Prebiotics and Metformin Influences Gut and Hormones in Type 2 Diabetes Youth (MIGHTY-Fiber)

National Institute Of Diabetes And Digestive And Kidney Diseases

Investigators

Abstract

Study recruitment began in earnest in February 2020 and was on schedule. However, in March 2020, due to the COVID-19 pandemic, recruitment and protocol procedures were significantly delayed. All study visits were placed on hold on March 13th and recruitment and protocol execution resumed August 2020. In total, we have completed 9 screenings at the NIH Clinical Center and enrolled and studied 6 participants. In addition, in June 2020, we were notified that the study agent supplier company (Microbiome Therapeutics) was sold (to Natures Bounty) and the product was no longer commercially available. Efforts to identify additional supply were unsuccessful. Although Natures Bounty will consider marketing a similar product in Fall 2021, this product is not biosimilar to the study agent used in our MIGHTY Fiber protocol. Additional enrollment was paused in July 2021, because the study agent expired on July 31, 2021. As such, we are unable to continue study procedures and changed the study status to data analysis only. The collected data will provide critical information on the feasibility and efficacy of microbiome modulator in youth with type 2 diabetes who are treated with metformin. There has been one abstract that is related to this protocol since approval in December 2019. The abstract entitled Prebiotics for Mitigating Metformin Induced Gastrointestinal Side Effects in Youth with Type 2 Diabetes was presented at the NIH Summer Research Day August 2021.