Ulcerative Colitis (UC)Phase 1/2SEA-GUTNCT07786389
Seaweed Extract (Fucoidan) for Gut Inflammation in Ulcerative Colitis
A Phase 1/2 study of Ulcerative Colitis (UC), run by Allama Iqbal Medical College at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- Aug 2026to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Brown Algae (Turbinaria Ornata) Derived Fucoidan on Intestinal Inflammation and Gut Health in Ulcerative Colitis Patients
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
Read the detailed description
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.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Low molecular weight fucoidan and standard care, Placebo and standard of care
- Keywords
- Fucoidan, Gastrointestinal microbiome, Ulcerative, Colitis, Turbinaria, Phaeophyta, Sulfated polysaccharides
- Medical subject headings
- Colitis, Ulcerative, Ulcer, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low molecular weight fucoidan and standard careDietary 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.
Placebo and standard of careOther
placebo and 5 Aminosalicylic acid
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Placebo and standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: [baseline and week 12]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allama Iqbal Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Rozina Shahadat Khan, Allama Iqbal Medical College
- Investigators
- Rozina Shahadat Khan, MBBS, M.PHIL,MSPH, CHPE,PHDHND, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786389
- Sponsor's protocol ID
- UTN: U1111-1344-9347
- Other IDs
- UTN: U1111-1344-9347, TERC/EXT/2025/547
- Acronym
- SEA-GUT
- Status last verified
- Jan 2026
- First submitted
- 15 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identify all raw files to protect participant confidentiality before releasing any records.
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Brown Algae (Turbinaria Ornata) Derived Fucoidan on Intestinal Inflammation and Gut Health in Ulcerative Colitis Patients
- ClinicalTrials.gov ID
- NCT07786389
- Acronym / sponsor ID
- SEA-GUT / UTN: U1111-1344-9347
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- Fucoidan, Gastrointestinal microbiome, Ulcerative, Colitis, Turbinaria, Phaeophyta, Sulfated polysaccharides
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Allama Iqbal Medical CollegeUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 5aminosalicilyic acid plus low molecular weight fucoidan | Active comparator | Dietary Supplement: Low molecular weight fucoidan and standard careLMWF + 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 | Placebo comparator | Other: Placebo and standard of carePlacebo + 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low molecular weight fucoidan and standard careLMWF + 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 | 5aminosalicilyic acid plus low molecular weight fucoidan |
| Placebo and standard of careplacebo and 5 Aminosalicylic acid | Other | Arm Name: Control Placebo + 5-ASA Identical matching placebo capsule |
Primary outcome
Change in intestinal inflammation
Time frame: [baseline and week 12]
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]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Results publicationAbe, 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. De-identify all raw files to protect participant confidentiality before releasing any records.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rozina Shahadat Khan, MBBS, M.PHIL,MSPH, CHPE,PHDHND principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Ulcerative Colitis (UC), run by Allama Iqbal Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intestinal inflammation (time frame: [baseline and week 12]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07786389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.