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IRCT20190304042914N1 IRCT 2019-05-25 Babol University of Medical Sciences Assessment the effect of a drug in the treatment of abdominal pain in children Assesment the effect of synbiotic in the treatment of functional abdominal pain in children 2019-02-19 anticipated 64 Complete https://irct.ir/trial/38030 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done using a computer and a random number system. Patients are divided into two groups A and B and drugs are coded, Blinding description: In this double blind study, both participants and searcher are unaware of the allocation of study groups to the two groups that receive the drug and the group B receiving the placebo. 2 Functional abdominal pain. Intervention 1: Intervention group: Daily, 2 Sinobiotic sachets are consumed every 12 hours soluble in water or juice for one month. Intervention 2: Control group:Daily, 2 Placebo are consumed every 12 hours soluble in water or juice for one month. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Azadeh gholizadeh
No 19, Amirkola Children’s Hospital
Babol Iran (Islamic Republic of) 4731741151 +98 11 3235 4951 gholizadeh.a.84@gmail.com Babol University of Medical Sciences scientific Azadeh Gholizadeh
No 19, Amirkola Children’s Hospital
Babol Iran (Islamic Republic of) 4731741151 +98 11 3235 4951 gholizadeh.a.84@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) FAP diagnosis based on Rome III criteria 5 years 14 years Both Immunodeficiency Consumption of probiotics or prebiotics within 7 days before participating in the study Chronic underlying disease Malignancy The presence of red flags includes a pain that awakens the baby Continuous pain of RUQ or RLQ Vomiting (biliary, frequent, periodic, or disturbing for the physician) Fever without cause Urogenital Symptoms Dysphagia Severe chronic diarrhea or Nocturnal diarrhea Gastrointestinal bleeding Unwanted weight loss Downtrend in the growth curve Delayed puberty Family history of IBD Celiac and PUD Localized tenderness in RUQ or RLQ Localized mass Splenomegaly Jaundice CVA tenderness Arthritis Vertebral tenderness Disease in the perianal area Abnormal or unreasonable findings in the examination Hematochezia Anemia Hepatomegaly Antibiotic use in the last month R10.4 Other and unspecified abdominal pain Treatment - Drugs Treatment - Drugs Intervention group: Daily, 2 Sinobiotic sachets are consumed every 12 hours soluble in water or juice for one month. Control group:Daily, 2 Placebo are consumed every 12 hours soluble in water or juice for one month. Frequency of pain. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: check list. Number of absentee days from school. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: Check list. Pain intensity. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: Face scaling. Babol University of Medical Sciences Approved 2019-02-19 Ethics Committee of Babol University of Medical Sciences Ganjafroz Street Babol Mazandaran Iran (Islamic Republic of)