Trial Outcomes & Findings for GI Permeability Change in Response to Aquamin® (NCT NCT04855799)

NCT ID: NCT04855799

Last Updated: 2026-07-17

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

Baseline (pre-intervention), 90 days (post-intervention)

Results posted on

2026-07-17

Participant Flow

Recruitment for the IBS-D arm was significantly slower than anticipated. 4 participants were consented. 2 participants withdrew prior to taking the study drug. Of the 2 remaining participants in this arm, only 1 submitted evaluable data before the study closed. This participant's data and, therefore, the IBS-D arm's data was not included in the data analysis for any outcome measure. Also, 2 participants in the healthy arm were determined to be ineligible due to exclusion criteria.

Participant milestones

Participant milestones
Measure	Aquamin® - Healthy Subjects Participants in this arm were healthy participants without Ulcerative Colitis Aquamin: Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).	Aquamin® - Subjects With Ulcerative Colitis Participants in this arm were Ulcerative Colitis patients Aquamin: Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).	Aquamin® - Subjects With IBS-D Participants in this arm were Irritable Bowel Syndrome - D patients Aquamin: Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).
Overall Study STARTED	19	12	4
Overall Study Took initial mannitol solution for baseline sample collection	14	12	3
Overall Study Began taking study drug	13	9	2
Overall Study COMPLETED	12	9	1
Overall Study NOT COMPLETED	7	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Aquamin® - Healthy Subjects Participants in this arm were healthy participants without Ulcerative Colitis Aquamin: Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).	Aquamin® - Subjects With Ulcerative Colitis Participants in this arm were Ulcerative Colitis patients Aquamin: Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).	Aquamin® - Subjects With IBS-D Participants in this arm were Irritable Bowel Syndrome - D patients Aquamin: Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).
Overall Study Withdrawal by Subject	5	3	3
Overall Study Protocol Violation	2	0	0

Baseline Characteristics

GI Permeability Change in Response to Aquamin®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aquamin® - Healthy Subjects n=19 Participants Participants in this arm were healthy participants without Ulcerative Colitis Aquamin: Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).	Aquamin® - Subjects With Ulcerative Colitis n=12 Participants Participants in this arm were Ulcerative Colitis patients Aquamin: Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).	Aquamin® - Subjects With IBS-D n=3 Participants Participants in this arm were Irritable Bowel Syndrome - D patients Aquamin: Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).	Total n=34 Participants Total of all reporting groups
Age, Customized 18 - 21 years	5 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	5 Participants n=5 Participants
Age, Customized 22 - 29 years	3 Participants n=20 Participants	3 Participants n=20 Participants	2 Participants n=40 Participants	8 Participants n=5 Participants
Age, Customized 30 - 39 years	6 Participants n=20 Participants	2 Participants n=20 Participants	0 Participants n=40 Participants	8 Participants n=5 Participants
Age, Customized 40 - 49 years	3 Participants n=20 Participants	4 Participants n=20 Participants	1 Participants n=40 Participants	8 Participants n=5 Participants
Age, Customized 50 - 59 years	2 Participants n=20 Participants	1 Participants n=20 Participants	0 Participants n=40 Participants	3 Participants n=5 Participants
Age, Customized 60 - 69 years	0 Participants n=20 Participants	2 Participants n=20 Participants	0 Participants n=40 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=20 Participants	6 Participants n=20 Participants	1 Participants n=40 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=20 Participants	6 Participants n=20 Participants	2 Participants n=40 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=20 Participants	12 Participants n=20 Participants	3 Participants n=40 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	1 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	13 Participants n=20 Participants	12 Participants n=20 Participants	3 Participants n=40 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=5 Participants
Region of Enrollment United States	19 Participants n=20 Participants	12 Participants n=20 Participants	3 Participants n=40 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pre-intervention), 90 days (post-intervention)

Population: Lactulose:mannitol ratio could not be calculated because lactulose measures could not be generated from the urine samples. The study took place over the COVID-19 pandemic, during which the company that manufactured the ELISA assays for lactulose measurement closed and ceased production. Alternatives to these assays were sought and tested, but none were found to be accurate. Therefore, reliable lactulose measurements could not be taken from urine samples. No data will be analyzed in the future.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 90 days

Population: Data were analyzed from samples that were submitted by participants in the Healthy Subjects and UC arms. Some participants did not submit samples for any time period. One participant did not generate a sample for a single time window. Data from the IBS-D arm was not analyzed due to a lack of usable data.

