MH002 for Ulcerative Colitis
(StarFish-UC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is evaluating whether a new treatment, MH002 (an experimental treatment), can benefit people with ulcerative colitis (UC), a condition that causes inflammation and sores in the gut. Researchers are testing two different doses of MH002 to determine which is most effective and safest for long-term use. Individuals with mild-to-moderate UC who have had the condition for at least three months and are not responding well to their usual medication might be suitable candidates for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants, offering them a chance to contribute to significant advancements in UC treatment.
Will I have to stop taking my current medications?
The trial requires that you stop using certain medications like sulfasalazine, corticosteroids, antibiotics, prebiotics, probiotics, and some other treatments before joining. However, you can stay on a stable dose of 5-aminosalicylic acid (5-ASA) if you are already taking it.
Is there any evidence suggesting that MH002 is likely to be safe for humans?
Research has shown that MH002 is safe for people. In one study, 45 patients with ulcerative colitis took MH002 and experienced positive results. Another study found that taking 400 mg of MH002 daily for 16 weeks was safe and well-tolerated, with no serious side effects reported during this period.
These findings suggest that MH002 is generally safe, and patients manage the treatment well. The current clinical trial will test different doses to better understand its long-term safety and effectiveness.12345Why do researchers think this study treatment might be promising for ulcerative colitis?
Most treatments for ulcerative colitis, like mesalamine or corticosteroids, work by reducing inflammation in the colon. But MH002 is different because it targets the immune system in a novel way, potentially reducing inflammation more effectively. Researchers are excited about MH002 because it might offer a new option for patients who don't respond well to existing therapies. Additionally, its unique mechanism could provide relief with fewer side effects compared to traditional treatments.
What evidence suggests that MH002 might be an effective treatment for ulcerative colitis?
Research has shown that MH002, a type of beneficial bacteria, may help treat ulcerative colitis. In a previous study with 45 patients, MH002 significantly reduced symptoms and inflammation. Importantly, it proved safe and did not cause harmful side effects. Another study found that stool consistency improved as soon as two weeks into treatment. Overall, evidence suggests MH002 could be effective for people with ulcerative colitis. Participants in this trial will receive either a low dose or high dose of MH002, or a placebo, to further evaluate its effectiveness and safety.12456
Who Is on the Research Team?
Ludo Haazen, MD
Principal Investigator
MRM Health NV
Are You a Good Fit for This Trial?
This trial is for individuals with active Ulcerative Colitis. Participants should have a diagnosis of UC and be in stable condition to receive the treatment. Specific inclusion and exclusion criteria details are not provided, but typically these would cover health status, age range, and possibly previous treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either low-dose or high-dose MH002 or placebo for 12 weeks to assess efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term treatment effects
Investigation of long-term treatment effects of MH002
What Are the Treatments Tested in This Trial?
Interventions
- MH002
Trial Overview
The study tests MH002, a live biotherapeutic product containing bacteria aimed at restoring gut function in UC patients. Two different doses of MH002 will be compared against a placebo to evaluate effectiveness and safety over an extended period.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
MRM Health NV
Lead Sponsor
Citations
P658 Safety and efficacy of MH002, an optimized live ...
MH002 treatment was safe and well tolerated and resulted in clinically meaningful improvements in disease activity and inflammatory parameters.
MRM Health reports data from ulcerative colitis therapy trial
No evidence of adverse reactions was found related to MH002 and stool consistency improved in the MH002 treatment group from week two. At week ...
Confirmatory Clinical Study in Active Ulcerative Colitis
In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects. In this study, 2 different doses will be ...
PRESS RELEASE
MRM Health Reports Positive Topline Results from Phase 2a Clinical Study with MH002 in Mild-to-Moderate Ulcerative Colitis.
SAFETY AND EFFICACY OF MH002, AN OPTIMIZED LIVE ...
Conclusions: MH002 treatment was safe and well tolerated, and resulted in clinically meaningful improvements in disease activity and inflammatory parameters.
6.
mrmhealth.com
mrmhealth.com/docs/MRM%20Health%20announces%20positive%20topline%20data%20Pouchitis_20240416_final.pdfPRESS RELEASE
Met primary endpoint of safety: MH002 was safe and well tolerated with no evidence of adverse reactions when administered for 8 weeks.
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