Synbiotic Therapy of Gastrointestinal Symptoms During Covid-19 Infection
SynCov
1 other identifier
interventional
30
1 country
1
Brief Summary
We hypothesize that the intake of Omni-Biotic® 10 AAD can reduce intestinal inflammation and improves dysbiosis in Covid-19 disease. We further hypothesize that Omni-Biotic® 10 AAD can reduce the duration of diarrhea, stool frequency, improve stool consistency, improve other gastrointestinal symptoms of Covid-19, reduce disease duration and severity. The investigators aim to perform a randomized, double blind, placebo-controlled study using telemedicine in patients with Covid-19 disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
September 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMarch 4, 2025
March 1, 2025
1.2 years
June 4, 2020
March 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Stool calprotectin
measured by ELISA
30 days
Secondary Outcomes (8)
Stool frequency
30 days
Stool consistency
30 days
Gastrointestinal symptoms
30 days
Duration of Covid-19 disease
30 days
Severity of Covid-19 disease
30 days
- +3 more secondary outcomes
Study Arms (2)
Probiotic
ACTIVE COMPARATORGroup 1: receiving a probiotic mixture (Omni-Biotic® 10 AAD) twice a day
Placebo
PLACEBO COMPARATORGroup 2: receiving a similar looking and tasting placebo without bacteria twice a day
Interventions
Bacterial strains in Omni-Biotic® 10 AAD are Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Enterococcus faecium W54, Lactobacillus acidophilus W37, Lactobacillus acidophilus W55, Lactobacillus paracasei W20, Lactobacillus plantarum W1, Lactobacillus plantarum W62, Lactobacillus rhamnosus W71 and Lactobacillus salivarius W24 which are embedded in a matrix containing maize starch, maltodextrin, inulin, potassium chloride, hydrolysed rice protein, magnesium sulphate, fructooligosaccharide (FOS), enzymes (amylases), vanilla flavour and manganese sulphate
matrix containing maize starch, maltodextrin, inulin, potassium chloride, hydrolysed rice protein, magnesium sulphate, fructooligosaccharide (FOS), enzymes (amylases), vanilla flavour and manganese sulphate.
Eligibility Criteria
You may qualify if:
- years or older
- Covid-19 infection diagnosed by a positive SARS-Cov-2 PCR (Polymerase chain reaction) result from a nasopharyngeal swab
You may not qualify if:
- Technical difficulties to perform telemedicine study visits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal Medicine, Medical University of Graz
Graz, 8010, Austria
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2020
First Posted
June 9, 2020
Study Start
September 24, 2020
Primary Completion
December 1, 2021
Study Completion
December 31, 2024
Last Updated
March 4, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 1 year after completion
- Access Criteria
- free
Upload of microbiome sequences and metadata to a repository