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Enrolling By Invitation
NCT07786389
Seaweed Extract (Fucoidan) for Gut Inflammation in Ulcerative Colitis
Conditions: Ulcerative Colitis (UC)
Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 90
Sponsor: Allama Iqbal Medical College
Location: Allama Iqbal Medical college Lahore Punjab Province
Summary
What is the research question being addressed? Does combining Turbinaria ornata-derived fucoidan with standard therapy lead to a significantly higher rate of gut health restoration-defined by increased fecal short-chain fatty acid (butyrate/acetate) levels, reduced fecal calprotectin, and improved stool consistency-compared to standard therapy alone in Ulcerative Colitis patients? Type of study: Interventional Study design: Randomized controlled trial Masking: Participants Control: Placebo Assignment: Parallel Purpose: Other Adjuvant / Add-On Therapy (Complementary Prebiotic Strategy) Study Phase: Phase1
Eligibility Criteria
Inclusion Criteria:
* Male and female patients aged between 18-64 years;
* Active mild to moderate diagnosed cases of uc
* Voluntarily agreeing to participate and providing informed consent.
* Exclusion Criteria:
* Other autoimmune disorders and chronic diseases.
* Patient with Clotting problems.
* Patients using oral/intravenous steroids, leukotriene antagonists, immunosuppressant's, systemic photo chemotherapy, immunotherapy, allergen-specific immunotherapy, or Chinese herbal medicine within one month before enrolment.
* Patient unable to take the trial supplements as scheduled or cooperate in filling out the questionnaire and taking a blood test.
* Patients with a history of allergy
* Patients suffering from serious infection requiring hospitalization assessed by a clinician
* Severe organ dysfunction (e.g., heart failure, liver failure, liver cirrhosis, or renal failure assessed by a clinician.
* Pregnant women or those preparing for pregnancy, and those in lactation.
* Patient with hypothyroidism.
* Patients with a history of allergy to Soy.
* Acute severe (fulminant) UC
Source: ClinicalTrials.gov (NCT07786389). StuddyBuddy aggregates publicly available trial information.