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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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT201301314976N2
Enrollment
32
Registered
2013-05-07
Start date
2010-01-03
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

Cow milk protein allergy. Malabsorption due to intolerance to: carbohydrate-fat-protein-starch

Interventions

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: T
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, B

Sponsors

Vice chancellor for research, Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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