Synbiotic Therapy for NP-PASC (NCT06620406) | Clinical Trial Compass
CompletedNot Applicable
Synbiotic Therapy for NP-PASC
United States36 participantsStarted 2024-12-09
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. \>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.
Exclusion criteria
✕. Pregnancy or breastfeeding
✕. Currently taking or using the following non-study products within 30 days prior to study entry:
✕
What they're measuring
1
Difference in plasma short chain fatty acid (SCFA) levels between study arms
Timeframe: 4 weeks
2
Difference in gut microbiota between study arms
Timeframe: 4 weeks
3
Difference in other biomarkers between study arms
Timeframe: 4 weeks
4
Difference in clinical profiles between study arms