Microbiome in the Progression of ALS (MPALS)

Study Purpose:

The purpose of this study is to characterize the oral and intestinal microbiome in ALS patients and their partners at baseline (early after diagnosis) and longitudinally at 3 and 6 months.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Observational Study

Study Category:

Epidemiology

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Vicki Hertzberg, PhD (Emory University)
Jonathan Glass, MD (Emory University)
Christina Fournier, MD, MSc (Emory University)

Clinicaltrials.gov ID (11 digit #):

Neals Affiliated?

No

Coordinating Center Contact Information

Emory ALS Center
Karon Simmons / .(JavaScript must be enabled to view this email address) / (404) 712-4182
.(JavaScript must be enabled to view this email address) 101 Woodruff Circle
Suite 6000
Atlanta, Georgia 30322 United States

Full Study Summary:

The goal of the Microbiome in the Progression of ALS project is to quantify associations of structure and dynamics of microbiome profiles with change in function over six months during the first year post-diagnosis in recently diagnosed ALS patients as measured by ALSFRS-R and to compare these  microbiome profiles to those of partner/caregiver controls. We propose to identify particular species and strains of microbes deficient in ALS patients such that replenishment of these microbes might slow disease progression or those that may be deleterious, providing a therapeutic target. We will recruit a cohort of 30 ALS patients and their partner/caregiver controls within 6 months of diagnosis, examining them at enrollment and at +3 and +6 months to accomplish the following specific aims:

  1. Characterize functional status of ALS patients at baseline, +3, and +6 months;
  2. Characterize changes in gut and oral microbiome for ALS patients and their partner/caregivers at baseline,  +3, and +6 months from baseline; and
  3. Exploratory Aim: Whole genome sequence DNA stored from pilot study samples to better understand bacterial species/strains, viruses, and fungi, that may play a role in ALS progression.

Study Sponsor:

The ALS Association

Participant Duration:

None

Estimated Enrollment:

30 couples

Estimated Study Start Date:

08/01/2020

Estimated Study Completion Date:

Posting Last Modified Date:

Date Study Added to alsconsortium.org:

08/16/2021
  • More Information

    If you interested in participating in this study, please complete the MPALS study recruitment survey here.

  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    <18 months

    Time since Diagnosis:

    <12 months

    Can participants use Riluzole?

    Yes


    Symptom onset must be 12 months of date of diagnosis. Date of diagnosis must be within 6 months of site contact. Can not take antibiotics. Receiving nutrition orally (no feeding tube).

  • Site Contact Information

    Emory ALS Center
    Karon Simmons / .(JavaScript must be enabled to view this email address) / 404-712-4182.
    101 Woodruff Circle
    Atlanta, GA 30322
    United States