Effect of synbiotic on diabetes control

The effect of synbiotic on blood glucose level and HbA1c in children with type 1 diabetes. A parallel, double-blind, randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210712051866N1

Enrollment

Registered

2022-05-04

Start date

2022-05-22

Completion date

Unknown

Last updated

2022-05-30

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 with ketoacidosis

Interventions

Intervention 1: Intervention group: Synbiotic (Kidilact sachet of Zist-Takhmir company with the power of 10^9 CFU, containing Lactobacillus rhamnosus, Lactobacillus reuteri, Lactobacillus acidophilus,

Eligibility

Sex/Gender

All

Age

4 Years to 18 Years

Inclusion criteria

Inclusion criteria: Girls and Boys 4-18 Years At least 6 Months after the Diagnosis of Diabetes Being Treated with Injectable Insulin Fasting Blod Sugar (FBS) = 126 mg/dl Glocuse, 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

Exclusion criteria: Renal disease Gastrointestinal disease Cardiovascular disease (CVD) Pulmonary disease Taking antibiotics, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), immunosuppressants during the last month; Taking products containing probiotics and synbiotics or antioxidants in the last month

Design outcomes

Primary

Measure	Time frame
Blood glucose level. Timepoint: Blood glucose level measurement 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: BT-3000 chemistry analyzer.;Glycated hemoglobin (HbA1c). Timepoint: Glycated hemoglobin (HbA1c) measurement 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: BT-3000 chemistry analyzer.	—

Measure

Time frame

Blood glucose level. Timepoint: Blood glucose level measurement 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: BT-3000 chemistry analyzer.;Glycated hemoglobin (HbA1c). Timepoint: Glycated hemoglobin (HbA1c) measurement 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: BT-3000 chemistry analyzer.

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Secondary

Measure	Time frame
Hypoglycemia incidence. Timepoint: Determining the hypoglycemia incidence at any time of performing the intervention. Method of measurement: Glucometer.;Incidence of Diabetic Ketoacidosis (DKA). Timepoint: Determining the Incidence of Diabetic Ketoacidosis (DKA) at any time of performing the intervention. Method of measurement: Ketone bodies level and Arterial Blood Gas.;The need for injectable insulin. Timepoint: Determining the need for injectable insulin at any time of performing the intervention. Method of measurement: Based on the patient's blood sugar using a glucometer.	—

Measure

Time frame

Hypoglycemia incidence. Timepoint: Determining the hypoglycemia incidence at any time of performing the intervention. Method of measurement: Glucometer.;Incidence of Diabetic Ketoacidosis (DKA). Timepoint: Determining the Incidence of Diabetic Ketoacidosis (DKA) at any time of performing the intervention. Method of measurement: Ketone bodies level and Arterial Blood Gas.;The need for injectable insulin. Timepoint: Determining the need for injectable insulin at any time of performing the intervention. Method of measurement: Based on the patient's blood sugar using a glucometer.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfagh Hassanzadeh Rad

Rasht University of Medical Sciences

afaghrad@gums.ac.ir+98 13 3336 9019

Outcome results

None listed

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