GI Permeability Change in Response to Aquamin®
NCT04855799 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2025-02-24
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.
Conditions
- Ulcerative Colitis
- Healthy
- Irritable Bowel Syndrome With Diarrhea
Interventions
- DRUG
-
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).
Sponsors & Collaborators
-
James Varani
lead OTHER
Principal Investigators
-
James Varani · University of Michigan
-
Muhammad N Aslam · University of Michigan
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-11-02
- Primary Completion
- 2024-03-11
- Completion
- 2024-03-25
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Effect of Olorinab on Gastrointestinal Transit in Patients With Irritable Bowel Syndrome
NCT04655599 ·Status: TERMINATED ·Phase: PHASE1
-
A Phase 1, First Time in Human (FTIH) Study to Evaluate GSK3352589, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Healthy Volunteers
NCT03154086 ·Status: COMPLETED ·Phase: PHASE1
-
Characterization of Small Molecule Profiles in the Healthy Human Gastrointestinal Tract
NCT05951972 ·Status: COMPLETED ·Phase: NA
-
Intestinal Permeability in Children With Autism Spectrum Disorder
NCT07032857 ·Status: RECRUITING
-
A Phase I, Randomized, Placebo-controlled, Double Blind, Repeat Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Gastrointestinal Transit Time and Pharmacodynamic Biomarkers of GSK3179106 in Normal Subjects
NCT02798991 ·Status: COMPLETED ·Phase: PHASE1
-
A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients
NCT05900752 ·Status: COMPLETED ·Phase: NA
-
Endpoint Determination Study Protocol
NCT03459482 ·Status: COMPLETED ·Phase: NA
-
Hydrogen Breath Test an Instrument to Predict Rifaximin-Response in Irritable Bowel Syndrome Predominant Diarrhea
NCT03729271 ·Status: COMPLETED ·Phase: PHASE4
-
Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial
NCT01908465 ·Status: COMPLETED ·Phase: PHASE4
-
Multi-Strain Probiotics Supplementation With Standard Care in Mild to Moderate Ulcerative Colitis
NCT06595719 ·Status: RECRUITING ·Phase: NA
-
A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
NCT00101725 ·Status: COMPLETED ·Phase: PHASE2
-
Diarrhea Predominant Irritable Bowel Syndrome in Females
NCT00461526 ·Status: COMPLETED ·Phase: PHASE2
-
ConfocAl endomicroSCopy bAsed Diet Trial in IBS
NCT05097872 ·Status: RECRUITING ·Phase: NA
-
Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)
NCT00101985 ·Status: COMPLETED ·Phase: PHASE2
-
Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption
NCT03270085 ·Status: COMPLETED ·Phase: PHASE2
-
Long-term Effects of Arabinoxylans on Intestinal Barrier Function
NCT01877044 ·Status: COMPLETED ·Phase: NA
-
Irritable Bowel Syndrome and Control Volunteers: Diet Challenge
NCT06668922 ·Status: RECRUITING ·Phase: NA
-
Detection of Luminal and Mucosa-associated Microbiome in Healthy Controls vs. Local and Systemic Inflammation
NCT03157687 ·Status: COMPLETED
-
12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)
NCT02107196 ·Status: COMPLETED ·Phase: PHASE3
-
Change in Permeability of the Small Intestine After Treatment With Gluten
NCT02098057 ·Status: COMPLETED ·Phase: NA
-
Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome
NCT00454688 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of DT01 Tablets in Patients With Irritable Bowel Syndrome With Diarrhea
NCT05719896 ·Status: UNKNOWN ·Phase: PHASE2
-
Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
NCT03977155 ·Status: COMPLETED ·Phase: PHASE2
-
Gut Permeability, Sensitivity and Symptomatology
NCT02358564 ·Status: COMPLETED ·Phase: NA
-
Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS
NCT00258193 ·Status: COMPLETED ·Phase: PHASE2