Evaluation of the effect of probiotic supplementation Saccharomyces Boulardii(babyeast) compared to placebo on HA1c level in patients with type 1 diabetes
The use of Saccharomyces Boulardii (babyeast) probiotic in patients with type 1 diabetes to control glucose.
Design
This study is a randomized, placebo-controlled, double-blind, single-center clinical trial.
Settings and conduct
The current study was a double-blind randomized controlled clinical trial and was conducted on a population of 2 to 18 years old with type 1 diabetes who referred to Tehran Mofid hospital clinic in 1400. The samples were randomly divided into two groups receiving probiotics and placebo. Researchers and patients were blinded to the contents of the sachets.
Participants/Inclusion and exclusion criteria
The research community includes; The population of 2 to 18 years old with type 1 diabetes referred to Mofid hospital clinic in 1400 for routine care.
History of hospitalization for medical or psychiatric reasons and unwillingness to continue cooperation are taken into account in order to withdraw patients from the plan.
Intervention groups
Intervention group: Babyeast sachets contain 250 mg of lyophilized Saccharomyces boulardi yeast.90 days after the start of the study, the subjects will go to the clinic and the necessary drugs will be given for the next 90 days, and the same data will be collected again on the 180th day of the study.
Control group: Placebo is also made by Knowledge Enterprise biologyfermentation company similar to probiotic drug in Babyeast sachets containing 250 mg and provided to the researcher.
Main outcome variables
HbA1c; FBS; Average blood glucose 2 hours after a meal; the total amount of insulin received daily; triglycerides; HDL; Average FBS recorded by the patient; LDL and Cholesterol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230225057530N1
Registration date:2023-07-19, 1402/04/28
Registration timing:retrospective
Last update:2023-07-19, 1402/04/28
Update count:0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Maryam Sahraei ardakani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7021
Email address
m.sahraei67@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-03-19, 1401/12/28
Actual recruitment start date
2023-01-20, 1401/10/30
Actual recruitment end date
2023-03-19, 1401/12/28
Trial completion date
empty
Scientific title
Evaluation of the effect of probiotic supplementation Saccharomyces Boulardii(babyeast) compared to placebo on HA1c level in patients with type 1 diabetes
Public title
Evaluation of the effect of probiotics in patients with type 1 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 1 diabetes Diagnosed 18 months before entering the study
Refer to Mofid hospital clinic for routine care in 1400
Exclusion criteria:
Patients do not have a history of hospitalization for medical or psychiatric reasons in the last 12 months.
It is not possible to access by phone.
Age
From 2 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling has been done by census method and.Patients are randomly assigned to one of the two placebo and probiotic groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Babyeast sachets contain 250 mg of Saccharomyces boulardi lyophilized yeast.Placebo is also made by Knowledge enterprise biology fermentation company similar to probiotic drug and provided to the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave, Student Blvd, Valenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-05-02, 1402/02/12
Ethics committee reference number
IR.SBMU.MSP.REC.1402.026
2
Ethics committee
Name of ethics committee
Ethics committee of Endocrine and Metabolism Research Institute, Tehran University of Medical Scienc
Street address
Endocrinology and Metabolism Research Institute, next to Dr. Shariati Hospital, Jalal Al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713119
Approval date
2023-02-15, 1401/11/26
Ethics committee reference number
IR.TUMS.EMRI.REC.1401.158
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
Age Of The Patient
Timepoint
At The Beginning Of The Study
Method of measurement
Questionnaire-Clinical File
2
Description
Gender Of The Patient
Timepoint
At The Beginning Of The Study
Method of measurement
Questionnaire-Clinical File
3
Description
Patient Weight
Timepoint
At The Beginning Of The Study
Method of measurement
Scales
4
Description
Height Of The Patient
Timepoint
At The Beginning Of The Study
Method of measurement
Meter
5
Description
The Stage Of Maturation Of The Patient
Timepoint
At The Beginning Of The Study
Method of measurement
Questionnaire-Clinical File
6
Description
Patient Activity Level
Timepoint
At The Beginning Of The Study
Method of measurement
Questionnaire-Clinical File
7
Description
Duration Of Diagnosis Of Diabetes
Timepoint
At The Beginning Of The Study
Method of measurement
Questionnaire-Clinical File
8
Description
Type Of Insulin Used By The Patient
Timepoint
At The Beginning Of The Study
Method of measurement
Questionnaire-Clinical File
9
Description
The Total Amount Of Insulin Received Daily
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Questionnaire-Clinical File
10
Description
Fasting Blood Sugar
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Paraclinic - Laboratory
11
Description
Average Fasting Sugars
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Paraclinic - Laboratory
12
Description
Average Sugars 2 Hours After a Meal
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Paraclinic - Laboratory
13
Description
HbA1C
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Paraclinic - Laboratory
14
Description
HDL
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Paraclinic - Laboratory
15
Description
LDL
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Paraclinic - Laboratory
16
Description
Cholesterol
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Paraclinic - Laboratory
17
Description
Triglyceride
Timepoint
At the beginning of the study, day 90 and day 180 in patients
Method of measurement
Paraclinic - Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Babyeast sachets contain 250 mg of Saccharomyces boulardi lyophilized yeast. This product does not contain gluten or sweeteners. Each person is given 180 sachets for 6 months.90 days after the start of the study, the subjects went to the clinic, and at that time, the daily insulin consumption, the average fasting and 2-hour post-meal sugars, and HbA1c will be collected, and the drugs needed for the next 90 days will be given, and again on the 180th day of the study, the above data will be collected. is collected.
Category
Treatment - Drugs
2
Description
Control group: Placebo is also made by Knowledge Enterprise biologyfermentation company similar to probiotic drug in Babyeast sachets containing 250 mg and provided to the researcher