COVID Clinical Trial
— SynCovOfficial title:
Synbiotic Therapy of Gastrointestinal Symptoms During Covid-19 Infection: A Randomized, Double-blind, Placebo Controlled, Telemedicine Study (SynCov Study)
Verified date | March 2024 |
Source | Medical University of Graz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | December 2024 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria - 18 years or older - Covid-19 infection diagnosed by a positive SARS-Cov-2 PCR (Polymerase chain reaction) result from a nasopharyngeal swab - Informed (tele)consent Exclusion criteria - Pre-existing diarrhoea (including but not restricted to chronic inflammatory bowel disease, chronic diarrhea of other causes, acute diarrheal illness -4 to -1 week before inclusion) - Antibiotic therapy -4 to -1 week before inclusion - Probiotic treatment -4 to -1 week before inclusion - Technical difficulties to perform telemedicine study visits |
Country | Name | City | State |
---|---|---|---|
Austria | Department of Internal Medicine, Medical University of Graz | Graz |
Lead Sponsor | Collaborator |
---|---|
Medical University of Graz |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stool calprotectin | measured by ELISA | 30 days | |
Secondary | Stool frequency | stool evacuations per days | 30 days | |
Secondary | Stool consistency | Stool consistency according to Bristol stool scale for each evacuation, score 1-7, a higher score means a lower stool consistancy | 30 days | |
Secondary | Gastrointestinal symptoms | presence of anorexia, nausea, vomiting, abdominal pain, bloating (yes/no) | 30 days | |
Secondary | Duration of Covid-19 disease | days patients feel sick, are not able to work or are on sick leave | 30 days | |
Secondary | Severity of Covid-19 disease | mild/moderate/severe | 30 days | |
Secondary | Diarrhea | 3 or more stool evacuations, consistency Bristol stool scale 5-7 | 30 days | |
Secondary | Stool Zonulin | measured by ELISA | 30 days | |
Secondary | Microbiome composition | 16S RNA sequencing | 30 days |
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