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Lactobacillus rhamnosus GG (ATCC 53103) in the treatment of infantile colic

Assay of IL6 and TNF alfa in infantile colic treated with Lactobacillus GG

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87937882
Enrollment
60
Registered
2021-09-09
Start date
2021-07-23
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Infantile colic Signs and Symptoms Colic, infantile

Interventions

At enrollment, each infant underwent a medical examination by a pediatrician, and parents completed a questionnaire to obtain data concerning the type of delivery, birth weight, and gestational age. T

Sponsors

Dicofarm
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Infants aged between 2 and 10 weeks 2. Gestational age between 37 and 40 weeks 3. Birth weight between 2700 and 4200 g 4. Exclusively breastfed

Exclusion criteria

Exclusion criteria: 1. Clinical evidence of chronic illness or gastrointestinal disorders 2. Received antibiotics or probiotics in the week preceding recruitment

Design outcomes

Primary

MeasureTime frame
Crying time per day measured by parents using a structured diary for the 28 days of the study period

Secondary

MeasureTime frame
Interleukin 6 and tumor necrosis factor alfa evaluated with real-time PCR at day 0 and day 28

Countries

Italy

Outcome results

None listed

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