Role of good bacteria (probiotic) intake on sugar control in children with type 1 diabetes mellitus

Effect of oral probiotic intake on glycemic control in children with type 1 diabetes mellitus: a randomised, double-blind placebo control trial - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/06/008725

Enrollment

100

Registered

2017-06-01

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 VSL#3: Participants shall be given probiotic (VSL#3) in a dose of one gel capsule orally/day for 3 months duration Control Intervention1: Placebo gel caps: Identical looking g

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 recently with in six months of duration. 3. Enrolled in pediatric diabetes clinic/diabetes follow up clinic of PGIMER, Chandigarh

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 diarrhoea in last 2 weeks. 5. Parents/legal guardians unwilling to give consent.

Design outcomes

Primary

Measure	Time frame
Change in HbA1cTimepoint: Baseline to 3 months after intervention	—

Secondary

Measure	Time frame
1. Change in serum C -peptide levels 2. Change in insulin dose (Units/kg/day) 3. Change in blood glucose variability Timepoint: Baseline to 3 months after intervention	—

Countries

India

Contacts

Public ContactRakesh Kumar

Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh

drrakesh.pgi@gmail.com

Outcome results

None listed

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