Synbiotic Therapy for NP-PASC

NCT06620406 | Completed

• 1 other identifier: AAAV3630
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Difference in plasma short chain fatty acid (SCFA) levels between study arms

  SCFA levels will be measured from plasma samples and compared between the intervention group and the placebo group. In-group differences will also be measured between baseline and 4 weeks.

  4 weeks

• Difference in gut microbiota between study arms

  Bacterial flora will be measured from rectal swab samples and compared between the intervention group and the placebo group. In-group differences will also be measured between baseline and 4 weeks.

  4 weeks

• Difference in other biomarkers between study arms

  Additional biomarkers, such as serotonin and inflammatory cytokines, measured from the plasma samples and rectal swabs, whose concentration will be compared between the intervention group and the placebo group, and in-group differences between timepoints. Additional biomarkers include, but are not limited to, inflammatory cytokines and serotonin.

  4 weeks

• Difference in clinical profiles between study arms

  Survey data will be compared between the intervention group and the placebo group, and in-group differences between timepoints. Survey data includes, but is not limited to, medication, COVID History, Vaccine History, and Medical History.

  4 weeks

Secondary Outcomes (3)

• Number of participants enrolled per week and agree to take the intervention

  4 weeks

• Number of participants who successfully take the intervention

  4 weeks

• Difference in NP-PASC symptoms between study arms

  4 weeks

Study Arms (2)

Synbiotic Therapy

EXPERIMENTAL

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

Dietary Supplement: Synbiotic IVS-1

Placebo

PLACEBO COMPARATOR

The placebo to be used is Maltodextrin, a carbohydrate packaged similarly to the study intervention.

Dietary Supplement: Maltodextrin

Interventions

Synbiotic IVS-1 DIETARY_SUPPLEMENT

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

Also known as: Prebiotic+Probiotic

Synbiotic Therapy

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin, a carbohydrate packaged similarly to the study intervention

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• Pregnancy or breastfeeding
• 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
• Known allergy to any of the study products
• Serious illness requiring systemic treatment and/or hospitalization within 30 prior to study entry
• Liver cirrhosis, history of inflammatory bowel disease, or other major conditions related to colon
• Any episode of acute or persistent diarrhea within 1 day prior to study entry

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (7)

• Liu Q, Mak JWY, Su Q, Yeoh YK, Lui GC, Ng SSS, Zhang F, Li AYL, Lu W, Hui DS, Chan PK, Chan FKL, Ng SC. Gut microbiota dynamics in a prospective cohort of patients with post-acute COVID-19 syndrome. Gut. 2022 Mar;71(3):544-552. doi: 10.1136/gutjnl-2021-325989. Epub 2022 Jan 26.

  PMID: 35082169 BACKGROUND

• Kearney SM, Gibbons SM, Erdman SE, Alm EJ. Orthogonal Dietary Niche Enables Reversible Engraftment of a Gut Bacterial Commensal. Cell Rep. 2018 Aug 14;24(7):1842-1851. doi: 10.1016/j.celrep.2018.07.032.

  PMID: 30110640 BACKGROUND

• Pandey KR, Naik SR, Vakil BV. Probiotics, prebiotics and synbiotics- a review. J Food Sci Technol. 2015 Dec;52(12):7577-87. doi: 10.1007/s13197-015-1921-1. Epub 2015 Jul 22.

  PMID: 26604335 BACKGROUND

• Maldonado-Gomez MX, Martinez I, Bottacini F, O'Callaghan A, Ventura M, van Sinderen D, Hillmann B, Vangay P, Knights D, Hutkins RW, Walter J. Stable Engraftment of Bifidobacterium longum AH1206 in the Human Gut Depends on Individualized Features of the Resident Microbiome. Cell Host Microbe. 2016 Oct 12;20(4):515-526. doi: 10.1016/j.chom.2016.09.001. Epub 2016 Sep 29.

  PMID: 27693307 BACKGROUND

• Sonnenburg ED, Smits SA, Tikhonov M, Higginbottom SK, Wingreen NS, Sonnenburg JL. Diet-induced extinctions in the gut microbiota compound over generations. Nature. 2016 Jan 14;529(7585):212-5. doi: 10.1038/nature16504.

  PMID: 26762459 BACKGROUND

• Committee on the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome; Board on the Health of Select Populations; Institute of Medicine. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness. Washington (DC): National Academies Press (US); 2015 Feb 10. Available from http://www.ncbi.nlm.nih.gov/books/NBK274235/

  PMID: 25695122 BACKGROUND

• Grooms KN, Ommerborn MJ, Pham DQ, Djousse L, Clark CR. Dietary fiber intake and cardiometabolic risks among US adults, NHANES 1999-2010. Am J Med. 2013 Dec;126(12):1059-67.e1-4. doi: 10.1016/j.amjmed.2013.07.023. Epub 2013 Oct 15.

  PMID: 24135514 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Yin, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

• Rupak Shivakoti, PhD, MHS

  Columbia Universtiy Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: December 9, 2024
• Primary Completion: August 6, 2025
• Study Completion: August 6, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)