Evaluation of the effect of probiotics in patients with type 1 diabetes

Evaluation of the effect of probiotic supplementation Saccharomyces Boulardii(babyeast) compared to placebo on HA1c level in patients with type 1 diabetes

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230225057530N1

Enrollment

Registered

2023-07-19

Start date

2023-01-20

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes. Type 1 diabetes mellitus without complications

Interventions

Intervention 1: 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 fo

Eligibility

Sex/Gender

All

Age

2 Years to 18 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Age Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File.;Gender Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File.;Patient Weight. Timepoint: At The Beginning Of The Study. Method of measurement: Scales.;Height Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Meter.;The Stage Of Maturation Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File.;Patient Activity Level. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File.;Duration Of Diagnosis Of Diabetes. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File.;Type Of Insulin Used By The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File.;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.;Fasting Blood Sugar. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory.;Average Fasting Sugars. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory.;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.;HbA1C. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory.;HDL. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory.;LDL. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory.;Cholesterol. Timepoint: At the beginning of the study, day 90 and day 18	—

Measure

Time frame

Age Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File.;Gender Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File.;Patient Weight. Timepoint: At The Beginning Of The Study. Method of measurement: Scales.;Height Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Meter.;The Stage Of Maturation Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File.;Patient Activity Level. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File.;Duration Of Diagnosis Of Diabetes. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File.;Type Of Insulin Used By The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File.;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.;Fasting Blood Sugar. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory.;Average Fasting Sugars. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory.;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.;HbA1C. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory.;HDL. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory.;LDL. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic - Laboratory.;Cholesterol. Timepoint: At the beginning of the study, day 90 and day 18

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Sahraei ardakani

Shahid Beheshti University of Medical Sciences

m.sahraei67@yahoo.com+98 21 2222 7021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026