COVID-19 Pneumonia and Gut Inflammation | NCT05781945

Studies
COVID-19 Pneumonia and Gut Inflammation

NCT05781945

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Completed

Last Update Posted

Mar 23, 2023Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Inflammation

Interventions

probiotics
standard therapy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Jan 31, 2022Actual

Completion Date

May 1, 2022Actual

First Submitted Date

Mar 21, 2023

First Submission Date that Met QC Criteria

Mar 22, 2023

First Posted Date

Mar 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2023

Last Update Posted Date

Mar 23, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

OJETTI VERONICA, Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
probiotic +	Experimental		Dietary Supplement: probiotics
standard therapy	Active Comparator		Other: standard therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
probiotics	Dietary Supplement	supplementation with Bifidobacterium lactis LA 304, Lactobacillus salivarius LA 302,andLactobacillus acidophilus LA 201+ standard theraph for sars-cov-2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	10 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario A. Gemelli IRCCS		Roma		00168	Italy

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics
D059039	Standard of Care

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided