The therapeutic effect of probiotics in children with allergy to cow's milk protein

Clinical trial of the therapeutic effect of probiotics in children with allergy to cow's milk protein

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017043033595N2

Enrollment

126

Registered

2017-07-02

Start date

2016-03-20

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Adverse effects, not elsewhere classified. Allergy, unspecified

Interventions

Intervention 1: The control group receives the same package containing Aptamil Pepti Junior formula one sachet per day for 4 weeks. Intervention 2: For the intervention group, in addition to diet prot

Placebo

Treatment - Other

The control group receives the same package containing Aptamil Pepti Junior formula one sachet per day for 4 weeks

For the intervention group, in addition to diet protocol, one sachet Protexin probiotic made by Health care co. is administered daily for 4 weeks

Eligibility

Sex/Gender

All

Age

No minimum to 12 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria: age 1-12 months; cow's milk allergy Exclusion criteria: consuming probiotics and prebiotics within 2 months, receiving antibiotics within 2 weeks, evidence of systemic infection on physical exam, positive stool culture for pathogens; febrile infants; Hirschsprung's disease,; coagulopathy, systemic disease, consumption of formula

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Calprotectin. Timepoint: 0, 2, 4, 8, 12, 16 weeks. Method of measurement: ELIZA.;Bacterial growth in culture. Timepoint: 0, 4, 16 weeks. Method of measurement: Stool culture.;WBC, RBC and occult blood. Timepoint: 0, 2, 4, 8, 12, 16 weeks. Method of measurement: Stool analysis.	—

Secondary

Measure	Time frame
The number of stools per week. Timepoint: 0, 2, 4, 8, 12, 16 weeks. Method of measurement: Interview with infant's Mother.;The number of mucoid per week. Timepoint: 0, 2, 4, 8, 12, 16 weeks. Method of measurement: Interview with infant's Mother.;Number of blood in the stool per week. Timepoint: 0, 2, 4, 8, 12, 16 weeks. Method of measurement: Interview with infant's Mother.;Pain duration in week (minute). Timepoint: 0, 2, 4, 8, 12, 16 weeks. Method of measurement: Interview with infant's Mother.	—

Measure

Time frame

The number of stools per week. Timepoint: 0, 2, 4, 8, 12, 16 weeks. Method of measurement: Interview with infant's Mother.;The number of mucoid per week. Timepoint: 0, 2, 4, 8, 12, 16 weeks. Method of measurement: Interview with infant's Mother.;Number of blood in the stool per week. Timepoint: 0, 2, 4, 8, 12, 16 weeks. Method of measurement: Interview with infant's Mother.;Pain duration in week (minute). Timepoint: 0, 2, 4, 8, 12, 16 weeks. Method of measurement: Interview with infant's Mother.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHassan Karami, MD

Mazandaran University of Medical Sciences

hakarami@mazums.ac.ir+98 11 3334 2334

Outcome results

None listed

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