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IRCT20170201032346N3 IRCT 2019-03-14 Ramsar Campus, Mazandaran University of Medical Sciences Evaluation of Bifidobacterium Animalis Spp. Lactis oral suspension effect on crying/fussing time and changes of gut microbiota in formula-fed infants with colic Evaluation of Bifidobacterium Animalis Spp. Lactis oral suspension effect on crying/fussing time and changes of gut microbiota in formula-fed infants with colic: A Double blind randomized clinical trial 2019-04-21 anticipated 50 Complete https://irct.ir/trial/38224 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: participant are randomized with Distance randomization method. two groups of 25 patients are assigned to treatment or placebo group. each patient is assigned to a unique code provided by Distance randomization service from www.sealedenvelope.com, Blinding description: Placebo are provided by the company producing the product. in terms of appearance drug and placebo are identical. caregivers prescribe the drug. the research technician is assigned to lead two arms of study based on patient's assigned group. 3 Infantile colic, probiotic, intestinal dysbiosis, microbiota, bifidobacterium lactis. 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 drops, four times daily for 28 days. Intervention 2: Control group: purchased placebo from the probiotic producing company (Zist Takhmir, Iran) is used for 28 days. 5 drops are given four times daily. Yes - There is a plan to make this available What will be shared: all collected deidentified data for primary and secondary outcome measures are going to be shared When: after publishing the study, data are going to be available To whom: data are going to be available to all researchers and clinician irrespective to their employment sector Conditions: permission are granted upon request for secondary and meta-analysis Where to obtain: requests are gathered through principle researcher's e-mail address How to obtain: upon verification of request and reason data are given in three month. Comments:
public Firouzi Hossein
No.20 ,Taleghani Ave., Ramsar.
Ramsar Iran (Islamic Republic of) 4691786953 +1 155230181 firoozihosein@mazums.ac.ir Ramsar Campus, Mazandaran University of Medical Sciences scientific Firouzi Hossein
No.20 ,Taleghani Ave., Ramsar.
Ramsar Iran (Islamic Republic of) 4691786953 +1 155230181 firoozihosein@mazums.ac.ir Ramsar Campus, Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) exclusive formula feeding less than 7 weeks of age diagnosis of colic based on ROME IV criteria accepting informed consent no limit 49 days Both 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 R10.4 R10.4 Treatment - Drugs Placebo 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 drops, four times daily for 28 days Control group: purchased placebo from the probiotic producing company (Zist Takhmir, Iran) is used for 28 days. 5 drops are given four times daily. 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. 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: متر. Ramsar Campus, Mazandaran University of Medical Sciences Approved 2019-03-12 Ethics committee of Ramsar Campus, Mazandaran University of Medical Sciences No.20, Taleghani Ave, Ramsar Ramsar Mazandaran Iran (Islamic Republic of) Approved 2019-03-12 Ethics committee of Ramsar Campus, Mazandaran University of Medical Sciences No.20, Taleghani Ave, Ramsar Ramsar Mazandaran Iran (Islamic Republic of)