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The effect of combination therapy with insulin and synbiotic on platelet indices in children with type 1 diabetes

Protocol summary

Study aim
To determine the effect of combination therapy with insulin and synbiotic on platelet indices in children with type 1 diabetes
Design
Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 76 patients. SAS software version 9 will be used for randomization.
Settings and conduct
In this randomized, double-blind, clinical trial (blinding for participants and the researcher) we investigate the effect of KidiLact supplement (produced by Zist-Takhmir Company - Iran) on platelet indices in 4-18 years-old children with type 1 diabetes referring to endocrinology clinic of 17 Shahrivar Hospital in Rasht. In this study, for 12 weeks, in addition to the main treatment (injectable insulin), the intervention group is given 1 sachet of synbiotic and the control group is given 1 sachet of placebo, daily. At the beginning and the end of the intervention, 5cc blood samples are taken from the participants to evaluate and compare biochemical factors.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 4-18 years; Being treated with injectable insulin; Having type 1 diabetes Non-inclusion criteria: Taking antibiotics, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), immunosuppressants during the last month; Taking products containing probiotics and synbiotics in the last month; Metabolic disease; Gastrointestinal disease; Cardiovascular disease (CVD); Renal disease
Intervention groups
Daily, the intervention group takes 1 sachet of KidiLact supplement (product of Zist-Takhmir Company - Iran) for 12 weeks. The control group also takes 1 sachet of placebo (product of Zist-Takhmir Company - Iran) daily for 12 weeks.
Main outcome variables
Blood Platelet Count (PLT); Platelet Percentage (PCT); Mean Platelet Volume (MPV); Platelet Distribution Width (PDW)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220313054269N1
Registration date: 2022-05-24, 1401/03/03
Registration timing: prospective

Last update: 2022-05-24, 1401/03/03
Update count: 0
Registration date
2022-05-24, 1401/03/03
Registrant information
Name
Seyed Jafar Aldaghi
Name of organization / entity
Science and Research Branch of Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 938 561 1676
Email address
j.aldaghi74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-28, 1401/03/07
Expected recruitment end date
2022-08-19, 1401/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combination therapy with insulin and synbiotic on platelet indices in children with type 1 diabetes
Public title
Effect of synbiotic in treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Girls and Boys 4-18 Years Being Treated with Injectable Insulin Fasting Blood Sugar (FBS) ≥ 126 mg/dl Glucose, 2 hour Post Prandial (2hpp) ≥ 200 mg/dl Glycated Hemoglobin (HbA1c) ≥ 6.5% Blood Sugar (BS) ≥ 200 mg/dl Along with Polydipsia and Polyuria
Exclusion criteria:
Taking antibiotics, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), immunosuppressants during the last month Taking products containing probiotics and synbiotics in the last month Metabolic disease Gastrointestinal disease Cardiovascular disease (CVD) Renal disease
Age
From 4 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the treatment between two groups, Permuted Block Randomization Method with the Size 4, will be used. Considering the time of patients entry into the study and that A is (Intervention group) and B is (Control group), A Part of the Random Allocation will be as follows: Randomization is done with SAS software version 9. Seed: 253569775886591 Block sizes: 4 Actual list length: 76 block identifier, block size, sequence within block, treatment • 1, 4, 1, Group B • 1, 4, 2, Group A • 1, 4, 3, Group B • 1, 4, 4, Group A • 2, 4, 1, Group B • 2, 4, 2, Group A • 2, 4, 3, Group B • 2, 4, 4, Group A Groups assignment will be performed by the closed envelopes. The researcher registers the participants and the statistician determines the allocation sequence using the relevant softwares.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind, randomized, clinical trial, blinding will be performed for the researcher (outcome assessor) and the participants. The researcher (outcome assessor) doesn't know which participant is in the intervention or control group and the participants don't know which group they are in.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University, Science and Research Branch
Street address
Science and Research Branch, Daneshgah Square, Simon Bulivar Blvd, Ashrafi Esfahani Expy
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2021-11-02, 1400/08/11
Ethics committee reference number
IR.IAU.SRB.REC.1400.175

