Group 1: receiving a probiotic mixture (Omni-Biotic® 10 AAD) twice a day

Group 2: receiving a similar looking and tasting placebo without bacteria twice a day

COVID

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

Omnibiotic AAD

matrix containing maize starch, maltodextrin, inulin, potassium chloride, hydrolysed rice protein, magnesium sulphate, fructooligosaccharide (FOS), enzymes (amylases), vanilla flavour and manganese sulphate.

Placebo

Department of Internal Medicine, Medical University of Graz

Synbiotic Therapy of Gastrointestinal Symptoms During Covid-19 Infection

Synbiotic Therapy of Gastrointestinal Symptoms During Covid-19 Infection: A Randomized, Double-blind, Placebo Controlled, Telemedicine Study (SynCov Study)

Duration of diarrhea (defined as days with 3 or more loose stools)

Stool consistency according to Bristol stool scale for each evacuation, score 1-7, a higher score means a lower stool consistancy

presence of anorexia, nausea, vomiting, abdominal pain, bloating (yes/no)

days patients feel sick, are not able to work or are on sick leave

Upload of microbiome sequences and metadata to a repository

Medical University of Graz

1,200 pregnant women (600 HIV+ mothers and 600 HIV-controls) in their third trimester were enrolled from January 2016 to June 2019. Participants are being followed as mother-baby pairs at birth, within 10 days of life 6, 10, 14 24, 48, 72 and 96 weeks of age. At each visit clinical examinations are being used to assess health and the impact of environmental factors. In addition, questionnaires are administered and bio-samples for laboratory tests. The design of the study is non-interventional cohort but participants are being offered advice regarding health and hygiene.

maternal urine, stool, plasma, milk, cord blood, amniotic fluid, placenta, infant serum/plasma, dried blood spots and stool

HIV Infections

Immune Activation

Cormobidities

The University of Zimbabwe College of Health Science (UZ-CHS) BIRTH COHORT Study

HIV Exposure, Disease Acquisition and Progression Among Children: Role of Maternal Immunogenetics, Viral Genetic Diversity, HAART Exposure, Co-morbidities and Psycho-Social Status: (UZ-CHS Birth Cohort)

Comparison of morbidity of HEU vs. HUU infants, defined as impaired growth, immune- and neuro-development and/ or frequent clinically relevant infections

To determine any association of maternal HIV infection, HAART exposure.

To determine any association with maternal HIV and HAART exposure.

To determine any association of HAART exposure in utero and during breast feeding with pregnancy outcome, infant (HUU, HEU, HEI) growth and immune- and neuro-development.

To determine vertical transmission rates for HIV at birth and within the first 2 years of life and assess risk factors for transmission

HIV incidence rate among mother sero-negative at enrollment

To determine the association between maternal baseline and delivery HAART levels in different compartments and the relation of those to infant HIV transmission, mortality and morbidity.

To determine the association between antenatal immune dysregulation and infant death, growth and immune responses to vaccines.

To determine HIV drug resistance profiles in mother and infants unresponsive to HAART

To determine how CMV DNA is influenced by HIV infection, HAART use and as single infection or combined infections in HIV+ and HIV- women and determine the impact on pregnancy outcome and infant cmv vertical transmission

To determine how HBV infection infections in HIV+ and HIV- women and determine the impact on pregnancy outcome, infant vertical transmission

To determine HCV infections proportion in HIV positives and negatives and HIV+ and HIV- women and determine the impact on pregnancy outcome, infant incidence of congenital cmv infection

To determine syphilis infections proportion in HIV positives and negatives and the impact on pregnancy outcome, infant incidence of congenital syphilis infection

To determine the prevalence of helminthes infection using 18s sequencing and correlate with infant development of atopic dermatitis.

To determine the prevalence of maternal under and overnutrition using BMI and MUAC impact on pregnancy outcomes, infant mortality and morbidity.

To assess abnormalities in HIV + and HIV- including lipid profiles, bone, haematological (anemia) and hepatic toxicities associated with exposure to HAART among mothers and infants.

To determine infant non-infectious comorbidities (e.g. anaemia, atopic dermatitis, congenital infections and other conditions) and their impact on mortality and morbidity.

To assess delayed neuro-cognitive development using the Denver II tool in HUU, HEU and HEI infants and correlated with socio economic status and infectious diseases.

To determine humoural immune responses to EPI vaccines including antibody levels against measles, tetanus, diphtheria, pertussis, polio and rotavirus) in HUU, HEU and HEI infants.

To determine immune activation and systemic inflammatory biomarkers in HUU, HEU and HEI infants

To determine biomarkers for endothelial dysfunction including microbial translocation in HUU, HEU and HEI infants and association with household hygiene at delivery, 6, 48 and 96 weeks of age.

To determine antenatal reference ranges for MUAC, haemoglobin from FBC analyses, and biochemistry (kidney function, liver function tests, bone, lipid profiles) in mothers with a favourable outcome of pregnancy

To determine maternal- infant microbiota16S sequencing in pregnancy and relate it to infant immune development and atopy (anti-inflammatory (IL-4, -5, -13) and regulatory cytokines (IL-10, TGF-β) at delivery, 6 weeks 48 and 96 weeks of age.

