Last Verified: | May/31/2020 |
First Submitted: | June/3/2020 |
Estimated Enrollment Submitted: | June/4/2020 |
First Posted: | June/8/2020 |
Last Update Submitted: | June/4/2020 |
Last Update Posted: | June/8/2020 |
Actual Study Start Date: | July/31/2020 |
Estimated Primary Completion Date: | November/30/2021 |
Estimated Study Completion Date: | November/30/2022 |
Study Type: | Interventional |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Arm | Intervention/treatment |
---|---|
Active Comparator: Probiotic Group 1: receiving a probiotic mixture (Omni-Biotic® 10 AAD) twice a day | Dietary Supplement: Probiotic 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 |
Placebo Comparator: Placebo Group 2: receiving a similar looking and tasting placebo without bacteria twice a day | Dietary Supplement: Placebo matrix containing maize starch, maltodextrin, inulin, potassium chloride, hydrolysed rice protein, magnesium sulphate, fructooligosaccharide (FOS), enzymes (amylases), vanilla flavour and manganese sulphate. |
Ages Eligible for Study: | 18 Years to 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria: | 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 - Sudden onset of diarrhea (two or more loose stools, i.e. Bristol 5-7) - 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 |