NCT06620406Completed
Synbiotic Therapy for NP-PASC
Pilot Study of Synbiotic Therapy for Neuropsychiatric PASC
Source: ClinicalTrials.gov · Last updated 26 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 26 Sept 2024
- Start date
- 9 Dec 2024
- Primary completion date
- 6 Aug 2025
- Lead sponsor
- Columbia University
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06620406
What you commit to
- Study type: Interventional
- Participants enrolled: 36
- From 9 Dec 2024 to the primary completion date, 6 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Heavy drug or alcohol use
- Serious illness requiring systemic treatment and/or hospitalization within 30 prior to study entry
- Any episode of acute or persistent diarrhea within 1 day prior to study entry
Other illness
- Known allergy to any of the study products
- Liver cirrhosis, history of inflammatory bowel disease, or other major conditions related to colon
Other
- Pregnancy or breastfeeding
Who the study is looking for
- \>18 years of age,
- 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
- Meeting Center for Disease Control (CDC) criteria for PASC (any new or recurrent symptom present \>4 weeks after SARS-COV-2 infection)
- 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).
- meets cognitive impairment threshold on neurocognitive battery.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.