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Evaluation of the complementary effect of synbiotic adjuvant on inflammatory markers and clinical manifestations in patients with COVID-19

Protocol summary

Study aim
Evaluation of the effect of synbiotic supplementation on inflammatory markers (CRP, ESR, IL-6, CBC) and clinical manifestations before and 8 weeks after treatment in patients with COVID-19
Design
Clinical trial with parallel control group, double-blind, randomized, phase 0 on 80 patients. Stratified block randomization method was used for randomization.
Settings and conduct
In this interventional study, patients with COVID-19 are studied; which are randomly divided into case and control groups. These patients receive probiotic or placebo treatment for two months. All patients are blinded to the type of intervention. They do not know about receiving medication or placebo.
Participants/Inclusion and exclusion criteria
People between the ages of 18-70; basic literacy; writing ability and memory strength; mental conditions to continue attending the study and completing the consent form are studied. People who participate in other clinical trial studies at the same time, other acute and serious illnesses; regular and periodic use of certain dietary supplements or special diets; taking other probiotic supplements; receiving full dose corticosteroids; people with pancreatitis, sepsis, dialysis, central vein and chronic diarrhea; people waiting for abdominal surgery; people with acute immune deficiencies such as AIDS; people with short bowel syndrome or at risk for mesenteric ischemia and pregnant women or breastfeeding mothers are excluded from the study.
Intervention groups
Case group: In this group, patients take two synbiotic adjuvant capsules (after lunch) every day for 2 months of intervention. Control group: In this group, patients take two placebo capsules every day (after lunch) for 2 months of intervention.
Main outcome variables
Clinical symptoms; Inflammatory markers (IL-6, CRP, ESR, CBC, ...)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200923048815N1
Registration date: 2020-10-15, 1399/07/24
Registration timing: prospective

Last update: 2020-10-15, 1399/07/24
Update count: 0
Registration date
2020-10-15, 1399/07/24
Registrant information
Name
Majid Aghadavood Marnani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
majid.aghadavood@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the complementary effect of synbiotic adjuvant on inflammatory markers and clinical manifestations in patients with COVID-19
Public title
The effect of synbiotic on inflammatory markers and clinical manifestations in patients with C0VID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-70 years old Basic literacy Writing ability and healthy memory Mental conditions for continuing to attend the study and completing the consent form
Exclusion criteria:
Simultaneous participation in other clinical trial studies Having other acute and serious diseases Regular and periodic consumption of special dietary supplements or special diets Taking other probiotic supplements Receive corticosteroids in full dose People with pancreatitis, sepsis, dialysis, central venous and chronic diarrhea People waiting for abdominal surgery People with acute immune deficiencies such as AIDS People with short bowel syndrome or are at risk for mesenteric ischemia Pregnant women and mothers who are breastfeeding.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
A randomization method will be used to allocate participants to the groups with a 1:1 allocation using random allocation software (RAS). Similar sealed envelopes will be used to conceal the allocation in a sequentially numbered package.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants, patient's clinical caregiver, outcome assessor, and data analyst were unaware of drug or placebo use.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Soffeh Blvd, Alzahra Hospital
City
Esfahan
Province
Isfehan
Postal code
8174675731
Approval date
2020-05-30, 1399/03/10
Ethics committee reference number
IR.MUI.MED.REC.1399.204

Health conditions studied

1

Description of health condition studied
Coronavirus infection
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
inflammatory markers
Timepoint
Before and 8 weeks after start of intervention
Method of measurement
Biochemical analysis

Secondary outcomes

1

Description
Clinical symptoms
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Comment by physician

Intervention groups

1

Description
Intervention group: Patients in this group use Lactocar brand Synbiotic in the form of 250 capsules containing 7 probiotic strains. Two capsules are consumed every day after lunch for 8 weeks.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group use placebo for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Majid Aghadavood Marnani
Street address
Soffeh Blvd
City
Esfahan
Province
Isfehan
Postal code
‎8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoy Javanmard
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services, Building No. 4, Vice Chancellor for Research and Technology
City
Esfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Majid Aghadavood Marnani
Position
Gastroentrology Fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Soffeh Blvd, Alzahra Hospital
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Majid.aghadavood@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masha Khodadoostan Shahraki
Position
Gastroentrologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Soffeh Blvd, Alzahra Hospital
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
mkhodadoostan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Majid Aghadavood Marnani
Position
Gastroentrology Fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Soffeh Blvd, Alzahra Hospital
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Majid.aghadavood@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome is shared.
When the data will become available and for how long
The start of the information access period is after the results are published.
To whom data/document is available
Researchers working in academic institutions and artisans can access information.
Under which criteria data/document could be used
The use of information in scientific articles is unrestricted.
From where data/document is obtainable
After the article is published, the information is available through reputable scientific sites.
What processes are involved for a request to access data/document
After the article is published, the information is available through reputable scientific sites.
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