Though lactulose measurements could not be taken from urine samples, the study team was able to measure mannitol levels in those samples. Higher mannitol levels in urine indicate higher levels of permeability. Participants provided baseline urine samples before drinking a mixture of lactulose/mannitol powder and water. Additional samples were then provided within 0-2 hour window, within a 2-8 hour window, and within an 8-24 hour window of drinking the lactulose/mannitol solution. This test was performed on "day 0" (prior to the participant beginning Aquamin treatment) and day 90 (after the participant had been taking Aquamin for 90 days).

Outcome measures

Outcome measures
Measure	Aquamin® - Healthy Subjects n=8 Participants Participants in this arm were healthy participants without Ulcerative Colitis Aquamin: Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).	Aquamin® - Subjects With Ulcerative Colitis n=8 Participants Participants in this arm were Ulcerative Colitis patients Aquamin: Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).
Mannitol Levels in Urine Samples Baseline - Day 0	68.54 mgs Standard Deviation 85.03	110.35 mgs Standard Deviation 92.70
Mannitol Levels in Urine Samples Baseline - Day 90	106.95 mgs Standard Deviation 86.68	51.60 mgs Standard Deviation 23.30
Mannitol Levels in Urine Samples 0-2 hour window - Day 0	829.14 mgs Standard Deviation 497.29	1277.08 mgs Standard Deviation 503.40
Mannitol Levels in Urine Samples 0-2 hour window - Day 90	978.41 mgs Standard Deviation 455.51	917.63 mgs Standard Deviation 352.46
Mannitol Levels in Urine Samples 2-8 hour window - Day 0	663.69 mgs Standard Deviation 371.03	919.87 mgs Standard Deviation 346.16
Mannitol Levels in Urine Samples 2-8 hour window - Day 90	700.09 mgs Standard Deviation 255.99	681.10 mgs Standard Deviation 390.58
Mannitol Levels in Urine Samples 8-24 hour window - Day 0	229.48 mgs Standard Deviation 126.04	211.04 mgs Standard Deviation 105.25
Mannitol Levels in Urine Samples 8-24 hour window - Day 90	251.99 mgs Standard Deviation 163.70	123.52 mgs Standard Deviation 84.99

Adverse Events

Aquamin® - Healthy Subjects

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Aquamin® - Subjects With Ulcerative Colitis

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Aquamin® - Subjects With IBS-D

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. James Varani

University of Michigan Medical School

Phone: 734-615-0298

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Aquamin® - Healthy Subjects n=14 participants at risk Participants in this arm were healthy participants without Ulcerative Colitis Aquamin: Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).	Aquamin® - Subjects With Ulcerative Colitis n=12 participants at risk Participants in this arm were Ulcerative Colitis patients Aquamin: Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).	Aquamin® - Subjects With IBS-D n=3 participants at risk Participants in this arm were IBS-D patients Aquamin: Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).
Surgical and medical procedures Bone graft surgery for dental implant	0.00% 0/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	8.3% 1/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
General disorders Lactulose/Mannitol related migraine headache	7.1% 1/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
Gastrointestinal disorders Lactulose/Mannitol related diarrhea	0.00% 0/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	8.3% 1/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	33.3% 1/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
Gastrointestinal disorders Nausea	14.3% 2/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	33.3% 1/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
Gastrointestinal disorders Flatulence	35.7% 5/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	8.3% 1/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	33.3% 1/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	33.3% 1/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
General disorders Chest Pain	0.00% 0/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	33.3% 1/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
General disorders Dizziness	7.1% 1/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	33.3% 1/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
Hepatobiliary disorders Hepatobiliary disorders	14.3% 2/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
Hepatobiliary disorders Gilberts disease	7.1% 1/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
Gastrointestinal disorders Abdominal discomfort with bloating	21.4% 3/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	25.0% 3/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
Gastrointestinal disorders Constipation	14.3% 2/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	8.3% 1/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
General disorders Fatigue	0.00% 0/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	8.3% 1/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
Musculoskeletal and connective tissue disorders Joint pain	0.00% 0/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	8.3% 1/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
Gastrointestinal disorders Minor blood in stool with lower abdominal ache	0.00% 0/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	8.3% 1/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
Psychiatric disorders OCD-related distress	7.1% 1/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.
General disorders Tonsil stones	7.1% 1/14 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/12 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.	0.00% 0/3 • Up to 95 days Data is shown for participants who enrolled and were administered at least the baseline mannitol/lactulose solution, regardless of whether or not they continued in the study to take the study drug.