Healthy, Irritable Bowel Syndrome With Diarrhea, Ulcerative Colitis
Conditions
Keywords
gastrointestinal permeability
Brief summary
This trial is being completed to learn about how Aquamin® affects gastrointestinal permeability, or the control of material passing from inside the gastrointestinal tract through the gut wall into the rest of the body, in people with ulcerative colitis (UC), Irritable Bowel Syndrome with diarrhea (IBS-D), and in healthy individuals.
Detailed description
This is a sub-study to the ongoing clinical trial entitled: Aquamin®, a multi-mineral natural product from red marine algae, as an adjuvant intervention for mild ulcerative colitis and ulcerative colitis in remission (HUM00156676) NCT# NCT03869905.
Interventions
DRUGAquamin
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).
Sponsors
James Varani
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
for UC participants: * Must be able to give written informed consent * Age 18 to 80 years old. * Must have: Ulcerative colitis with confirmed diagnosis by histology and endoscopy; and be in stable remission for 3 months or more without therapy or with maintenance therapy (except steroids and antibiotics for 3 months) or have mild ulcerative colitis. Note: Corticosteroids (a type of steroid drug such as prednisone or cortisol that helps the body to regulate stress response, immune response and inflammation) and antibiotics can be used during a flare-up once the study has begun and the subject enrolled. * A negative pregnancy test for pre-menopausal women with intact female reproductive organs. Must agree to use appropriate birth control over the study period (if applicable). If cessation of menses is within 12 months, then the participant will be treated as pre-menopausal and a pregnancy test will be performed. Inclusion Criteria for Healthy participants: * Must be able to give written informed consent * Be generally healthy, male or female, ages 18 to 80 years old. * Pre-menopausal women with intact female reproductive organs must have a negative pregnancy test within 2 weeks of the Baseline Visit. * Subject must agree to use appropriate birth control over the study period. (Post-menopausal is defined as no menses for the previous 12 months. If cessation of menses is within 12 months, then the participant will be treated as pre-menopausal and a pregnancy test will be performed. Inclusion Criteria for participants with IBS-D: * Patients with ages 18-80 years old. * Must meet the IBS-D Diagnostic Rome IV (four) Criteria as noted in the protocol * A negative pregnancy test for pre-menopausal cis-women with intact vagina, uterus, and/or ovaries. The negative pregnancy test must be within 2 weeks of the baseline visit and the subject must agree to use appropriate birth control over the study period.
Exclusion criteria
For UC participants: * Must not be pregnant or lactating * Must not be participating in any other interventional trial using an investigational drug. * Subjects likely to be uncooperative or unable to comply with study procedures * Participants must not be felt to have active ulcerative colitis for 3 months before study enrollment (with an exception of mild ulcerative colitis). * Participants must not have a history or diagnosis of any of the following conditions: Crohn's disease, Any stomach or intestinal bleeding disorders (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors) or active gastric/duodenal ulcers - peptic ulcer disease (without bleeding in last 3 months). * Must not have any gastrointestinal or colonic malignancy. * Must not have Kidney disease, including kidney "stones" or hypercalcemia. * Must not have Coagulopathy/hereditary hemorrhagic disorders * Participants will be excluded if they have taken certain medications (per protocol), within the last 30 days or are unwilling to forgo the following for 30 days prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Lactulose:Mannitol Ratio in Urine by Comparing Values at 90-days (Post-intervention) to Baseline (Pre-intervention) Levels. | Baseline (pre-intervention), 90 days (post-intervention) | — |
| Mannitol Levels in Urine Samples | 90 days | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJames Varani
University of Michigan
STUDY_DIRECTORMuhammad N Aslam
University of Michigan
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 18 - 21 years | 5 Participants |
| Age, Customized 22 - 29 years | 8 Participants |
| Age, Customized 30 - 39 years | 8 Participants |
| Age, Customized 40 - 49 years | 8 Participants |
| Age, Customized 50 - 59 years | 3 Participants |
| Age, Customized 60 - 69 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants |
| Race/Ethnicity, Customized White | 28 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 12 | 0 / 3 |
| other Total, other adverse events | 7 / 14 | 6 / 12 | 3 / 3 |
| serious Total, serious adverse events | 0 / 14 | 0 / 12 | 0 / 3 |
Outcome results
None listed