Efficacy of Hypoallergenic diet on infant's reflux

Efficacy of Hypoallergenic diet and administration of Ranitidine in treatment of Gastroesophageal reflux disease in infants one month to one years old

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015042714882N3

Enrollment

Registered

2016-02-16

Start date

2014-04-21

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

Gastroesophaseal reflux. Gastro-oesophageal reflux disease without oesophagitis(Oesophageal reflux NOS)

Interventions

Intervention 1: The treatment group will be eliminate allergens from mother's diet for 2 weeks. Hypoallergenic diet was defined, diet free of milk and dairy products, cow’s meat, peanut, fish and soy.

Lifestyle

Treatment - Drugs

The treatment group will be eliminate allergens from mother's diet for 2 weeks. Hypoallergenic diet was defined, diet free of milk and dairy products, cow’s meat, peanut, fish and soy.

The Ranitidine consumer group will receive Ranitidine 10 mg per kg per day divided to 2 doses for 2 week. (Ranitidine syrup 15 mg per ml, Alhavi Pharmaceutical Company)

Eligibility

Sex/Gender

All

Age

1 Months to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:1 month to 1 year infants with vomiting or regurgitation plus one of following symptoms, Irritability; Insufficient weight gain; Respiratory symptoms. Exclusion criteria: Renal disease; urinary tract infection(UTI); CNS (Central nerves system); Respiratory symptoms; Apnea; Cyanosis; Respiratory distress.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Frequency of vomiting per day. Timepoint: Two weeks after intervention. Method of measurement: Counting the episode of vomiting per day. Asking question from mothers and recording in questionnaire.;Volume of vomiting. Timepoint: Two weeks after intervention. Method of measurement: Asking question from mother about volume of vomiting and recording in questionnaire.	—

Secondary

Measure	Time frame
Irritability severity. Timepoint: Two weeks after intervention. Method of measurement: Asking question from mothers and recording in questionnaire.;Weight gain. Timepoint: Two weeks after intervention. Method of measurement: Weighing patient.;Respiratory symptoms. Timepoint: Two weeks after intervention. Method of measurement: Asking question from mothers and recording in questionnaire.;Arching. Timepoint: Two weeks after intervention. Method of measurement: Asking question from mothers and recording in questionnaire.	—

Measure

Time frame

Irritability severity. Timepoint: Two weeks after intervention. Method of measurement: Asking question from mothers and recording in questionnaire.;Weight gain. Timepoint: Two weeks after intervention. Method of measurement: Weighing patient.;Respiratory symptoms. Timepoint: Two weeks after intervention. Method of measurement: Asking question from mothers and recording in questionnaire.;Arching. Timepoint: Two weeks after intervention. Method of measurement: Asking question from mothers and recording in questionnaire.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Nazanin Zibanejad

Child Growth and Development Center and Pediatric Group of Isfahan University of Medical Sciences

famouri@med.mui.ac.ir+98 31 3386 6266

Outcome results

None listed

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