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oral Probiotic in Diabetes mellitus -type 1

Investigation of efficacy of oral Probiotic in glycemic control and duration of honeymoon period in children affected by Diabetes mellitus -type 1

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200117046164N3
Enrollment
130
Registered
2022-03-13
Start date
2022-02-24
Completion date
Unknown
Last updated
2022-04-04

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

Interventions

Intervention 1: Intervention group: The intervention consists of administration of probiotics to newly diagnosed children with type 1 diabetes aged 6-18 years for a six month period. Products are manu

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Newly diagnosed children with type1diabetes mellitus aged between 6-18 years old.

Exclusion criteria

Exclusion criteria: Presence of comorbid conditions like significant cardiac, hepatic or renal disease Presence of immunodeficiency Allergy to probiotics Patients not willing to continue participating in the study

Design outcomes

Primary

MeasureTime frame
Fasting c-peptide levels. Timepoint: before intervention and then every 3 months up to one year. Method of measurement: laboratory.;HbA1c levels. Timepoint: before intervention and then every 3 months up to one year. Method of measurement: laboratory.

Secondary

MeasureTime frame
Anthropometric parameters. Timepoint: before intervention and then every 3 months up to one year. Method of measurement: digital scale.;Insulin requirements. Timepoint: before intervention and then every 3 months up to one year. Method of measurement: asking patient and based on prescribed insulin for glycemic control.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNasrin Moazzen

Mashhad University of Medical Sciences

moazzenn@mums.ac.ir0098 51 38049

Outcome results

None listed

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