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IRCT201301314976N2 IRCT 2013-05-07 Vice chancellor for research, Mashhad University of Medical Sciences A new symbiotic may improve weight gain in infants with cow’s milk allergy Effect of lactobacillus GG on gastrointestinal symptoms of infants with cow`s milk protein allergy 2010-01-03 anticipated 32 Complete https://irct.ir/trial/5338 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 0 (exploratory trials) Cow milk protein allergy. Intervention 1: The control group received placebo without probiotics which are match for size, shape, and volume of contents and manufactured by the same company, daily for 4 weeks. Intervention 2: The study group will receive a synbiotic containing 1 billion Colony Forming Units (CFU) of ProtexinR Restore: a mixture of Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis, Lactobacillus bulgaricus and FOS (Protexin healthcare, Somerset, United Kingdom), in the form of freeze dried powder will administer daily for 4 weeks.
public
scientific Hamid Ahanchian
Ghaem hospital
Mashhad Iran (Islamic Republic of) +98 51 1801 2522 Ahanchianh@mums.ac.ir Ghaem hospital Iran (Islamic Republic of) Inclusion criteria: 1-12 months-old infants with the clinical symptoms of cow's milk protein allergy including rectal bleeding, diarrhea, vomiting and evidences of colitis; a good general condition, breast milk feeding and cow's milk consuming mother. The infants are excluded from the study if they had a known immune deficiency, gastro intestinal disease, positive stool culture, coagulopathy or are receiving any type of antibiotic therapy. no limit 1 year Both K90.4 Malabsorption due to intolerance to: carbohydrate-fat-protein-starch Placebo Treatment - Drugs The control group received placebo without probiotics which are match for size, shape, and volume of contents and manufactured by the same company, daily for 4 weeks The study group will receive a synbiotic containing 1 billion Colony Forming Units (CFU) of ProtexinR Restore: a mixture of Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis, Lactobacillus bulgaricus and FOS (Protexin healthcare, Somerset, United Kingdom), in the form of freeze dried powder will administer daily for 4 weeks. Severity of gastrointestinal symptoms. Timepoint: At the beginning of the study, 3 months after intervention. Method of measurement: The number of vomiting, colic, rectal bleeding and diarrhea. Weight. Timepoint: At the beginning of the study, 3 months after intervention. Method of measurement: Gram. Head circumference. Timepoint: At the beginning of the study, 3 months after intervention. Method of measurement: centimeter. Body length. Timepoint: At the beginning of the study, 3 months after intervention. Method of measurement: centimeter. Vice chancellor for research, Mashhad University of Medical Sciences Approved 2010-09-23 Mashhad University of Medical Sciences Ethics Committee Ghoreish bulding, Daneshgah street Mashhad Iran (Islamic Republic of)