The Effect of Covid-19 on Breast Milk Microbiome and Its Bioactive Components

NCT04836754 | Unknown

• 1 other identifier: Covid-19
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19; Human Milk

Keywords

covid-19; human milk; microbiota; microbiome; bioactive ingredient

Outcome Measures

Primary Outcomes (2)

• data analysis:maternal and infant health

  Data Collection Form, Quality of Life Scale

  postpartum 15th day

• Microbiological Analysis:human milk

  16sRNA analysis

  postpartum 15th day

Study Arms (2)

Case group

Pregnant women with Covid-19

Control groups

Pregnant women who do not have Covid-19

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: mothers on the first day after birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The sample of the study: The population of the study will be 20 mothers who are hospitalized in the obstetrics clinic of the SBU Istanbul Sultangazi Haseki Training and Research Hospital for emergency delivery, who had Covid-19 during pregnancy (10 mothers) and healthy (10 mothers). Power analysis to determine the size, G-Power 3.1.9.2. program (Zuo et al., 2020). According to this calculation, a total of 20 mothers, a minimum of 10 mothers in each group, will be included in the sample, with a 95% confidence interval, alpha 0.05 and 80% power, with a 20% improvement difference between the two groups.

You may qualify if:

• 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

You may not qualify if:

• Expressing breast milk or having problems with the breast,
• The mother's use of probiotics before randomization and during pregnancy,

Sponsors & Collaborators

• Aysu Yıldız Karaahmet: lead
• Hacettepe University: collaborator

Study Sites (1)

Haseki Training and Research Hospital

Sultangazi, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Aysu Yıldız Karaahmet, Phd.Student

  Halic University

  PRINCIPAL INVESTIGATOR

• Gülümser Dolgun, Profesor

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Ceren Ozkul Kocak, Asist prof

  Hacettepe University

  STUDY DIRECTOR

Central Study Contacts

Aysu Y Yıldız Karaahmet, PhD Student

CONTACT

05414679620; aysuyildiz@halic.edu.tr

Gülümser Dolgun, Professor

CONTACT

05414679620; gdolgun@istanbul.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 8, 2021
• Study Start: May 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

TU (1)