Gut microbiome dysbiosis has been noted in patients with Post-acute sequelae (PASC) ofSevere Acute Respiratory Syndrome-CoronaVirus -2 (SARS-CoV-2). A study performed atColumbia found that plasma levels of the short chain fatty acid (SCFA), butyric acid,remained lower in people with Neuropsychiatric PASC (NP-PASC) than in people with PASCafter SAR-CoV-2 infection. Synbiotics improve SCFA levels and are well-tolerated in thegeneral population but have not been studied among people with PASC in the United States.The purpose of this pilot study is to characterize changes in plasma SCFA levels and gutmicrobiome after treatment with synbiotics and placebo in people with NP-PASC. Theintervention will be a mixture of the prebiotic resistant starch and the probioticBifidobacterium adolescentis in-vivo selection 1 strain (iVS-1). The placebo will beMaltodextrin.
In this pilot study, up to 30 participants with NP-PASC at Columbia University Medical
Center (CUIMC) will be randomized to take the intervention (n=15) or placebo (n=15). Both
intervention and placebo will be similar in terms of appearance and taste, and
participants will be asked to take the intervention or placebo with water twice daily,
for up to 4 weeks. At the enrollment and study follow-up visit, the investigators will
obtain data on acceptability and feasibility, including feasibility of assessing
adherence and outcomes, and collect blood, rectal swabs and stool for outcome assessment.
The study intervention is a mixture of the prebiotic potato RS (Bobs Red Mill) and the
probiotic IVS-1 (Bifidobacterium adolescentis). One dose will be RS and IVS-1 mixed
together in a single-use sachet. The placebo will be Maltodextrin, a carbohydrate,
packaged similarly to the intervention. Participants will take one dose twice daily with
water, for 4 weeks. Each participant will receive a 4-week supply of sachets at the
screening/enrollment visit.
There will be a total of two visits: screening/enrollment/randomization and week 4.
During the screening visit, study information will be provided to potential participants,
and interested participants will sign an informed consent and undergo screening
procedures. Those who meet eligibility criteria will then undergo enrollment and
randomization procedures on the same day. Data on sociodemographic and medical history
will be collected using surveys, and relevant samples will also be collected at the first
visit as well as a self-administered rectal swab, and self-collected stool for gut
microbiome studies and blood test for SCFA levels. The participant will then initiate the
intervention or placebo, and the study staff will counsel and support the participants on
administration of the intervention or placebo. At the 4-week visit, clinical data and
samples will be collected, as well as data on acceptability, feasibility, adherence.
Dietary Supplement: Synbiotic IVS-1
A mixture of the prebiotic potato resistant starch (RS, Bobs Red Mill) and the probiotic
IVS-1 (Bifidobacterium adolescentis).
Other Name: Prebiotic+Probiotic
Dietary Supplement: Maltodextrin
Maltodextrin, a carbohydrate packaged similarly to the study intervention
Inclusion Criteria:
1. >18 years of age,
2. Prior mild acute SARS-CoV-2 infection (positive testing by FDA approved antigen or
molecular test or positive anti-nucleocapsid antibody) and not requiring
hospitalization
3. Meeting Center for Disease Control (CDC) criteria for PASC (any new or recurrent
symptom present >4 weeks after SARS-COV-2 infection)
4. Meeting 2015 Institute of Medicine (IOM) criteria for myalgic
encephalomyelitis/chronic fatigue syndrome (ME-CFS) of 3 required symptoms for
fatigue to select for individuals specifically with NP-PASC (a substantial reduction
or impairment in ability to engage in pre-illness levels of activity,
post-exertional malaise, and unrefreshing sleep) and at least one of the two
following manifestations (cognitive impairment or orthostatic intolerance).
5. meets cognitive impairment threshold on neurocognitive battery.
Exclusion Criteria:
1. Pregnancy or breastfeeding
2. Currently taking or using the following non-study products within 30 days prior to
study entry:
- probiotics, prebiotics, or fiber supplements
- immunosuppressive or immunomodulatory drugs
- antibiotics
3. Heavy drug or alcohol use
4. Known allergy to any of the study products
5. Serious illness requiring systemic treatment and/or hospitalization within 30 prior
to study entry
6. Liver cirrhosis, history of inflammatory bowel disease, or other major conditions
related to colon
7. Any episode of acute or persistent diarrhea within 1 day prior to study entry
Columbia University Irving Medical Center
New York, New York, United States
Investigator: Michael Yin, MD
Contact: 212-305-7185
mty4@cumc.columbia.edu
Michael Yin, MD, MS
212-305-7185
mty4@cumc.columbia.edu
Jayesh Shah
jgs2142@cumc.columbia.edu