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Studying the effect of probiotic Lactobacillus reuteri on blood sugar control in children with type 1 diabetes: A randomized, double-blind clinical trial study

Studying the effect of probiotic Lactobacillus reuteri on blood sugar control in children with type 1 diabetes: A randomized, double-blind clinical trial study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250217064748N1
Enrollment
50
Registered
2025-06-24
Start date
2025-07-24
Completion date
Unknown
Last updated
2025-07-21

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:Participants in this group will receive sachets of sub-oral probiotic Lactobacillus reuteri for 16 weeks. Dosage and Administration:Th

Sponsors

Yasouj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: Type 1 diabetes Age 1 to 18 years Child receiving continuous subcutaneous insulin infusion (SC) Informed consent to participate in the study No underlying disease other than diabetes Same three-month blood sugar (HbA1c)

Exclusion criteria

Exclusion criteria: Severe gastrointestinal, hepatic, renal, cardiovascular, autoimmune, psychiatric or infectious diseases, acute complications of diabetes in the past Gastrointestinal or abdominal surgery within the past year Medications affecting insulin sensitivity (such as immunosuppressants, steroids) Sensitivity to probiotics Prescription of other probiotics or probiotic products in the past Non-adherence to treatment or any unwanted drug side effects following probiotic consumption.

Design outcomes

Primary

MeasureTime frame
Fasting blood sugar and 2 hours after a meal. Timepoint: At the beginning of the study and 1 week after the start of the study and fasting blood sugar measurement on the first day of each month. Method of measurement: Blood test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh safari jadval ghadam

Yasouj University of Medical Sciences

Fatemesafai73@gmail.com+98 74 3322 3412

Outcome results

None listed

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