Supplementation of High-Strength Oral Probiotics Improves Immune Regulation and Preserves Beta Cells among Children with New-Onset Type 1 Diabetes Mellitus : A Randomised, Double-Blind Placebo Control Trial
© 2024. The Author(s), under exclusive licence to Dr. K C Chaudhuri Foundation..
OBJECTIVES: To investigate the mechanism of glycemic control in children with type 1 diabetes (T1D) following high-strength probiotics supplementation by assessing immune-regulatory markers.
METHODS: In this single-centre randomised double-blinded placebo-controlled study, children with new-onset T1D on regular insulin therapy were randomised into probiotic or placebo groups with 30 children each. The probiotics group received oral powder of Vivomixx®, and the placebo group received corn starch for six months. The primary outcome parameters included induced T regulatory cells (i-Tregs) percentage, insulin autoantibodies (IAA), insulinoma associated 2 autoantibodies (IA2), glutamic acid decarboxylase autoantibodies (GAD 65) and plasma interleukin-10 (IL-10) levels. The secondary outcome variables were changes in plasma C-peptide levels and glycemic control parameters.
RESULTS: Twenty-three children in the placebo group and 27 in the probiotic group completed the study. There was a significant increase in the percentage of iTregs (3.40 in the probiotic vs. 2.46 in the placebo group; p = 0.034). Median glycated hemoglobin (HbA1c) levels significantly decreased from 68 mmol/mol (8.35%) in the placebo group to 60 mmol/mol (7.55%) in the probiotic group (p = 0.017). Median C-peptide levels were significantly higher in probiotics (0.72 ng/ml) vs. placebo group (0.11 ng/ml) (p = 0.036). The plasma IL-10 levels significantly increased in the probiotic group after six months of treatment (p = 0.002).
CONCLUSIONS: The high-strength probiotics improved the immunoregulatory milieu, thereby preserving the beta-cell function and better glycemic control.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
Indian journal of pediatrics - (2024) vom: 01. Apr. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lokesh, M N [VerfasserIn] |
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| Links: |
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| Themen: |
High-strength probiotics |
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| Anmerkungen: |
Date Revised 01.04.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1007/s12098-024-05074-5 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM370473264 |
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| 245 | 1 | 0 | |a Supplementation of High-Strength Oral Probiotics Improves Immune Regulation and Preserves Beta Cells among Children with New-Onset Type 1 Diabetes Mellitus |b A Randomised, Double-Blind Placebo Control Trial |
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| 500 | |a Date Revised 01.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © 2024. The Author(s), under exclusive licence to Dr. K C Chaudhuri Foundation. | ||
| 520 | |a OBJECTIVES: To investigate the mechanism of glycemic control in children with type 1 diabetes (T1D) following high-strength probiotics supplementation by assessing immune-regulatory markers | ||
| 520 | |a METHODS: In this single-centre randomised double-blinded placebo-controlled study, children with new-onset T1D on regular insulin therapy were randomised into probiotic or placebo groups with 30 children each. The probiotics group received oral powder of Vivomixx®, and the placebo group received corn starch for six months. The primary outcome parameters included induced T regulatory cells (i-Tregs) percentage, insulin autoantibodies (IAA), insulinoma associated 2 autoantibodies (IA2), glutamic acid decarboxylase autoantibodies (GAD 65) and plasma interleukin-10 (IL-10) levels. The secondary outcome variables were changes in plasma C-peptide levels and glycemic control parameters | ||
| 520 | |a RESULTS: Twenty-three children in the placebo group and 27 in the probiotic group completed the study. There was a significant increase in the percentage of iTregs (3.40 in the probiotic vs. 2.46 in the placebo group; p = 0.034). Median glycated hemoglobin (HbA1c) levels significantly decreased from 68 mmol/mol (8.35%) in the placebo group to 60 mmol/mol (7.55%) in the probiotic group (p = 0.017). Median C-peptide levels were significantly higher in probiotics (0.72 ng/ml) vs. placebo group (0.11 ng/ml) (p = 0.036). The plasma IL-10 levels significantly increased in the probiotic group after six months of treatment (p = 0.002) | ||
| 520 | |a CONCLUSIONS: The high-strength probiotics improved the immunoregulatory milieu, thereby preserving the beta-cell function and better glycemic control | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a High-strength probiotics | |
| 650 | 4 | |a Induced Tregs | |
| 650 | 4 | |a Randomised controlled trial | |
| 650 | 4 | |a Type 1 diabetes | |
| 700 | 1 | |a Kumar, Rakesh |e verfasserin |4 aut | |
| 700 | 1 | |a Jacob, Neenu |e verfasserin |4 aut | |
| 700 | 1 | |a Sachdeva, Naresh |e verfasserin |4 aut | |
| 700 | 1 | |a Rawat, Amit |e verfasserin |4 aut | |
| 700 | 1 | |a Yadav, Jaivinder |e verfasserin |4 aut | |
| 700 | 1 | |a Dayal, Devi |e verfasserin |4 aut | |
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