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IRCT20210525051398N1 IRCT 2021-05-30 Islamic Azad University The effect of probiotic use in children with functional constipation The effect of probiotic use in children with functional constipation 2021-05-31 anticipated 150 Complete https://irct.ir/trial/56464 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Limited randomization with 75-person blocks is performed by the consulting pharmacist using a random number table of Random Allocation Software, Blinding description: This study is a double-blind clinical trial study performed on children with chronic functional constipation referred to the pediatric clinics of Shariati and Gharzi medical centers in Isfahan. All forms of medicine used are labeled the same and only labeled by the consulting pharmacist. First, the necessary explanations on how to implement the plan are provided to the parents, and then the informed consent form is completed and signed by the child's legal guardian. The personal details of the children participating in the project will be confidential. The required information will be collected by asking the parents and recorded in the relevant questionnaire. The forms are filled in anonymously and in coded form and the treating physician does not witness this process. 3 Functional Constipation. Intervention 1: Intervention group: The first group is dissolved Kidi Lactate probiotic powder in a dose of 1 sachet per day in water and 1 g / kg body weight of water-soluble polyethylene glycol powder is given daily for 2 weeks. At first, it is recommended to consume less food. High fat and dairy and recommend eating more fruits, vegetables and high fiber foods. Parents are also given the necessary training on using the toilet and encouraging their children to go to the toilet, and it is recommended that they exercise regularly and use the toilet after each meal. Intervention 2: Control group: 1 g / kg body weight of water-soluble polyethylene glycol powder is given daily for 2 weeks. Parents are also instructed in using the toilet and encouraging their children to go to the toilet, and it is recommended that they exercise regularly and use the toilet after each meal. 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 There is no more information.
public Pegah Kaveh
No. 5, Azar 17 Alley, Panje Azar St, Jaber Ansari Ave
Isfahan Iran (Islamic Republic of) 8138958638 +98 31 3433 1295 pgh.kaveh@gmail.com Islamic Azad University scientific Pegah Kaveh
No. 5, Azar 17 Alley, Panje Azar St, Jaberansari Ave
Isfahan Iran (Islamic Republic of) 8138958638 +98 31 3433 1295 pgh.kaveh@gmail.com Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) Children with functional constipation Between 2 to 15 years old 2 years 15 years Both Diseases of the large and small intestine Sensitivity to polyethylene glycol Intestinal obstruction Kidney or heart failure K59.0 Constipation Treatment - Drugs Treatment - Drugs Intervention group: The first group is dissolved Kidi Lactate probiotic powder in a dose of 1 sachet per day in water and 1 g / kg body weight of water-soluble polyethylene glycol powder is given daily for 2 weeks. At first, it is recommended to consume less food. High fat and dairy and recommend eating more fruits, vegetables and high fiber foods. Parents are also given the necessary training on using the toilet and encouraging their children to go to the toilet, and it is recommended that they exercise regularly and use the toilet after each meal. Control group: 1 g / kg body weight of water-soluble polyethylene glycol powder is given daily for 2 weeks. Parents are also instructed in using the toilet and encouraging their children to go to the toilet, and it is recommended that they exercise regularly and use the toilet after each meal. Number of bowel movements during one week. Timepoint: Number of bowel movements during one week at the beginning of the study (before the intervention) and 7 and 14 days after taking probiotics. Method of measurement: The required information is collected by asking the parents and recorded in the prepared questionnaire. Number of unwanted bowel movements during the day. Timepoint: Number of unwanted bowel movements during the day at the beginning of the study (before the intervention) and 7 and 14 days after taking probiotics. Method of measurement: The required information is collected by asking the parents and recorded in the prepared questionnaire. Number of painful bowel movements in a week. Timepoint: Number of painful bowel movements during one week at the beginning of the study (before the intervention) and 7 and 14 days after the start of probiotic use. Method of measurement: The required information is collected by asking the parents and recorded in the prepared questionnaire. The number of times abdominal pain occurs in a week. Timepoint: The frequency of abdominal pain during one week at the beginning of the study (before the intervention) and 7 and 14 days after taking probiotics. Method of measurement: The required information is collected by asking the parents and recorded in the prepared questionnaire. Determination and comparison of fecal consistency. Timepoint: Determination and comparison of fecal consistency at the beginning of the study (before the intervention) and 7 and 14 days after probiotic use. Method of measurement: The required information is collected by asking the parents and recorded in the prepared questionnaire. Islamic Azad University Approved 2020-09-30 Ethics committee of Islamic Azad University - Shahrood Branch No. 5, Azar 17 Alley, Panje Azar St, Jaber Ansari Ave Isfahan Isfehan Iran (Islamic Republic of)