Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study
입원하지 않은 경증에서 중등도의 COVID-19 환자에서 장내 미생물군유전체 조절의 자연사 및 영향을 평가하기 위한 가상화된 임상 연구 장내 미생물군 구조에 대한 KB109의 생리학적 효과를 평가하는 병렬 그룹 연구와 함께 무작위, 공개, 전향적 연구 및 기능: 무작위 대조 연구를 위한 연구 프로토콜의 구조화된 요약
Letter
[키워드] 1:1
24 hours
Ability
absence
addition
adhere
Affect
age
Ageusia
allergy
analysed
Anosmia
Anosmia/ageusia
Antacid
Antibiotics
Antiviral
assessment
assigned
Autoimmune disease
Bariatric surgery
baseline
bilevel positive airway pressure
Biomarker
Biomarkers
biomarkers of inflammation
BiPAP
Blinding
blocker
Blood
blood sample
Blood samples
both groups
bowel
bowel resection
breath
Care
care provider
Cell
change
Chest
chest tightness
chills
chronic lung disease
cirrhosis
clinical
clinical study
clinical trial
Cold
collected
Community
Comorbidity
comparator Patients
completion
Compliance
component
computer
Concomitant medication
concomitant medications
concurrent
condition
conducted
contraindications
coronavirus disease
Coronavirus disease 2019
cough
COVID-19
COVID-19 in patient
COVID-19 symptom
COVID-19 symptoms
COVID-19 testing
COVID-19-related symptom
COVID-19-related symptoms
COVID-19–related symptom
COVID-19–related symptoms
CPAP
Cytokines
D-dimer
daily dose
Day
defined
diarrhea
dissemination
drug
duration of symptom
Effect
element
eligible
Enrollment
evaluate
evaluate the effect
evaluated
exacerbated
exclusion criteria
exploratory
fatigue
fatty
Fatty acid
feasible
Female patients
Fever
fiber
Follow-up
follow-up period
following
group
Gut
gut microbiome
gut microbiome composition
gut microbiota
headache
Health
Health care
Health Care Utilization
Health status
healthcare
Histamine
history
hospital
Hospital admission
Hospital admissions
Hospitalization
Hospitalized
hypoxia
Identifier
IgM/IgG
Immunity
immunomodulatory
immunosuppressive
immunosuppressive therapy
in both group
include
Infection
Inflammation
Inflammatory biomarker
Inflammatory bowel disease
information
Informed consent
inhibitors
intake
Interaction
investigational agent
irritable bowel syndrome
KB109
Laboratory
laboratory measures
lactating
library
life
Liver disease
Lung disease
magnitude
malignancy
management
measure
Measures
medication
medications
Medicine
metabolite
Microbiome
microbiota
Mild
mild to moderate
Mild to moderate COVID-19
mild to moderate disease
moderate
Moderate COVID-19
moderate disease
modulate
modulation
muscle pain
nasal congestion
neutralization assays
not limited
nucleic acid
number
objective
Open-label
opinion
other compound
other compounds
outcome
outcome measure
Outpatient
outpatients
oxygen
oxygen saturation
Oxygen therapy
Pain
parallel group
participant
Participation
Patient
patient population
Period
Physical examination
positive airway pressure
Positive test
Potential
pre-symptomatic
pregnant
Primary outcome
progression
proportion
proportions
Prospective Study
PROTECT
protocol
protocols
proton pump
provided
pulse
Pulse oximeter
Quality of life
Quantitative
question
randomisation
randomised
randomised controlled study
randomization
Randomized
randomized controlled study
receive
recruitment
reduction
Registered
reported
response
resting position
risk
risk of infection
Sample size
screened
selected
self-care
sensitivities
Sequencing
serological
serology
shaking
short-chain fatty acids
Shortness of breath
Sleep
sleep apnea
Smartphone
sore throat
specific biomarker
specific biomarkers
Spread
SSC
Standard
Stool
stratified
Study design
Study protocol
study visit
supplementary material
Swab
Symptom
symptomatic patient
Symptomatic patients
Symptoms
syndrome
Tablet
TEAEs
Telemedicine
telephone
temperature
the patient
The United States
therapy
time
Tolerability
Treatment
treatment-emergent adverse event
undergo
United States
unlikely
Viral
Viral load
water
website
worsening
[DOI] 10.1186/s13063-021-05157-0 PMC 바로가기 [Article Type] Letter
[DOI] 10.1186/s13063-021-05157-0 PMC 바로가기 [Article Type] Letter