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Assessment of the effects of probiotic in children with diabetes

The effects of oral probiotic on glycosylated hemoglobin levels in children with type 1 diabetes mellitus

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180128038534N1
Enrollment
52
Registered
2018-06-13
Start date
2018-05-01
Completion date
Unknown
Last updated
2018-07-16

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

Conditions

Diabetes mellitus type 1. Type 1 diabetes mellitus without complications

Interventions

Intervention 1: Intervention group: The probiotic substance is given to this group. The chemical composition of this drug in each capsule is non-pathogenic bacteria of Lactobacillus acidophilus specie

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 16 Years

Inclusion criteria

Inclusion criteria: Diagnosis of Type 1 diabetes mellitus is proven. Children aged between 16 and 2 years old. The onset of the disease should be at last 3 years. The patient has no proven immune deficiency.

Exclusion criteria

Exclusion criteria: Probiotic has received within last 4 weeks. There are gastrointestinal infections in the last 2 weeks. The child has chronic bowel disease.

Design outcomes

Primary

MeasureTime frame
Glycosylated hemoglobin level. Timepoint: Measurement of hemoglobin glycosylated levels at the beginning of the study (before the intervention) and a week after the end of the intervention. Method of measurement: Enzymatic method.

Secondary

MeasureTime frame
Fasting blood sugar level. Timepoint: Measurement of fasting blood sugar levels at the beginning of the study (before the intervention) and a week after the end of the intervention. Method of measurement: Enzymatic method.;Serum lipids level. Timepoint: Measurement of serum lipids level at the beginning of the study (before the intervention) and a week after the end of the intervention. Method of measurement: Enzymatic method.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHosein Shabani Mirzaee

Tehran University of Medical Sciences

h-shabani@sina.tums.ac.ir+98 21 7301 3000

Outcome results

None listed

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