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Placebo-Controlled Clinical Nutrition Study of the Safety and Metabolic Effects of Two Medical Foods in Type 2 Diabetes

NCT03893422 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2020-02-27

No results posted yet for this study

Summary

This 16 week placebo-controlled study evaluates the safety and impact of two medical food study products, WBF10 and WBF11, consisting of commensal microbes. The primary endpoints were safety, glucose AUC during meal tolerance test and C reactive protein (CRP)..

Conditions

Interventions

OTHER

WB-010

Medical food formulation

OTHER

WB-011

WB-011 medical food product

OTHER

Placebo

Placebo Capsules identical to those containing WB-010 and WB-011.

Sponsors & Collaborators

  • Pendulum Therapeutics

    lead INDUSTRY

Principal Investigators

  • Orville G Kolterman, MD · Pendulum Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-22
Primary Completion
2018-08-16
Completion
2018-09-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03893422 on ClinicalTrials.gov