Using synbiotics to improve gut health in patients with long COVID
Pilot Study of Synbiotic Therapy for Neuropsychiatric PASC
This study is testing if a special combination of prebiotics and probiotics can help improve gut health in people with long COVID symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06620406 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to investigate the effects of synbiotic therapy on patients suffering from Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 (NP-PASC). Participants will be randomized to receive either a mixture of prebiotic resistant starch and probiotic Bifidobacterium adolescentis or a placebo for four weeks. The study will assess changes in plasma levels of short-chain fatty acids and gut microbiome composition, as well as the acceptability and feasibility of the intervention. Data will be collected through blood samples, rectal swabs, and stool analysis at the beginning and end of the study.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have experienced mild COVID-19 and meet specific criteria for NP-PASC.
Not a fit: Patients who are pregnant, breastfeeding, or currently using certain non-study products may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved gut health and symptom relief for patients suffering from long COVID.
How similar studies have performed: While synbiotics have shown promise in other populations, this specific application in NP-PASC is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. \>18 years of age, 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. Meeting Center for Disease Control (CDC) criteria for PASC (any new or recurrent symptom present \>4 weeks after SARS-COV-2 infection) 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. meets cognitive impairment threshold on neurocognitive battery. Exclusion Criteria: 1. Pregnancy or breastfeeding 2. 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 3. Heavy drug or alcohol use 4. Known allergy to any of the study products 5. Serious illness requiring systemic treatment and/or hospitalization within 30 prior to study entry 6. Liver cirrhosis, history of inflammatory bowel disease, or other major conditions related to colon 7. Any episode of acute or persistent diarrhea within 1 day prior to study entry
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Michael Yin, MD, MS — Columbia University
- Study coordinator: Michael Yin, MD, MS
- Email: mty4@cumc.columbia.edu
- Phone: 212-305-7185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.