Seaweed Extract (Fucoidan) for Gut Inflammation in Ulcerative Colitis

NCT07786389 | Enrolling By Invitation Phase 1

• 2 other identifiers: UTN: U1111-1344-9347TERC/EXT/2025/547
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Fucoidan; Gastrointestinal microbiome; Ulcerative; Colitis; Turbinaria; Phaeophyta; Sulfated polysaccharides

Outcome Measures

Primary Outcomes (1)

• Change in intestinal inflammation

  1.Change in intestinal inflammation measured through Quantitative ELISA assay of fecal calprotectin. Mean difference in fecal calprotectin concentration between the Turbinaria ornata fucoidan + standard therapy group and the placebo + standard therapy group, evaluated for a statistically significant reduction toward mucosal healing. \[baseline and wk 12\]

  [baseline and week 12]

Study Arms (2)

5aminosalicilyic acid plus low molecular weight fucoidan

ACTIVE COMPARATOR

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

Dietary Supplement: Low molecular weight fucoidan and standard care

Arm Name: Control Placebo + 5-ASA Identical matching placebo capsule

PLACEBO COMPARATOR

Placebo + 5-ASA Identical matching placebo capsule manufactured to mirror the active Low-Molecular-Weight Fucoidan (LMWF) extract capsule in size, shape, color, weight, texture, and odor as 1 capsule three times daily with meals + conventional Ulcerative Colitis therapy using 5-aminosalycilates.

Other: Placebo and standard of care

Interventions

Low molecular weight fucoidan and standard care DIETARY_SUPPLEMENT

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.

5aminosalicilyic acid plus low molecular weight fucoidan

Placebo and standard of care OTHER

placebo and 5 Aminosalicylic acid

Arm Name: Control Placebo + 5-ASA Identical matching placebo capsule

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allama Iqbal Medical College: lead

Study Sites (1)

Allama Iqbal Medical college

Lahore, Punjab Province, 54590, Pakistan

Location

Related Publications (1)

• Abe, S., Hiramatsu, K., Ichikawa, O., Kawamoto, H., Kasagi, T., Miki, Y., . . . Ikeda, T. (2013). Safety evaluation of excessive ingestion of mozuku fucoidan in human. J Food Sci, 78(4), T648-T651. Abeshu, Y., Abrha, E. J. W. J. o. F. S., & Technology. (2017). Evaluation of Proximate and Mineral Composition Profile for Different Food Barley Varieties Grown in Central High lands of Ethiopia. 1(3), 97-100. Ali, U., Jahangir Anjum, S. A., Erum, H., Hamid, S., & Mir, N. A. (2023). Demographic Profile and Extra Intestinal Manifestations of Ulcerative Colitis in Pakistani population. Pakistan Journal of Medical & Health Sciences, 17(01), 559-559. Aniwan, S., Limsrivilai, J., Pongprasobchai, S., Pausawasdi, N., Prueksapanich, P., Kongtub, N., & Rerknimitr, R. (2021). Temporal trend in the natural history of ulcerative colitis in a country with a low incidence of ulcerative colitis from 2000 through 2018. Intest Res, 19(2), 186-193. Atashrazm, F., Lowenthal, R. M., Woods, G. M., Holloway, A. F., & Dickinson, J. L. (2015). Fucoidan and cancer: A multifunctional molecule with anti-tumor potential. Marine Drugs, 13(4), 2327-2346.

  RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative; Ulcer; Colitis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rozina Shahadat Khan, MBBS, M.PHIL,MSPH, CHPE,PHDHND

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR/HOD COMMUNITY MEDICINE

Model Details: Intervention(s) planned: Arm Name: Active : Marine Polysaccharide Supplement(Low Molecular Weight Fucoidan capsules )+ 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. Arm Name: Control Placebo + 5-ASA Identical matching placebo capsule manufactured to mirror the active Low-Molecular-Weight Fucoidan (LMWF) extract capsule in size, shape, color, weight, texture, and odor as 1 capsule three times daily with meals + conventional Ulcerative Colitis therapy using 5-aminosalycilates.

Study Record Dates

• First Submitted: August 15, 2026
• First Posted: August 26, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)