Infantile colic, probiotic, intestinal dysbiosis, microbiota, bifidobacterium lactis. R10.4
Conditions
Interventions
Intervention 1: Intervention group: the product which is used in this study is BB Care (Zist takhmir, Iran) oral suspension which contain 1x 108 CFU per milliliter. patients are advised to take 5 drop
Sponsors
Ramsar Campus, Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
No minimum to 49 Days
Inclusion criteria
Inclusion criteria: exclusive formula feeding less than 7 weeks of age diagnosis of colic based on ROME IV criteria accepting informed consent
Exclusion criteria
Exclusion criteria: birth weight lower than 2500grams preterm birth (Gestational age<37 weeks) five minute Apgar score <7 breast feeding Central venous catheter severe medical condition valvular heart disease prematurity reduction in growth or weight reduction of more than 100gram from birth to the last measurement neurological disease known of suspected food allergy gastroesophageal reflux disease Probiotic, prebiotic, antibiotic or acid suppressing agents in the past two weeks history of fever or infectious disease in the past two weeks progressive systemic infection congenital infection chronic bowel disease, e.g. cystic fibrosis and primary pancreatic insufficiency primary or secondary digestive tract malformations, e.g. esophageal atresia, intestinal atresia, short bowel syndrome, malrotation metabolic disease genetic and chromosomal disease primary or secondary immunodeficiency syndrome suspecting noncompliance or caregiver's inability to act in accordance to the given protocol previous participation in medical research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of infant Crying/fussing expressed in minutes. Timepoint: before and at 7, 14, 21 and 28 days after initiation of intervention. Method of measurement: according to Barr diaries.;Fecal microbiota of infants. Timepoint: before and 28 days after the initiation of the intervention. Method of measurement: 16s rRNA qPCR and Pyrosequencing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight gain. Timepoint: before and 28 days after the intervention. Method of measurement: scale.;Defecation, times per day. Timepoint: prior and 0, 7, 14, 21 and 28 days after the initiation of intervention. Method of measurement: questionnaire.;Length growth. Timepoint: before and 28 days after the intervention. Method of measurement: ???. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFirouzi Hossein
Ramsar Campus, Mazandaran University of Medical Sciences
Outcome results
None listed