NCT02483624

A Single-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of 3,3'-Diindolylmethane (BR-DIM) in Patients With Systemic Lupus Erythematosus (SLE)

Terminated Phase 1 Last updated 29 January 2016

What this trial tests

Phase 1 trial testing BR-DIM in SLE in 6 participants. Terminated before completion.

Timeline

1 January 2016

Primary endpoint
1 January 2016

1 January 2016

Quick facts

Lead sponsor	Northwell Health
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	6
Start date	1 January 2016
Primary completion	1 January 2016
Estimated completion	1 January 2016

Drugs / interventions tested

• BR-DIM — full drug profile →
• Placebo

Conditions studied

• SLE — all drugs for SLE →

Sponsor

Northwell Health — full company profile →

Who can join

Adults 18 to 50, female only, with SLE. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety and Tolerability Routine clinical and laboratory parameters as well as SLE activity measurement with SELENA Systemic Lupus Erythematosus Disease Activity Index assessment.
  Time frame: 14 months
  Routine clinical and laboratory parameters as well as SLE activity measurement with SELENA Systemic Lupus Erythematosus Disease Activity Index assessment.
• Estradiol Hydroxylation Pathways
  Time frame: 14 months
  Measure alterations in the ratio of 2-hydroxyestrone/ 16alpha-hydroxyestrone (2-OHE/16alpha-OHE) in the urine.
• Autoantibody Production
  Time frame: 14 Months
  Routine lab testing to determine whether DIM supplementation will decrease autoantibody production
• T and B Lymphocytes
  Time frame: 14 Months
  Qualitative and quantitative abnormalities in B- and T-lymphocytes abound in human SLE. In this aim, phenotypic analyses of B- and T-lymphocyte subsets as well as functional analyses will be ascertained in order to evaluate the effects of DIM on these parameters.

Sponsor's own description

This is a single center study of patients with inactive or mild SLE being performed to determine the safety, tolerability, and pharmacodynamics of DIM.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The path toward using microbial metabolites as therapies.
   Descamps HC, Herrmann B, Wiredu D, Thaiss CA. · · 2019 · cited 77× · PMID 31201140 · DOI 10.1016/j.ebiom.2019.05.063