Back to resultsCOVID-19 Pneumonia and Gut Inflammation
Primary Purpose
Inflammation
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
probiotics
standard therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Inflammation
Eligibility Criteria
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.
Sites / Locations
- Fondazione Policlinico Universitario A. Gemelli IRCCS
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
probiotic +
standard therapy
Arm Description
Outcomes
Primary Outcome Measures
efficacy of probiotics in reducing calprotectin and CRP
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05781945
First Posted
March 21, 2023
Last Updated
March 22, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05781945
Brief Title
COVID-19 Pneumonia and Gut Inflammation
Official Title
COVID-19 Pneumonia and Gut Inflammation: The Role of a Mix of Three Probiotic Strains in Reducing Inflammatory Markers and Need for Oxygen Support
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
probiotic +
Arm Type
Experimental
Arm Title
standard therapy
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics
Intervention Description
supplementation with Bifidobacterium lactis LA 304, Lactobacillus salivarius LA 302,andLactobacillus acidophilus LA 201+ standard theraph for sars-cov-2
Intervention Type
Other
Intervention Name(s)
standard therapy
Intervention Description
standard therapy for sars-cov-2
Primary Outcome Measure Information:
Title
efficacy of probiotics in reducing calprotectin and CRP
Description
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
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
COVID-19 Pneumonia and Gut Inflammation
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