wholebiome / NCT03893422

Data-sharing repository for Randomized Clinical Trial NCT03893422 conducted by Pendulum Therapeutics.

NCT03893422

Data-sharing repository for Randomized Clinical Trial NCT03893422 conducted by Pendulum Therapeutics (FKA "Whole Biome, Inc.").

For full details, see our peer-reviewed, open access articles in BMJ Diabetes Research and care:

Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. (2020) 8:e001319. doi: 10.1136/bmjdrc-2020-001319

and in BMC Microbiology:

Increased circulating butyrate and ursodeoxycholate during probiotic intervention in humans with type 2 diabetes. (2022) 22, 19 ISSN: 1471-2180. doi: 10.1186/s12866-021-02415-8

Data

• BMJ 2020: BMJ_DRC_2020_10.1136_bmjdrc-2020-001319/
• BMC 2022: BMC_Microbio_2022_10.1186_s12866-021-02415-8/

Brief Summary

This 16 week placebo-controlled study evaluates the safety and impact of two medical probiotic study products, WBF-010 and WBF-011, consisting of commensal microbes and the dietary fiber, inulin. The primary endpoints were safety, CRP (inflammation), and change in total glucose AUC during meal tolerance test. Change in HbA1c was a secondary endpoint.

Disease: Type 2 Diabetes Mellitus

Intervention/treatment

1. Placebo
2. WBF-010
3. WBF-011

Detailed Description

Targeting the microbiome for treating metabolic syndrome has been gaining traction with multiple population studies demonstrating a difference between healthy individuals and patients with metabolic syndrome. Whole Biome has identified and created two medical food formulations (MFFs) aimed at improving metabolic syndrome via two mechanisms of action targeting the microbiome: (1) increasing butyrate production and (2) increasing mucin regulation.

This randomized, parallel-group, placebo-controlled, double-blinded study assesses the safety and metabolic effects of 2 MFFs on glucose control and the generalized inflammatory state associated with Type 2 Diabetes. The microbes have been fully characterized, certified as Generally Recognized As Safe (GRAS) and manufactured to Good Manufacturing Practice (GMP) standards. The target population was patients with Type 2 Diabetes who either had not been treated with antidiabetic agents or treated with metformin +/- a sulfonylurea. Subjects were randomized in a balanced manner to receive capsules containing placebo, WBF-010 or WBF-011.