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Investigating the Effect of Synbiotics on Inflammatory Indicators

Investigating the Effect of Synbiotic Supplementation on Inflammatory Indices in Children with Sepsis Hospitalized in the Intensive Care Unit in comparison with placebo

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230523058266N1
Enrollment
27
Registered
2023-10-30
Start date
2023-11-22
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Sepsis. Sepsis, unspecified organism

Interventions

Intervention 1: Intervention group:Kidilact synbiotic supplement containing 10 strains of bacteria produced by zisttakhmir company with a dose of 2 sachets daily for 7 days. Intervention 2: Control gr

Sponsors

Vice President of Research and Technology, Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 10 Years

Inclusion criteria

Inclusion criteria: Any Patient admitted to the Pediatric Intensive Care Unit with a Diagnosis of Sepsis and Possibility of Hospitalization for more than 4 Days in the PICU children aged 1 month to 10 years consent of parent to participation of their children to study

Exclusion criteria

Exclusion criteria: Immunodeficiency or Malignancy steroid Therapy or Immunotherapy Congenital Abnormalities Incompatible with life Previous Gastrointestinal Surgery in the last month Ulcerative Colitis Short Bowel Syndrome

Design outcomes

Primary

MeasureTime frame
Interleukin-6. Timepoint: The beginning of the study (before the start of the intervention) and the 7th day after the start of taking the synbiotic supplement. Method of measurement: Interleukin 6 ELISA kit.

Secondary

MeasureTime frame
C reactive protien. Timepoint: The beginning of the study (before the start of the intervention), 7 days after the start of taking the synbiotic supplement. Method of measurement: Measurement of serum levels.;Tumor necrosis factor. Timepoint: The beginning of the study (before the start of the intervention), 7 days after the start of taking the synbiotic supplement. Method of measurement: Measurement of serum levels.;Erythrocyte sedimentation rate. Timepoint: The beginning of the study (before the start of the intervention), 7 days after the start of taking the synbiotic supplement. Method of measurement: Measurement of serum levels.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Roudi

Mashhad University of Medical Sciences

RoudiF@mums.ac.ir+98 51 3189 1509

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026