Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMuhammad N Aslam, MD
About this trial
Ulcerative colitis (UC) is a disease that causes long-term inflammation in the digestive tract, and many people with this condition require surgery to remove the colon and create a new J-pouch for stool. Some patients develop a problem called pouchitis, where this pouch becomes inflamed. Current treatments are limited, and there are no known ways to prevent pouchitis from starting. This study is being done to find out if a natural mineral supplement called Aquamin® can help reduce inflammation and protect the gut lining in people with a J-pouch, and may reduce the risk of pouchitis. By understanding whether Aquamin® is safe and helpful, the study team hopes to find a new and better way to prevent inflammation and improve the long-term health of people with UC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be able to give written informed consent (or assent as appropriate)
Must have the following: UC with ileal pouch-anal anastomosis (IPAA) using a J-pouch without an ileostomy within the last nine months
For pre-menopausal women 18 years of age and older with intact reproductive organs, a negative pregnancy test is required within two weeks prior to the baseline visit. Participants in this age group must agree to use an acceptable form of contraception throughout the study per protocol.
Disqualifiers
Female subjects must not be pregnant or lactating; and female of childbearing potential unwilling to use acceptable birth control throughout the study.
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
History or diagnosis of Crohn's disease
Trial design
Design model
Parallel
Treatments tested in this trial
Aquamin
DrugParticipants will take 2400 milligrams of Aquamin (containing approximately 800 milligrams calcium/day) per day (2 capsules in the morning, two capsules in the evening, or all 4 at one time), oral administration, for 365 days. If participants cannot swallow capsule whole, the capsule may be opened and mixed into liquid or soft food (e.g., water or applesauce) to be consumed. Participants will also take lactulose and mannitol on days day 0, day 180, and day 365 to measure the lactulose:mannitol ratio to assess gastrointestinal permeability.
Placebo
DrugParticipants will take 4 capsules per day; 2 to be taken in the morning and 2 in the evening or all 4 at once. Participants will take this for 365 days. If participants cannot swallow capsule whole, the capsule may be opened and mixed into liquid or soft food (e.g., water or applesauce) to be consumed. Participants will also take lactulose and mannitol on days day 0, day 180, and day 365 to measure the lactulose:mannitol ratio to assess gastrointestinal permeability.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: AquaminExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to clinical onset of pouchitis using the Modified Pouchitis Disease Activity Index (mPDAI) clinical symptoms section
The Modified Pouchitis Disease Activity Index was developed for diagnosing active pouchitis and quantifying the severity of pouchitis. The index includes the clinical criteria of 1) stool frequency 2) rectal bleeding 3) Fecal Urgency/Abdominal Cramps and 4) presence or absence of fever. Scores range from 0-6 (without endoscopic measures). The higher the score, the worse the disease activity.
Time frame
Baseline up to day 365Secondary outcomes
1
Changes in Intestinal permeability assessed by urinary Lactulose/mannitol urinary ratio
Lactulose/mannitol excretion after oral load.
Time frame
Baseline, Approximately Days 180 and 3652
Changes in Serum C-reactive protein (CRP) as marker of inflammation
Blood samples will be drawn for C-reactive protein (CRP) levels.
Time frame
Baseline, Approximately Days 180 and 3653
Changes in Fecal calprotectin (FCAL) as marker of inflammation
Time frame
Baseline, Approximately Days 180 and 365Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Muhammad N Aslam, MD
Lead sponsor
University of Michigan
Sponsor institution
Crohn's and Colitis Foundation
Collaborator
Source ClinicalTrials.gov