Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcerative Colitis; Ileal Pouch
• Intervention / Treatment: Drug: Aquamin; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lauren Manning; Phone Number: 734-615-7236; Email: lbadish@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
      • Contact: Lauren Manning; Phone Number: 734-615-7236; Email: lbadish@med.umich.edu
      • Principal Investigator: Muhammad N Aslam, MBBS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 eight months
• For pre-menopausal women 11 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.

Exclusion Criteria:

• 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
• History or diagnosis of hereditary gastrointestinal (GI) syndromes, Severe gastrointestinal bleeding/complications, (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin-secreting tumors).
• History or diagnosis of any gastrointestinal malignancy
• Kidney disease, including kidney "stones" or hypercalcemia. acute renal failure (past 12 weeks). (Note: A doubtful stone passed in the urine more than three years ago is not considered evidence of current renal stone disease.)
• Congenital coagulopathies or hereditary hemorrhagic disorders; treatment with therapeutic doses of warfarin or heparin

• Participants will be excluded if they have used any of the following within the past 30 days or are unwilling to withdraw for 30 days prior to entering into the study:

  • Calcium, Magnesium, including multivitamins that have low amounts of Calcium/Magnesium and fiber supplements. (Multivitamins without any minerals are allowed).
  • Non-steroidal anti-inflammatory medications (NSAIDs), such as Naproxen or Ibuprofen (except for occasional pain control or low dose aspirin for cardiovascular disease prevention) per protocol.
  • Oral or rectal 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 (except these can be used briefly during a flare-up once the study treatment has begun after the subject enrolled, if prescribed by the personal physician). Inhaled and skin corticosteroids preparations are ok and not an exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Participants 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.; Other Names: Maltodextrin
Experimental: Aquamin	Drug: Aquamin; Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to day 365

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Intestinal permeability assessed by urinary Lactulose/mannitol urinary ratio	Lactulose/mannitol excretion after oral load.	Baseline, Approximately Days 180 and 365
Changes in Serum C-reactive protein (CRP) as marker of inflammation	Blood samples will be drawn for C-reactive protein (CRP) levels.	Baseline, Approximately Days 180 and 365
Changes in Fecal calprotectin (FCAL) as marker of inflammation		Baseline, Approximately Days 180 and 365

Collaborators and Investigators

• Sponsor: Muhammad N Aslam, MD
• Collaborators: Crohn's and Colitis Foundation
• Investigators: Principal Investigator: Muhammad N Aslam, MBBS, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomization; Placebo; Surveys; Aquamin®; J-pouch without an ileostomy; Sample collection
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; maltodextrin; Aquamin
• Other Study ID Numbers: HUM00284005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No