Microbiota Transplant Therapy for Alopecia Areata
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach called Microbiota Transplant Therapy (MTT) to treat alopecia areata, a condition where the immune system attacks hair follicles, causing hair loss. The goal is to determine if changes in gut bacteria can influence hair regrowth and immune response. Participants will receive either the MTT treatment or a placebo for comparison. The trial seeks individuals with moderate to severe alopecia areata for at least three months without signs of hair regrowth. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
Yes, if you are taking a JAK inhibitor or other medications that affect hair regrowth, you will need to stop them for at least one month before joining the trial and throughout its duration.
Is there any evidence suggesting that Microbiota Transplant Therapy is likely to be safe for humans?
Research has shown that microbiota transplant therapy (MTT) is generally safe. In one study, patients with alopecia universalis, a severe type of hair loss, experienced hair regrowth after receiving a fecal microbiota transplant (FMT) for a different condition. This suggests potential benefits without major safety issues. Another study on FMT for psoriatic arthritis found it to be safe, although not more effective than a placebo.
These findings indicate that MTT is usually well-tolerated, with no serious side effects reported. However, its effectiveness for treating alopecia areata remains under investigation. As this trial is in an early stage, further research is needed to fully understand its safety and effectiveness for hair loss.12345Why do researchers think this study treatment might be promising for alopecia areata?
Unlike the standard treatments for alopecia areata, which typically include corticosteroids and immunotherapy, Microbiota Transplant Therapy (MTT) offers a novel approach by targeting the gut microbiome. Researchers are excited about this treatment because it uses an oral capsule to introduce beneficial bacteria, potentially resetting the immune system and reducing inflammation, which are key factors in hair loss. This innovative mechanism of action makes MTT a promising alternative, particularly for those who haven't responded well to traditional therapies.
What evidence suggests that Microbiota Transplant Therapy might be an effective treatment for Alopecia Areata?
Research has shown that microbiota transplant therapy (MTT), which participants in this trial may receive, might help treat alopecia areata (AA), a condition where the immune system attacks hair follicles, causing hair loss. In 2017, two patients with a severe form of AA, called alopecia universalis, grew back hair after receiving a fecal microbiota transplant (FMT) for a different health issue. This suggests a possible connection between gut health and hair regrowth. Additionally, studies have found that the gut microbiome, the community of bacteria and other microorganisms in the digestive system, can affect the development of AA. Thus, altering gut bacteria might help manage or even reverse hair loss in people with AA.23456
Who Is on the Research Team?
Maria K Hordinsky, MD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for individuals with alopecia areata, including patchy hair loss, total scalp baldness, or complete body hair loss. Participants must have had hair loss for at least 3 months without signs of regrowth. Women who can have children need a negative pregnancy test and must use birth control. Those on JAK inhibitors must stop them before and during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive antibiotics and MTT oral capsule or placebo for the control group
Follow-up
Participants are monitored for safety and effectiveness after treatment, including hair regrowth and microbiota engraftment
Long-term follow-up
Participants are monitored for relapse and safety outcomes up to 12 months post therapy
What Are the Treatments Tested in This Trial?
Interventions
- Microbiota Transplant Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Columbia University
Collaborator