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 Nature’s Bounty) and the product was no longer commercially available. Efforts to identify additional supply were unsuccessful. Although Nature’s 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. The study was closed to enrollment in August 2021 and data analysis is ongoing. The collected data has provided valuable information on the feasibility and acceptability of the microbiome modulator in youth with type 2 diabetes who are treated with metformin. The manuscript was published in 2022 (PMID: 36909343). These pilot data are foundational for designing the larger planned trial of microbial modulation in the treatment of diabetes and obesity in youth. Exploratory analyses to demonstrated that metformin was detectable in the stool but there were no other unique signatures observed in the stool. Study findings were peer-reviewed and published.