Evaluation of Bifidobacterium Animalis Spp. Lactis oral suspension effect on crying/fussing time and changes of gut microbiota in formula-fed infants with colic
- Conditions
- Infantile colic, probiotic, intestinal dysbiosis, microbiota, bifidobacterium lactis.R10.4
- Registration Number
- IRCT20170201032346N3
- Lead Sponsor
- Ramsar Campus, Mazandaran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
exclusive formula feeding
less than 7 weeks of age
diagnosis of colic based on ROME IV criteria
accepting informed consent
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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: ???.