Effect of synbiotic in treatment of diabetes

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220313054269N1

Enrollment

Registered

2022-05-24

Start date

2022-05-28

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 without complications

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 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

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

Design outcomes

Primary

Measure	Time frame
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.;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.;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.;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.	—

Measure

Time frame

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.;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.;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.;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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSara Sarrafizadeh

Islamic Azad University, Science and Research Branch

sara.sarrafi@gmail.com+98 21 4486 7161

Outcome results

None listed

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