Synbiotic Therapy for NP-PASC

Description

Gut microbiome dysbiosis has been noted in patients with Post-acute sequelae (PASC) of Severe Acute Respiratory Syndrome-CoronaVirus -2 (SARS-CoV-2). A study performed at Columbia 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 PASC after SAR-CoV-2 infection. Synbiotics improve SCFA levels and are well-tolerated in the general 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 gut microbiome after treatment with synbiotics and placebo in people with NP-PASC. The intervention will be a mixture of the prebiotic resistant starch and the probiotic Bifidobacterium adolescentis in-vivo selection 1 strain (iVS-1). The placebo will be Maltodextrin.

Conditions

Post-Acute COVID-19 Syndrome, Long COVID-19

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Study Overview

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Study Details

Study overview

Gut microbiome dysbiosis has been noted in patients with Post-acute sequelae (PASC) of Severe Acute Respiratory Syndrome-CoronaVirus -2 (SARS-CoV-2). A study performed at Columbia 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 PASC after SAR-CoV-2 infection. Synbiotics improve SCFA levels and are well-tolerated in the general 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 gut microbiome after treatment with synbiotics and placebo in people with NP-PASC. The intervention will be a mixture of the prebiotic resistant starch and the probiotic Bifidobacterium adolescentis in-vivo selection 1 strain (iVS-1). The placebo will be Maltodextrin.

Pilot Study of Synbiotic Therapy for Neuropsychiatric PASC

Synbiotic Therapy for NP-PASC

Condition
Post-Acute COVID-19 Syndrome
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Columbia University,

Michael Yin, MD, MS, PRINCIPAL_INVESTIGATOR, Columbia University

Rupak Shivakoti, PhD, MHS, PRINCIPAL_INVESTIGATOR, Columbia Universtiy Medical Center

Study Record Dates

2025-07-31