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Pendulum D2D Glucose Control for Adults With Type 2 Diabetes

NCT04228003 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-10-07

No results posted yet for this study

Summary

The study is a single site, prospective, open label, observational, single arm trial in 30 patients with type 2 diabetes with GI complaints using 1 or more oral or injectable anti-hyperglycemic agents to investigate if altering the microbiome though Pendulum T2D dietary supplementation can further enhance the efficacy of the current treatment while reducing the GI associated symptoms in patients with Type 2 diabetes.

Conditions

  • Type2 Diabetes
  • Gastrointestinal Symptoms

Interventions

DIETARY_SUPPLEMENT

Pendulum Glucose Control formulation for T2D

All bacteria contained in the study product formulation are commensal organisms that have been repeatedly documented to inhabit the human GI tract under normal circumstances. Pendulum's Glucose Control Formulation consists of five human commensal microbial strains including butyrate producing and mucin-degrading strains. The organisms were grown under controlled conditions consistent with Good Manufacturing Practices (GMP) and employ no animal-derived products. All ingredients utilized during manufacturing were food grade and qualified as generally recognized as safe (GRAS). The product is provided as acid-resistant capsules in bottles that are to be stored refrigerated at 4℃.

Sponsors & Collaborators

  • Pendulum Therapeutics

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Principal Investigators

  • Anne L Peters, MD · University of Southern California

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2022-02-14
Completion
2022-06-14

Countries

  • United States

Study Locations

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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 NCT04228003 on ClinicalTrials.gov