Effect of oral probiotic intake on immune mechanisms in children with newly diagnosed type 1 diabetes mellitus

Effect of Oral Probiotics Supplementation on Immune-regulatory Markers in Children with New Onset Type One Diabetes Mellitus: A Randomised, Double-Blind Placebo Control Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/013581

Enrollment

Registered

2018-05-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Type 1 Diabetes Mellitus

Interventions

Intervention1: Probiotic preparation (Vivomixx Capsules) â?¢Composition: Vivomixx Capsules contains the â??Original De Simone Formulationâ?? (a mix of 8 strains of bacteria, namely, L. plantarum DSM 2

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children with type 1 diabetes mellitus, aged 2 to 12 years. AND 2. Diagnosed with type 1 diabetes mellitus in last six months. AND 3. Enrolled in pediatric diabetes clinic for follow-up at PGIMER, Chandigarh AND 4. Parent or legal guardian willing to give informed consent for the study.

Exclusion criteria

Exclusion criteria: 1. Chronic medical condition that could affect gut microbiota (for example, Crohnâ??s disease, cystic fibrosis, irritable bowel syndrome, etc.) 2. Positive screening test for Celiac disease 3. Receiving medications or supplements that could affect gut microbiota in last 15 days (for example: broad spectrum antibiotics, pro/prebiotics, laxatives, etc.) 4. Children having diarrhea in last 2 weeks.

Design outcomes

Primary

Measure	Time frame
1. Change in regulatory-T cells (Tregs) percentage (out of total CD4+ T cells) after 6 months of probiotic treatment. 2. Change in plasma interleukin-10 (IL-10) levels after 6 months of probiotic treatment. Timepoint: Base line and at 6 months of intervention	—

Secondary

Measure	Time frame
1. Change in serum C -peptide levels. 2. Change in HbA1C. 3. Change in insulin dose (U/kg/day). 4. Change in blood glucose variability 5. GAD65, IAA, IA2 Antibody levels Timepoint: Base line and at 6 months of intervention	—

Countries

India

Contacts

Public ContactLokesh M N

Post Graduate Institute of Medical Education and Research, Chandigarh

drrakesh.pgi@gmail.com91-7087008480

Outcome results

None listed

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