COMPLETED

Synbiotic Therapy for NP-PASC

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Pilot Study of Synbiotic Therapy for Neuropsychiatric PASC

Quick Facts

Study Start:2024-12-09
Study Completion:2025-08-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06620406

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. \>18 years of age,
  2. 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. 3. Meeting Center for Disease Control (CDC) criteria for PASC (any new or recurrent symptom present \>4 weeks after SARS-COV-2 infection)
  4. 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. 5. meets cognitive impairment threshold on neurocognitive battery.
  1. 1. Pregnancy or breastfeeding
  2. 2. Currently taking or using the following non-study products within 30 days prior to study entry:
  3. * probiotics, prebiotics, or fiber supplements
  4. * immunosuppressive or immunomodulatory drugs
  5. * antibiotics
  6. 3. Heavy drug or alcohol use
  7. 4. Known allergy to any of the study products
  8. 5. Serious illness requiring systemic treatment and/or hospitalization within 30 prior to study entry
  9. 6. Liver cirrhosis, history of inflammatory bowel disease, or other major conditions related to colon
  10. 7. Any episode of acute or persistent diarrhea within 1 day prior to study entry

Contacts and Locations

Principal Investigator

Michael Yin, MD, MS
PRINCIPAL_INVESTIGATOR
Columbia University
Rupak Shivakoti, PhD, MHS
PRINCIPAL_INVESTIGATOR
Columbia Universtiy Medical Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Columbia University

  • Michael Yin, MD, MS, PRINCIPAL_INVESTIGATOR, Columbia University
  • Rupak Shivakoti, PhD, MHS, PRINCIPAL_INVESTIGATOR, Columbia Universtiy Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-09
Study Completion Date2025-08-06

Study Record Updates

Study Start Date2024-12-09
Study Completion Date2025-08-06

Terms related to this study

Additional Relevant MeSH Terms

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