Covid19 Clinical Trial
Official title:
The Effect of Covid-19 on Breast Milk Microbiome and Its Bioactive Components
Coronavirus disease (Covid-19) is a new public health crisis threatening humanity caused by SARS-CoV-2. Although it originated in China's Hubei province in late 2019, it has spread to many countries around the world. Although Covid-19 first caused infection by affecting the lung, current data showed that the gastrointestinal tract was also affected by detecting viral RNA in Covid-19-infected human intestinal epithelial cells and feces. The association has been confirmed by showing that patients hospitalized with COVID-19 have significant changes in intestinal bacterioma. These changes have been characterized by a significant reduction in gut microbiome (BM) diversity associated with gastrointestinal complaints of the acute phase of infection (e.g. abdominal pain, nausea, vomiting, diarrhea), depletion of beneficial bacterial symbionts, and enrichment of opportunistic pathogens (e.g. Streptococcus, Rothia, Actinomyces). In particular, recent studies have evidence that patients with Covid-19 are more prone to a dysbiosis profile of the gut microbiota, infected individuals present irregular gut microbiota, and even dysbiosis (disruption of microbiota balance) in the gut microbiota. The first case reports reported in China suggested that there was no virus found in amniotic fluid, umbilical cord blood, throat swabs of the newborn, placenta, vaginal fluid, and breast milk samples infected with Covid-19. The latest data indicate that there is no vertical transmission to the fetus, and so far, no viruses have been found in the cord blood of newborns born from Covid-19 positive pregnant women, nasal sampling and amniotic fluid and placentas of pregnant women. However, the effect of intestinal microbial structure affected by Covid-19 on breast milk microbiota and the effect of a dysbiosis to occur on infant health or the effect of the healing properties of breast milk on Covid-19 are still not clearly known. This views are that intestinal microbial colonization originating from the gastrointestinal system affected by Covid-19 will affect breast milk microbial colonization. However, there is no study on this subject. For this purpose, aim in this study was to determine the breast milk microbiome and biologically active proteins (secretory immunoglobulin A (sIgA), lysozyme, lactoferrin, osteoprotegerin (OPG), leptin, adiponectin and β-endorphin (b-) levels of mothers who had Covid-19 with healthy mothers. will be compared.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | September 1, 2022 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - The cognitive level of the mother is sufficient to understand and answer the questions, - Having a single pregnancy, - Mother's ability to read, write and understand Turkish - The time of delivery is in the range of 37 <GH <42 weeks - Not having a chronic disease of the mother (Diabetes, hypertension, hypothyroidism etc.) Vaginal delivery - The mother's not using antibiotic derivative drugs during pregnancy - Getting 10 points below the Beck Depression Scale - Absence of prematurity, Introuterine Growth Retardation (IUGR) or genetic disease in the newborn - Birth weight in the range of 2500-4000 gr - Absence of a gastrointestinal disease in the newborn - Feeding more than 50% of the baby with breast milk - Absence of Premature Membrane Rupture (PROM) for more than 24 hours at birth Exclusion Criteria: - Expressing breast milk or having problems with the breast, - The mother's use of probiotics before randomization and during pregnancy, - The inclusion of sampled mothers in other clinical studies at the same time. |
Country | Name | City | State |
---|---|---|---|
Turkey | Haseki Training and Research Hospital | Sultangazi | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Aysu Yildiz Karaahmet | Hacettepe University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | data analysis:maternal and infant health | Data Collection Form, Quality of Life Scale | postpartum 15th day | |
Primary | Microbiological Analysis:human milk | 16sRNA analysis | postpartum 15th day |
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