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The Comparison of two synbiotics in the treatment of infantile colic

The comparison of the efficacy of a synbiotic containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus” with a synbiotic containing “Bifidobacterium lactis” in the treatment of infantile colic

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160827029535N4
Enrollment
70
Registered
2018-02-07
Start date
2018-04-19
Completion date
Unknown
Last updated
2018-03-26

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

Conditions

Infantile colic. Abdominal pain

Interventions

Intervention 1: Group A intervention: Administrating a synbiotic containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus”. Zist-Takhmir company has produces this d

Sponsors

Investigator
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Days to 4 Months

Inclusion criteria

Inclusion criteria: 1-Breast-fed infants with the age of 3 weeks to 3 months 2- Fulfilling the Wessel’s criteria including: crying for at least 3 hours per day, for at least 3 days per week, and for at least 3 weeks from birth to 3-4 months of age or the characteristic clinical manifestations of colic including irritability, crying ,flushing and passage of a large amount of bowel gas along with defecation; irritability and crying especially in the evening and increased bowel sounds in auscultation 3-No failure to thrive .

Exclusion criteria

Exclusion criteria: 1-any acute or chronic diseases, especially GI tract conditions 2- use of medications except routine supplements

Design outcomes

Primary

MeasureTime frame
Response rate of infantile colic symptoms and signs. Timepoint: Before intervention, one week and one month after beginning of intervention. Method of measurement: Questionnaire.

Secondary

MeasureTime frame
Complications of each synbiotic during intervention including vomiting, constipation, skin reactions and infections. Timepoint: Before intervention,one week and one month after intervention. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPeymaneh Alizadeh Taheri

Tehran University of Medical Sciences. Bahrami Hospital

p.alizadet@yahoo.com+98 21 7301 3420

Outcome results

None listed

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