30 Participants Needed

Synbiotic Therapy for Long COVID Syndrome

MY
JS
Overseen ByJayesh Shah

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking probiotics, prebiotics, fiber supplements, immunosuppressive or immunomodulatory drugs, and antibiotics at least 30 days before joining the study.

What data supports the effectiveness of the treatment Synbiotic IVS-1 for Long COVID Syndrome?

Research shows that synbiotic treatments, which combine probiotics (good bacteria) and prebiotics (food for these bacteria), can help reduce inflammation in COVID-19 patients and improve gut health, which may be beneficial for Long COVID symptoms.12345

Is Synbiotic Therapy for Long COVID Syndrome safe for humans?

The synbiotic therapy, which includes various probiotics and prebiotics, has been tested in studies with COVID-19 patients and showed no significant safety concerns. It was generally well-tolerated, with no major side effects reported, indicating it is likely safe for human use.12367

How is Synbiotic IVS-1 treatment different from other treatments for Long COVID?

Synbiotic IVS-1 is unique because it combines probiotics (beneficial bacteria) and prebiotics (food for these bacteria) to help restore gut health, which may improve immune function and reduce inflammation. This approach is different from other treatments that do not focus on gut microbiota modulation.12348

What is the purpose of this trial?

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.

Research Team

RS

Rupak Shivakoti, PhD, MHS

Principal Investigator

Columbia Universtiy Medical Center

MY

Michael Yin, MD, MS

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for individuals experiencing long-term symptoms after COVID-19, known as Post-COVID Syndrome or Long COVID. Participants should have neuropsychiatric symptoms and will be assessed to ensure their condition aligns with the study's focus on gut health related to post-COVID recovery.

Inclusion Criteria

I experience severe fatigue, unrefreshing sleep, and worsen after physical or mental activity.
I am older than 18 years.
I have long-term symptoms from COVID-19 lasting more than 4 weeks.
See 2 more

Exclusion Criteria

Pregnancy or breastfeeding
I am not currently using probiotics, immunosuppressives, or antibiotics.
Heavy drug or alcohol use
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Participants receive either the synbiotic therapy or placebo for 4 weeks

4 weeks
1 visit (in-person) at week 4

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Synbiotic IVS-1
Trial Overview The trial is testing Synbiotic IVS-1—a combination of a prebiotic (resistant starch) and a probiotic (Bifidobacterium adolescentis strain iVS-1)—against Maltodextrin, which serves as a placebo. The goal is to see if Synbiotic IVS-1 can improve gut health by increasing beneficial fatty acids in people with Long COVID.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Synbiotic TherapyExperimental Treatment1 Intervention
A mixture of the prebiotic potato resistant starch (RS, Bobs Red Mill) and the probiotic IVS-1 (Bifidobacterium adolescentis).
Group II: PlaceboPlacebo Group1 Intervention
The placebo to be used is Maltodextrin, a carbohydrate packaged similarly to the study intervention.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Findings from Research

In a randomized placebo-controlled trial involving 78 hospitalized COVID-19 patients, synbiotic supplementation significantly reduced serum levels of the pro-inflammatory marker interleukin-6 (IL-6) after 2 weeks, suggesting its potential to modulate inflammatory responses during COVID-19 infection.
The synbiotic group also showed a significant increase in white blood cell (WBC) counts from pre to post-treatment, indicating an immune response, although other inflammatory markers like C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) did not show significant differences compared to the placebo.
The effect of synbiotic adjunct therapy on clinical and paraclinical outcomes in hospitalized COVID-19 patients: A randomized placebo-controlled trial.Vaezi, M., Ravanshad, S., Akbari Rad, M., et al.[2023]
In a study involving 25 hospitalized COVID-19 patients, the synbiotic formula SIM01 significantly improved antibody response against SARS-CoV-2, with 88% of patients developing IgG antibodies compared to 63.3% in the control group by Day 16.
Patients receiving SIM01 also showed reduced levels of pro-inflammatory markers and a significant decrease in nasopharyngeal viral load, indicating that this synbiotic may help restore gut health and improve immune responses in COVID-19 patients.
Gut microbiota-derived synbiotic formula (SIM01) as a novel adjuvant therapy for COVID-19: An open-label pilot study.Zhang, L., Xu, Z., Mak, JWY., et al.[2022]
In a randomized, double-blind, placebo-controlled trial involving 463 patients with post-acute COVID-19 syndrome (PACS), the synbiotic preparation SIM01 significantly alleviated symptoms such as fatigue, memory loss, and difficulty in concentration after 6 months of treatment.
The safety profile of SIM01 was comparable to placebo, with similar rates of adverse events, suggesting it is a safe option for managing PACS symptoms through modulation of the gut microbiome.
A synbiotic preparation (SIM01) for post-acute COVID-19 syndrome in Hong Kong (RECOVERY): a randomised, double-blind, placebo-controlled trial.Lau, RI., Su, Q., Lau, ISF., et al.[2023]

References

The effect of synbiotic adjunct therapy on clinical and paraclinical outcomes in hospitalized COVID-19 patients: A randomized placebo-controlled trial. [2023]
Gut microbiota-derived synbiotic formula (SIM01) as a novel adjuvant therapy for COVID-19: An open-label pilot study. [2022]
A synbiotic preparation (SIM01) for post-acute COVID-19 syndrome in Hong Kong (RECOVERY): a randomised, double-blind, placebo-controlled trial. [2023]
Oral booster probiotic bifidobacteria in SARS-COV-2 patients. [2022]
Nutritional Modulation of Gut Microbiota Alleviates Severe Gastrointestinal Symptoms in a Patient with Post-Acute COVID-19 Syndrome. [2022]
Efficacy of a Probiotic Consisting of Lacticaseibacillus rhamnosus PDV 1705, Bifidobacterium bifidum PDV 0903, Bifidobacterium longum subsp. infantis PDV 1911, and Bifidobacterium longum subsp. longum PDV 2301 in the Treatment of Hospitalized Patients with COVID-19: a Randomized Controlled Trial. [2023]
7.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Efficiency of application of sorbed probiotics in complex therapy of pneumonia caused by SARS-CoV-2. Part 1. Heating clinical displays period]. [2022]
Modulation of Gut Microbiota for the Prevention and Treatment of COVID-19. [2021]
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