Microbiome in the Progression of ALS (MPALS)
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 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 #):
Coordinating Center Contact InformationEmory ALS Center
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:
- Characterize functional status of ALS patients at baseline, +3, and +6 months;
- Characterize changes in gut and oral microbiome for ALS patients and their partner/caregivers at baseline, +3, and +6 months from baseline; and
- 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
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
If you interested in participating in this study, please complete the MPALS study recruitment survey here.
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