Seaweed Extract (Fucoidan) for Gut Inflammation in Ulcerative Colitis
NCT07786389 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-08-26
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
Conditions
- Ulcerative Colitis (UC)
Interventions
- DIETARY_SUPPLEMENT
-
Low molecular weight fucoidan and standard care
LMWF + 5-ASA Arm Oral administration of 85% purified, dehydrogenated low-molecular-weight fucoidan (\<40 kDa) at a weight-based dose (35 mg/kg/day for active flare) as an adjuvant to standard-of-care 5-aminosalicylate therapy.
- OTHER
-
Placebo and standard of care
placebo and 5 Aminosalicylic acid
Sponsors & Collaborators
-
Allama Iqbal Medical College
lead OTHER
Principal Investigators
-
Rozina Shahadat Khan, MBBS, M.PHIL,MSPH, CHPE,PHDHND · Saglik Bilimleri Universitesi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2027-06-30
- Completion
- 2027-12-31
Countries
- Pakistan
Study Locations
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