A Phase 1/2 interventional study of Low molecular weight fucoidan and standard care and Placebo and standard of care in Ulcerative Colitis (UC), sponsored by Allama Iqbal Medical College. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Allama Iqbal Medical College · Phase 1/2, Interventional, and Other
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
Intervention Efficacy \& Evidence Status Whether combining Turbinaria ornata-derived fucoidan with standard therapy leads to a statistically significant increase in gut health restoration in human Ulcerative Colitis (UC) patients remains an unproven hypothesis, as robust Phase II/III clinical trial data in humans is currently lacking.
Preclinical animal models (such as DSS-induced colitis in mice) and in vitro fermentation models support the biological rationale for this combination:
Fecal Short-Chain Fatty Acids (SCFAs): Marine sulfated polysaccharides (fucoidans) act as prebiotic non-digestible carbohydrates. Commensal anaerobic gut bacteria ferment fucoidan, leading to an increase in butyrate, acetate, and propionate levels.
Fecal Calprotectin: Fucoidan suppresses the NF-κB and MAPK signaling pathways, decreasing pro-inflammatory cytokines (TNF-α, IL-6, IL-1β), reducing mucosal neutrophil infiltration, and subsequently lowering fecal calprotectin.
Stool Consistency: Through structural restoration of epithelial tight junctions (ZO-1, Claudin-1) and mucin protection (MUC2), fucoidan mitigates mucosal erosion and diarrhea, improving stool consistency scores.
Classification of the Intervention Intervention Category: Adjuvant / Add-On Therapy (Complementary Prebiotic Strategy)
Sub-type: Natural Product-derived Bioactive / Marine Polysaccharide Supplement
Mechanistic Role: Co-administered with standard pharmacotherapy (e.g., 5-aminosalicylates like Mesalamine, corticosteroids, or biologics) to target mucosal healing and gut dysbiosis concurrently with immune suppression. Phase IIa (Proof-of-Concept) is the most appropriate trial classification for testing Turbinaria ornata-derived fucoidan in Ulcerative Colitis (UC). Because oral fucoidan preparations have a recognized history of human use for other indications (such as osteoarthritis, oncological adjuncts, and metabolic health), its basic systemic safety and human oral tolerance are already documented. However, because it has never been evaluated in human UC populations.
Primary Reasons for Phase IIa RecommendationEvaluating Disease-Specific Mucosal Safety: Ulcerative Colitis involves an inflamed, ulcerated, and hyper-permeable mucosal barrier. Even though fucoidan is safe in intact human guts, its local tolerance, systemic absorption rates, and safety profile must be confirmed specifically in patients with active mucosal friability. Determining Biological Proof-of-Concept: Phase IIa focuses on demonstrating that the drug hits its intended targets using surrogate biomarkers. Measuring fecal calprotectin reduction and changes in fecal SCFA (butyrate/acetate) levels provides objective evidence that the bioactive agent is exerting its anti-inflammatory and prebiotic effects in human UC. Preliminary Efficacy Signals: A Phase IIa design allows to observe preliminary clinical signal (stool consistency via the Bristol Stool Chart / Partial Mayo Score) before investing in large-scale multicenter Phase IIb/III randomized controlled trials.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 90 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Allama Iqbal Medical College is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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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
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
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.
placebo and 5 Aminosalicylic acid
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. \[baseline and wk 12\]
Time frame: [baseline and week 12]
Plan to share: No — De-identify all raw files to protect participant confidentiality before releasing any records.
Start is estimated for Aug 2026; primary completion for Jun 2027, 10 months later.
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Allama Iqbal Medical College