Health conditions studied

1

Description of health condition studied
Type 1 diabetes
ICD-10 code
E10.9
ICD-10 code description
Type 1 diabetes mellitus without complications

Primary outcomes

1

Description
Blood Platelet Count (PLT)
Timepoint
Blood Platelet counting at the beginning of the intervention (Before the start of the intervention) and 12 weeks after the start of synbiotic and/or placebo usage
Method of measurement
Sysmex XS800 hematology analyzer

2

Description
Platelet Percentage (PCT)
Timepoint
Platelet Percentage calculating at the beginning of the intervention (Before the start of the intervention) and 12 weeks after the start of synbiotic and/or placebo usage
Method of measurement
Sysmex XS800 hematology analyzer

3

Description
Mean Platelet Volume (MPV)
Timepoint
Mean Platelet Volume calculating at the beginning of the intervention (Before the start of the intervention) and 12 weeks after the start of synbiotic and/or placebo usage
Method of measurement
Sysmex XS800 hematology analyzer

4

Description
Platelet Distribution Width (PDW)
Timepoint
Platelet Distribution Width calculating at the beginning of the intervention (Before the start of the intervention) and 12 weeks after the start of synbiotic and/or placebo usage
Method of measurement
Sysmex XS800 hematology analyzer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Synbiotic (Kidilact sachet of Zist-Takhmir company with the power of 10^9 CFU, containing Lactobacillus rhamnosus, Lactobacillus reuteri, Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus casei, Bifidobacterium infantis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium lactis, Sterptococcus thermophilus Suchets and Fructooligosaccharide) is given to the intervention's group participants in the same 1 gram powder form sachets. Everyday, participants mix one sachet weighing 1 gram with 250ml water and drink it 15-20 mins before the evening meal.
Category
Treatment - Drugs

2

Description
Control group: Placebo (Product of Zist-Takhmir company, Containing Lactose monohydrate 80 Mesh, Inulin, Talc, Magnesium stearate, Colloidal silicon dioxide, Sucralose, Corn flour and Xanthan gum) is given to the intervention's group participants in the same 1 gram powder form sachets. Everyday, participants mix one sachet weighing 1 gram with 250ml water and drink it 15-20 mins before the evening meal.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinology Clinic of 17 Shahrivar Hospital
Full name of responsible person
Setila Dalili
Street address
17 Shahrivar Educational, Therapeutic and Research Center, South of the City Park, Siadati Ave, Namjou Blvd
City
Rasht
Province
Guilan
Postal code
4144654379
Phone
+98 13 3336 9019
Email
setiladalili1346@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Science and Research Branch
Full name of responsible person
Babak Mozafari
Street address
Science and Research Branch, Daneshgah Square, Simon Bulivar Blvd, Ashrafi Esfahani Expy
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5239
Email
research@srbiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice-Chancellor for Research & Technology, Islamic Azad University, Science and Research Branch
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
Islamic Azad University, Science and Research Branch
Full name of responsible person
Sara Sarrafizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Science and Research Branch, Daneshgah Square, Simon Bulivar Blvd, Ashrafi Esfahani Expy
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 7161
Email
sara.sarrafi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Setila Dalili
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
17 Shahrivar Educational, Therapeutic and Research Center, South of the City Park, Siadati Ave, Namjou Blvd
City
Rasht
Province
Guilan
Postal code
4144654379
Phone
+98 13 3336 9019
Email
setiladalili1346@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Science and Research Branch
Full name of responsible person
Seyed Jafar Aldaghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Science and Research Branch, Daneshgah Square, Simon Bulivar Blvd, Ashrafi Esfahani Expy
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 938 561 1676
Email
j.aldaghi74@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of patients information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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