A Phase 2 interventional study of Aquamin® and Placebo first then Aquamin® in Ulcerative Colitis, sponsored by Muhammad N Aslam, MD. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Muhammad N Aslam, MD · Phase 2, Interventional, and Supportive care
The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will induce remission in patients with mild Ulcerative Colitis and extend remission in Ulcerative Colitis in remission.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Muhammad N Aslam, MD is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To be taken for 180 days
Drug: Aquamin®
Placebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover)
Drug: Aquamin® · Drug: Placebo first then Aquamin®
4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)
Also known as: Nutritional
4 capsules per day; 2 to be taken in the morning and 2 in the evening
Also known as: Maltodextrin
Change in ulcerative colitis clinical features / presentation as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) score
This is a self-administered questionnaire. There are 32 quality of life questions related to bowel function. Each response corresponds to a letter 'a' through 'g'. Whereas 'a' indicates high frequency and 'g' indicates minimal frequency. The total IBDQ score ranges between 32 and 224, with higher scores indicating better quality of life.
Time frame: Up to day 180
Change in clinical assessment /gastroenterologist's endoscopic findings based on Ulcerative Colitis Disease Activity Index (UCDAI)/Mayo Scoring
UCDAI/Mayo Scoring consists of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale is scored on a scale of 0 to 3, where 0= normal condition and 3 = severe disease condition. The total Mayo score ranges from 0 to 12, with higher scores indicating more severe disease.
Time frame: Up to day 180
Change in Cytokine levels of the colon tissue as measured by Interleukin 8 (IL-8) levels assessed by enzyme-linked immunosorbent assay (ELISA)
Interleukin 8 levels are measured in picograms per milliliter (pg/mL)
Time frame: Up to day 180
Change in serum C-reactive protein (CRP) levels as measured in a blood sample.
Serum C-reactive protein (\[CRP levels)\] will be reported in milligram per deciliter (mg/dL)
Time frame: Up to day 180
Change in fecal calprotectin levels measured in a stool sample
Fecal calprotectin will be reported in microgram per gram (µg/g)
Time frame: Up to day 180
Changes in serum liver function tests
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALKP) assessment
Time frame: Up to day 180
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Aug 2019 (actual). Primary completion is estimated for Dec 2027, 100 months after the start.
Of 44 non-industry phase 2 interventional studies under Colitis, Ulcerative, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 62. This study's planned 100 months is above that.
Counting every sponsor, half of 153 studies reached it within 28 months; a quarter within 22 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aquamin
Muhammad N Aslam, MD