Aquamin for Ileal Pouchitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a natural mineral supplement called Aquamin® can reduce inflammation and protect the gut in people with ulcerative colitis (UC) who have a J-pouch. Many with UC require surgery to create a J-pouch, and some develop pouchitis, an inflammation of this pouch. The study aims to determine if Aquamin® can prevent pouchitis and improve gut health. Individuals with UC who had a J-pouch surgery within the last eight months might be suitable for this trial. Participants will receive either Aquamin® or a placebo (a substance with no active treatment). As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that Aquamin is likely to be safe for humans?
Research has shown that Aquamin, a natural mineral supplement, is generally safe for use. One study found that participants taking Aquamin experienced positive results without serious side effects. This suggests potential safety for improving gut health, particularly for individuals with ulcerative colitis, a condition causing inflammation in the digestive tract. Participants tolerated the supplement well, and it may help strengthen the gut lining, which is crucial for preventing inflammation. Although further research is necessary, current findings indicate that Aquamin is a promising and safe option for managing gut health.12345
Why do researchers think this study treatment might be promising?
Unlike other treatments for ileal pouchitis, which often include antibiotics or biologic therapies, Aquamin is derived from a natural source—red marine algae. Researchers are excited about this treatment because it is rich in calcium, magnesium, and other trace minerals that may help reduce inflammation naturally. This offers a potentially safer and more holistic alternative to conventional medications, which can have significant side effects. Plus, Aquamin's unique composition might provide additional benefits to gut health, making it a promising option for patients seeking more natural treatment avenues.
What evidence suggests that Aquamin might be an effective treatment for pouchitis?
Research has shown that Aquamin®, a natural mineral supplement, can help reduce gut inflammation. In studies involving individuals with ulcerative colitis, Aquamin® strengthened the gut lining by reducing permeability by 29%. Participants generally tolerated it well, with most experiencing no negative reactions. This trial will evaluate Aquamin® as an experimental treatment for ileal pouchitis, with some participants receiving Aquamin® and others a placebo. These findings suggest that Aquamin® might protect the gut lining and lower the risk of pouchitis, an inflammation of the pouch created during surgery for ulcerative colitis patients. While more research is needed, these early results are promising for those seeking to prevent pouchitis.16789
Who Is on the Research Team?
Muhammad N Aslam, MBBS, MD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Aquamin® or placebo to assess its effect on reducing inflammation and preventing pouchitis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aquamin
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Muhammad N Aslam, MD
Lead Sponsor
Crohn's and Colitis Foundation
Collaborator
Citations
Aquamin® for Prevention of Ulcerative Colitis J-Pouch ...
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 ...
Incidence and Long-Term Outcomes of Pouchitis in ...
Half of the patients with IPAA experienced at least one episode of pouchitis. ASUC did not appear to increase the risk of pouchitis.
A Multi-Mineral Intervention Improves Intestinal ...
Overall, Aquamin® supplementation reduced total post-intervention mannitol excretion by 29% (p = 0.024). Aquamin® was well tolerated, with no ...
(PDF) A Multi-Mineral Intervention Improves Intestinal ...
Overall, Aquamin supplementation reduced total post-intervention mannitol excretion by 29% (p = 0.024). Aquamin was well tolerated, with no ...
Pouchitis unveiled: exploring clinical features, diagnosis, and ...
The results showed that only 10% of the patients treated with VSL#3 experienced an episode of acute pouchitis, compared to 40% in the placebo ...
A Multi-Mineral Intervention Improves Intestinal ...
The intervention was well tolerated, suggesting. Aquamin® may be a safe, promising adjunct for enhancing gut barrier function in UC management.
Inflammatory Pouch Conditions Are Common After ... - PubMed
Conclusions: Inflammatory pouch conditions are common. Biologic use for chronic pouchitis and CDLC does not impact the rate of pouch failure.
Aquamin® for Prevention of Ulcerative Colitis J-Pouch- ...
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- ...
Aquamin® as an Adjuvant Intervention for Ulcerative Colitis
The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will induce remission in patients with ...
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