Bacterial full genome metagenomics shotgun sequencing to identify the microbiota metabolic potential (i.e. bacterial genes present will be done) and mass spectrometry will be performed for analysis of small intestinal content (metabolome).

Wide range of nutritional profiles and HAART levels spectrometry will be performed for analysis of at least 700 metabolites including amino acids and lipids will be performed in plasma, breast milk and stool samples

To characterize pathogen genetic diversity including HIV, HBV, HCV, CMV subtypes, prevalent in our study population at time of infection

To determine host genetic markers for infectious disease susceptibility including human leukocyte antigen (HLA) and killer immunoglobulin like receptor (KIR) gene variants and their association with infection rates of HIV and co-infections in mothers and their infants.

Only anonymous data will be stored at local sites and transferred between sites for collaborative research efforts. All original data will be stored locally at the UZ-CHS for at least 10 years on suitable electronic devices. Data transfer with collaborating partners will be encrypted. using EGAcryptor. With our European partners we will follow the current European General Data Protection Regulation effective May 25, 2018.

Kerina Duri

Associate Professor

University of Zimbabwe

University Hospital Inselspital, Berne

University of Hamburg

University of Oxford

Wellcome Trust

University of Yaounde

University of Cape Town

Midlands State University, Zimbabwe

National Institute of Health Research, Zimbabwe

The study will include patients from the two main Italian liver transplantation centers (Ospedale Le Molinette, Torino and Azienda Ospedaliera Pisana, Pisa), allowing to enroll 220 patients in the first 18 months of the proposed study. More in details, all >18-years-old patients listed for and undergoing liver transplantation will be included in the study after signing an informed consent. Each patient will then be prospectively followed one year.

A second cohort of 55 patients will then be enrolled in the following 6 months as internal validation sample, and will be analogously monitored until the end of the 3-years-long study.

Orthotopic Liver Transplantation

IRCCS San Raffaele

Azienda Ospedaliero, Universitaria Pisana

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Enteric Microbiome and Liver Transplantation

Identification of Enteric Microbiome Markers in the Early Prediction of Liver Transplantation Adverse Outcomes.

7-8% estimated overall incidence at one year post-LT

Nicasio Mancini

Associate Professor of Medical Microbiology and Virology

participants receive a daily dose of OMNI-BiOTiC PPI for three months

Patients on Long-term Proton Pump Inhibitor Therapy

The study product consists of a sachet containing 4g of yellowish powder made of corn starch, maltodextrin, fructo-oligosaccharide P6, inulin P2, vegetable protein and 12 bacterial strains (Bacillus coagulans W183, Bacillus subtilus W201, Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus acidophilus W22, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19, Propionibacterium freudenreichii W200, Lactobacillus rhamnosus W71, in a concentration of 2 x 109 cfu/g).

OMNI-BiOTiC PPI

Probiotic Modulation of Intestinal Microbiota in Long-term Intake of Proton Pump Inhibitors

Probiotic Modulation of Intestinal Microbiota in Long-term Intake of Proton Pump Inhibitors: Influence on Intestinal Inflammation and Digestion

Calprotectin levels are measured in ng/mg stool using enzyme linked immunosorbent assay (ELISA) at baseline, after 3 months of intervention and after further 3 months of follow up

relative abundance of bacteria in the gut microbiome will be assessed using 16S DNA sequencing, bacteria from the oral cavity will be especially investigated at baseline, after 3 months of intervention and after further 3 months of follow up

Zonulin levels are measured in ng/mg stool using enzyme linked immunosorbent assay (ELISA) at baseline, after 3 months of intervention and after further 3 months of follow up

endotoxin levels are measured in endotoxin units/ml serum using a cell based detection method at baseline, after 3 months of intervention and after further 3 months of follow up

LBP levels are measured in µg/ml serum using ELISA at baseline, after 3 months of intervention and after further 3 months of follow up

sCD14 levels are measured in µg/ml serum using ELISA at baseline, after 3 months of intervention and after further 3 months of follow up

VitB12 levels are measured as part of the routine laboratory report at baseline, after 3 months of intervention and after further 3 months of follow up

Quality of life will be described using the Short Form 36 Questionnaire at baseline, after 3 months of intervention and after further 3 months of follow up

gastrointestinal quality of life will be described using the GIQLI questionnaire according to Eyparsch at baseline, after 3 months of intervention and after further 3 months of follow up

Changes in nutritional behaviour due to the intervention will be determined by a food frequency questionnaire at baseline, after 3 months of intervention and after further 3 months of follow up

dysbiosis/potasyòm

Synbiotic Therapy of Gastrointestinal Symptoms During Covid-19 Infection

The University of Zimbabwe College of Health Science (UZ-CHS) BIRTH COHORT Study

Enteric Microbiome and Liver Transplantation

Probiotic Modulation of Intestinal Microbiota in Long-term Intake of Proton Pump Inhibitors

Baz done ki pi konplè remèd fèy medsin te apiye nan syans