Health Condition 1: E40-E46- Malnutrition
Conditions
Interventions
Intervention1: SPORLAC SYRUP: ARM A will receive syrup which contain 300 million CFU of bacillus coagulans per 5ml TDS in double blind randomized fashion for a duration of 3 months.
Control Interventi
Sponsors
Madeline J Fernandes
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 1-5years 2.Evidence of moderate malnutrition (having a weight-for-height z-score of -3.0 to less than -2.0)
Exclusion criteria
Exclusion criteria: 1.Age 5yrs, 2.History suggestive of Chronic inflammatory bowel diseases, 3.Immunocompromised /HIV positive. 4.Any evidence of Malignancy. 5.History and clinical findings suggestive of Metabolic diseases 6.History and clinical findings suggestive of Chronic respiratory tract diseases including respiratory allergies and cystic fibrosis. 7.Malformations of gastrointestinal or urinary or respiratory tract on clinical or radiological findings. 8.History of respiratory or gastrointestinal or urinary tract surgery. 9.History and Clinical findings suggestive of Congenital cardiac defects. 10.History suggestive of challenge-proved food allergy and Food intolerance. 11.Normal nourished (-1 12.History of use of antibiotics or pre/pro/symbiotic or immune stimulating products in the 2 weeks before the enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of episodes of gastrointestinal or respiratory tract infections during the period from day 0 to day 90Timepoint: Number of episodes of gastrointestinal or respiratory tract infections during the period from day 0 to day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Emergency Department Medical visit if child has symptoms of gastrointestinal and respiratory tract infectionTimepoint: day o to day 90;Number of children experiencing at least one episode of AGI or RTI in 30 daysTimepoint: day 0 to day 90;Number of children experiencing at least one episode of AGI or RTI in 60 daysTimepoint: day 0 to day 90;Number of children experiencing at least one episode of AGI or RTI in 90 daysTimepoint: day 0 to day 90;Number of children with diarrheal episodesTimepoint: day 0 to day 90;Number of children with lower respiratory tract infections, including pneumonia, bronchitis, and bronchiolitisTimepoint: day o to day 90;Number of children with upper respiratory tract infection, including rhinitis, pharyngitis, sinusitis, otitis, and the common coldTimepoint: day 0 to day 90;Number of children with vomiting episodesTimepoint: day 0 to day 90;Number of days of preschool lost by childrenTimepoint: day o to day 90;Number of days of work lost by the parentsTimepoint: day 0 to day 90;Number of gastrointestinal infections lasting longer than 2 daysTimepoint: day 0 to day 90;Number of respiratory tract infections lasting longer than 3 days.Timepoint: day 0 to day 90;Number of severe diarrhea episodes.Timepoint: day o to day 90;Total days of illnessTimepoint: day 0 to day 90;Total Number of Days with respiratory and gastrointestinal SymptomsTimepoint: day o to day 90 | — |
Countries
India
Contacts
Public ContactMadeline Janice Fernandes
Byramjee jheejheeboy government medical college
Outcome results
None listed