Study type: Observational

The aim of this study is to analyze the relationship between 90K serum levels measured at baseline and after induction in IBD patient undergoing infliximab therapy, in order to clarify the role of serum 90K as an adjuvant biomarker for IBD patients in the active phase. Furthermore, the study aims to evaluate the clinical usefulness of this new biomarker in the management of IBD patients undergoing infliximab therapy.

NCT ID: NCT05771363 Not yet recruiting - IBD Clinical Trials

Frequency and Risk Factors for Autoimmune Disorders and Rheumatic Manifestations in Egyptian Patients With IBD

Start date: April 1, 2023
Phase:
Study type: Observational [Patient Registry]

To examine the prevelance of autoimmune disorders and rheumatic manifestations in egyptian patients with inflammatory bowel diseases,and asses the relation between prevelance of autoimmune disorders ,rheumatic manifestations and disease activity of IBD

NCT ID: NCT05698745 Not yet recruiting - Ulcerative Colitis Clinical Trials

Immunological Characteristics of Preclinical IBD(EARLY)

EARLY
Start date: May 1, 2024
Phase:
Study type: Observational

The purpose of this study is to evaluate disease progression, in terms of development of symptomatic disease and complications associated with IBD (e.g. fistula, abscess, stricture).

NCT ID: NCT05693311 Not yet recruiting - IBD Clinical Trials

Inflammatory Bowel Disease Related Joint Manifestations

Start date: March 1, 2023
Phase:
Study type: Observational

The main purpose of this research is to identify incidence of jiunt manifestations by its both types axial and periphral in IBD patients, its types , relation to IBD activity, lines of treatment using and how they are effective in prevention and in treatment of these joint manifestations.

NCT ID: NCT05689892 Not yet recruiting - Ulcerative Colitis Clinical Trials

Shared Decision Making in Paediatric Inflammatory Bowel Disease

SDM-IBD
Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this mixed-methods prospective cohort study is to assess the impact of shared decision-making (SDM) on newly diagnosed pediatric inflammatory bowel disease (IBD) patients and their families. Patient and familial decisional conflict regarding the choice and course of treatment is shown to be high, especially for the newer class of IBD treatments called biologic agents. SDM intervention comprises of coaching with a decision coach (DC) on all aspects of treatment and care, along with educational decision aids (DA) provided and adapted from Cincinnati Children's Hospital Medical Center. The main aims of this study are: 1. to determine if SDM intervention has an impact on patient and parental decision making in pediatric IBD treatments, mainly by assessing decisional conflict and decision satisfaction/regret. 2. to adapt and assess the acceptability of DA in a Canadian academic center. Participants who have been recommended a new biologic as part of their clinical care for IBD will be recruited to the SDM intervention group. The participants will have DC sessions until a final treatment decision is made, will be given DAs, and will be followed by baseline and post-intervention surveys to assess decisional conflict and satisfaction/regret. The comparator group will include participants who have been recommended and have commenced a new biologic within the last 12 months. Outcome metrics will evaluate the impact on parental and patient decisional conflict following SDM intervention, and decisional satisfaction/regret 6-12 months from therapy start.