COVID-19 Pneumonia and Gut Inflammation

COVID-19 Pneumonia and Gut Inflammation: The Role of a Mix of Three Probiotic Strains in Reducing Inflammatory Markers and Need for Oxygen Support

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05781945

Enrollment

Registered

2023-03-23

Start date

2021-03-01

Completion date

2022-05-01

Last updated

2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Brief summary

The primary objective of our study was to evaluate the efficacy of a mix of three probiotic strains (Bifidobacterium lactis LA 304, Lactobacillus salivarius LA 302, and Lactobacillus acidophilus LA 201; Lactibiane Iki®) in the reduction in fecal calprotectin in patients with COVID-19 pneumonia, compared to a control group. The secondary aim was to evaluate the reduction in oxygen support and length of hospital stay in patients taking the probiotic mix.

Interventions

DIETARY_SUPPLEMENTprobiotics

supplementation with Bifidobacterium lactis LA 304, Lactobacillus salivarius LA 302,andLactobacillus acidophilus LA 201+ standard theraph for sars-cov-2

OTHERstandard therapy

standard therapy for sars-cov-2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients admitted to our hospital for SARS-CoV-2 infection with respiratory and/or gastrointestinal symptomsandradiological imaging (chest X-ray/CT with/without contrast) of interstitial pneumonia. Patients with mild COVID-19 disease (requiring oxygen support with 2L or 4L nasal cannula or Ventimask 28-35-40% to reach a SpO2-target of 95%)

Exclusion criteria

* patients on antibiotic therapy or patients who had taken antibiotics in the previous month; patients with IBD,IBS,or infectious colitis of non-COVID-19 bacterial and/or viral etiology; patients with colonic neoplasia (first to last stage); patients who had undergone colon surgery; patients with severe hepatopathy, nephropathy, heart disease or terminal oncological disease; pregnant women; and patients in circulatory shock and under positive pressure support on admission to hospital.

Design outcomes

Primary

Measure	Time frame	Description
efficacy of probiotics in reducing calprotectin and CRP	10 days	evaluate the efficacy of a mix of three probiotic strains (Bifidobacterium lactis LA 304, Lactobacillus salivarius LA 302,andLactobacillus acidophilus LA 201) in reducing fecal calprotectin and CRP in patients with COVID-19 pneumonia

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026