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Effect of Probiotic consumption in diabetic patients

Effect of oral probiotic consumption on controlling blood sugar and inflammatory factor in type 1 diabetic patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240617062159N1
Enrollment
60
Registered
2024-08-29
Start date
2024-09-22
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

type 1 diabetic. Type 1 diabetes mellitus

Interventions

Intervention 1: Intervention group: Patients are given 1 BioDiab capsule from TAKGENE Company containing strains of Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium lactis, Bifidobacter

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Children aged 6 to 18 years with type 1 diabetes, at least two years have passed since the onset of diabetes. 10% = HbA1c HbA1c = 6.5%

Exclusion criteria

Exclusion criteria: Patients with kidney, Gastrointestinal, Respiratory disease. Type 1 diabetic patients who have a history of taking anti-inflammatory drugs, antibiotics, or immunosuppressive drugs during the month before the start of the study. Type 1 diabetic patients who have a history of consuming products containing probiotics, prebiotics or antioxidants during the month before the start of the study. Patients who have a history of participation in similar plans of probiotic effect in blood sugar control.

Design outcomes

Primary

MeasureTime frame
High-sensitivity C-reactive Protein (hs CRP). Timepoint: At the beginning of the study, at the end of the 3rd, 6th and 9th months. Method of measurement: Enzyme-linked immuno_sorbent assay (ELIZA).;Hemoglobin A1C (HbA1c). Timepoint: At the beginning of the study, at the end of the 3rd, 6th and 9th months. Method of measurement: Fluorescence Immuno.

Secondary

MeasureTime frame
Blood pressure (Bp). Timepoint: At the beginning and end of the study. Method of measurement: Dial sphygmomanometer.;Thyroid-Stimulating Hormone (TSH). Timepoint: At the beginning and end of the study. Method of measurement: Enzyme-linked immuno_sorbent assay (ELIZA).;Thyroxine (T4). Timepoint: At the beginning and end of the study. Method of measurement: Enzyme-linked immuno_sorbent assay (ELIZA).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Orouji Boroujeni

Mashhad University of Medical Sciences

oroujiz3@mums.ac.ir+98 51 3871 3801

Outcome results

None listed

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