The comparison of the efficacy of a synbiotic drop with dimeticone drop in the treatment of infantile colic

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160827029535N6

Enrollment

Registered

2019-09-13

Start date

2019-09-23

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Infantile colic. Indeterminate colitis

Interventions

Intervention 1: Group A intervention: They will recieve nonpharmacological treatment +a synbiotic containing “Bifidobacterium infantis”, “Lactobacillus reuteri” and “Lactobacillus rhamnosus”Interventi

Eligibility

Sex/Gender

All

Age

No minimum to 5 Months

Inclusion criteria

Inclusion criteria: Any healthy infant Under 5 months of age Diagnosed as colic according to the new Rome IV criteria

Exclusion criteria

Exclusion criteria: Any acute or chronic diseases, especially GI tract conditions Taking antibiotics or supplements of probiotics or prebiotics since 1 week prior to the study Not fulfilling the new Rome IV criteria Parents' unwilling to participate in the study. Protein milk allergy

Design outcomes

Primary

Measure	Time frame
Recovery rate of infantile colic symptoms and signs. Timepoint: One week and one month after beginning of intervention. Method of measurement: Questionnaire.;Complications of each drug during intervention. Timepoint: One week and one month after beginning of intervention. Method of measurement: Questionnaire.	—

Secondary

Measure	Time frame
Recovery rate of infantile colic symptoms and signs. Timepoint: One week one month after beginning of intervention. Method of measurement: Questionnaire.;Complications of each drug ( diarrhea, vomiting and skin rush) during intervention. Timepoint: 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

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

Outcome results

None listed

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