Based on FDA’s Emergency Guidance, Digbi Health is launching a limited distribution program for its product candidate, Digbi Mental Health
Digbi is currently collaborating with select healthcare providers and academic centers to provide patients with mental health disorders access to the Digbi Cares cognitive behavioral therapy, gut biome and genetics analysis for use in combination with the digital therapeutics program
Digbi Health, an AI-powered, precision digital therapeutics platform that uses gut microbiome and host genetic information, expands its digital health platform to manage several mental health and psychiatric disorders under the FDA’s Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders during the Coronavirus Public Health Emergency.
Digbi Mental Health™ was created to improve the mental health and well-being of members during periods of shelter-in-place, isolation and quarantine and serves as an adjunct to clinician-supervised, outpatient treatment to its members.
A real world study of 275 Digbi Health members reveals clinically significant reductions in Anxiety, Insomnia & Depression symptoms linked to improved gut health. The human gut microbiome has been called a “second brain” because it is responsible for the synthesis and metabolism of critical neurotransmitters and hormones, like serotonin and dopamine, implicating gut health in the so-called gut-brain axis. In fact, it is estimated that 90% of serotonin is made in the digestive tract.
Digbi already takes a forward-thinking approach to mental health, addressing struggles with anxiety, depression and insomnia where they begin – in the gut. Supporting the findings of a Harvard paper on the relationship between your gut, serotonin production and mood, Digbi analyzes ethnic and gender-specific genomics alongside gut microbiome risks and insights to help members improve mental health
The program is now expanded, offering therapy tools and support through the Digbi app and empowering members to take control of their mental health through food, prebiotics, lifestyle and data insights.
“I suffer from depression and just through the change of diet alone, my energy levels are through the roof. My blood pressure is in normal range and my depression seems to have gone away,” shares Jill C., Digbi member, after losing 10 pounds after seven weeks in the Digbi program.
The Real World Study analysis of the members who participated in the Digbi Health program for mental health on an average of 120 days saw a reduction in symptom severity by:
- 65% for those reported suffering from anxiety
- 62% for those reported suffering from depression
- 76% for those reported suffering from insomnia
“While most digital mental health apps manage the symptoms of depression, anxiety, sleep disorders, we help individuals address the root cause of their mental health, which is highly associated with gut health,” said Ranjan Sinha, Founder, and CEO of Digbi Health. “We achieve this by developing a more holistic measure of risk by combining genetics, gut microbiome, clinical data, social determinants of health, and use Food as Medicine to help people sleep better, tackle depression and live less anxious lives.”