Effect of dietary interventions based on Persian medicine on infantile gastroesophageal reflux.
- Conditions
- Infantile Gastroesophageal Reflux.Other specified perinatal digestive system disorders
- Registration Number
- IRCT20170701034828N1
- Lead Sponsor
- Vice chancellor for research, Shahed University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
Infants under 5 months old (girls and boys)
Exclusive breastfeeding
Clinically confirmation of infantile GER by the pediatric gastroenterologist
Score of Gastroesophageal Reflux Questionnair - Infantile (GSQ-I questionnaire) above 16 (the min score for confirm GER)
Any diagnosed disease of mother or infant that needs medical or surgical therapy
Any other type of gastrointestinal disease such as hiatal hernia, erosive esophagitis, etc in infants
Necessity of medical treatment for infantile reflux at the bigining or through the study
Any diagnosed disease of mother or infant that due to it breastfeeding is forbidden
Any consumption of effective medicine on GER in infants, such as Proton pump inhibitors, H2-receptor antagonists, etc
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of Infantile Gastroesophageal Reflux signs. Timepoint: Before intervention, 2 weeks after intervention, the end of intervention (4th week), 6th week. Method of measurement: GERD Symptoms Questionnaire for infants (GSQ-I).;Severity of Infantile Gastroesophageal Reflux signs. Timepoint: Before intervention, 2 weeks after intervention, the end of intervention (4th week), 6th week. Method of measurement: GERD Symptoms Questionnaire for infants (GSQ-I).
- Secondary Outcome Measures
Name Time Method Infant weight. Timepoint: Before intervention, The end of intervention (4th week). Method of measurement: Baby scale, Gramme.;Infant height. Timepoint: Before intervention, The end of intervention (4th week). Method of measurement: Measuring board, centimeter.;Nursing mothers' gastric temperament. Timepoint: Before intervention, The end of intervention (4th week). Method of measurement: Gastric temperament check list.