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Synbiotic Therapy for NP-PASC

NCT06620406 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-08-26

No results posted yet for this study

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.

Conditions

  • Post-Acute COVID-19 Syndrome
  • Long COVID-19

Interventions

DIETARY_SUPPLEMENT

Synbiotic IVS-1

A mixture of the prebiotic potato resistant starch (RS, Bobs Red Mill) and the probiotic IVS-1 (Bifidobacterium adolescentis).

DIETARY_SUPPLEMENT

Maltodextrin

Maltodextrin, a carbohydrate packaged similarly to the study intervention

Sponsors & Collaborators

Principal Investigators

  • Michael Yin, MD, MS · Columbia University

  • Rupak Shivakoti, PhD, MHS · Columbia Universtiy Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-09
Primary Completion
2025-08-06
Completion
2025-08-06

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06620406 on ClinicalTrials.gov