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Researchers are investigating the management of Crohn's disease (CD), a chronic gut inflammation condition. This study focuses on children and young adults aged 6 to 18 years with active CD starting treatment with biologic drugs called TNF alpha inhibitors (infliximab or adalimumab). The study aims to see if replacing part or all of the normal diet with specialized liquid nutrition (milkshakes) for six weeks improves treatment response and helps maintain remission better than continuing the normal diet. Participants will be divided randomly or by choice into groups following their usual diet or replacing varying amounts of it with a liquid diet during the first six weeks of biologic induction therapy. Some participants receiving exclusive enteral nutrition (liquid-only diet) with or without biologics will also be observed for comparison. The study will explore effects on clinical symptoms, biomarker levels, nutrition, body composition, quality of life, immune system markers, and gut and oral microbiomes. During the 10 to 12 weeks of induction therapy, researchers will assess faecal calprotectin and other disease markers to compare improvements in different groups. Follow-up for up to one year will check how many remain symptom-free. Participants will be monitored for nutrition, immune responses, and microbiome changes. The total participation includes initial treatment, follow-up assessments, and observation of long-term treatment effects and remission maintenance.

Age: 6Years - 18YearsAll GendersPhase Not Applicable
6 locations
T

Actively Recruiting

Researchers are investigating colorectal cancer (CRC) patients with newly diagnosed stage I, II, and III cancers to evaluate whether mutations in circulating tumor DNA (ctDNA) can predict disease relapse earlier than current methods. This study includes two parts: Part B focuses on analyzing tumor tissue, serial blood samples, and clinical data to detect minimal residual disease (MRD) and predict relapse, while Part C is a randomized study comparing ctDNA-guided adjuvant chemotherapy to standard care in high-risk stage II or III CRC patients post-surgery. In Part B, the study collects serial blood samples from patients who have undergone potentially curative surgery to detect and quantify ctDNA, aiming to identify MRD and predict relapse. Part C randomizes patients after surgery into two groups: one receiving standard adjuvant chemotherapy and the other receiving ctDNA-guided chemotherapy, where those testing ctDNA negative may have chemotherapy reduced. The goal is to assess if ctDNA-guided treatment can safely reduce chemotherapy use without compromising disease-free survival. Participants will undergo tumor tissue collection, blood sampling at multiple time points, and clinical assessments over several years. Researchers will monitor ctDNA levels and clinical outcomes, measuring disease-free survival up to 3 to 6 years. Safety and treatment effects will be evaluated, with follow-up visits to track relapse and treatment response. Total participation includes long-term monitoring for relapse prediction and chemotherapy guidance.

Age: 18Years +All Genders
71 locations