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IRCT20160117026069N5 IRCT 2023-01-26 Karaj University of Medical Sciences Evaluation of probiotic use in chronic functional constipation Evaluation of probiotic use (Lactobacillus reuteri) in children between ages of 2 and 14 with chronic functional constipation; Double-blind randomized clinical trial. 2023-01-21 anticipated 60 Complete https://irct.ir/trial/67788 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sealed envelopes are considered as the number of patients, whose content determines which group each person belongs to. One of these envelopes is selected for each patient by lottery, and then this envelope is opened and the allocation of the patient will be determined after opening the envelopes, Blinding description: Only the main researcher of the research is aware of the assignment of the codes, and until the end of the research, it will not be clear for the patient, the treating physician and those who evaluate the results, whether A or B is a placebo or the studied probiotic combination. 3 Functional constipation. Intervention 1: Pidrolax drug (Pidrolax 4000 powder, 70g packets, made by Sepidaj Daru Company) is prescribed according to the following method: Children's dose 2 to 6 years old: 5 grams (one tablespoon) dissolved in a quarter of a glass of water or fruit juice and preferably eaten in the morning on an empty stomach. Children from 7 to 14 years old: 10 grams (one tablespoon) dissolved in half a glass of water or fruit juice and preferably eaten in the morning on an empty stomach. The patient should be repeated, and then in the following days, according to the patient's response status, the drug dose should be adjusted so that he has at least one soft stool per day. In case of no response despite taking the maximum dose of Pidrolox, the situation should be reported to the project manager. To take the necessary measures to correct the treatment. The main drug under investigation is the probiotic Lactobacillus roteri (Roteflor powder, produced by Farabiotic Company) in the form of one-gram sachets containing 300 mg of lyophilized active cells (equivalent to 8x10⁸ CFU), which according to the doctor's prescription, one sachet per day in half a glass of cold liquid or yogurt It is solved and consumed. In the first session, complete explanations about the treatment process, how to take medicines, diet, necessary behavioral training and danger signs are given to the parents, and the patient's information and history are recorded. After the start of the treatment, in the weeks 1st, 3rd, 5th and 7th, during a phone call or in person (according to the discretion of the patient's parents), the patient's condition is measured and the course of the symptoms is recorded, and the necessary corrections are applied in the way of implementing the treatment or any side issues that arise. The treatment is carried out for 7 weeks, and the parents are advised to avoid stopping or changing the medication without coordinating with the doctor. If the child has not had a stool for three consecutive days, life-saving treatment with liquid paraffin medicine with a dose of 1-3 cc /kg will be used. Intervention 2: Pidrolax drug (Pidrolax 4000 powder, 70g packets, made by Sepidaj Daru Company) is prescribed according to the following method: Children's dose 2 to 6 years old: 5 grams (one tablespoon) dissolved in a quarter of a glass of water or fruit juice and preferably eaten in the morning on an empty stomach. Children from 7 to 14 years old: 10 grams (one tablespoon) dissolved in half a glass of water or fruit juice and preferably eaten in the morning on an empty stomach. The patient should be repeated, and then in the following days, according to the patient's response status, the drug dose should be adjusted so that he has at least one soft stool per day. In case of no response despite taking the maximum dose of Pidrolox, the situation should be reported to the project manager. To take the necessary measures to correct the treatment. The control group will receive placebo which is similar to the main drug, a powder produced by Farabiotic Company in the form of one-gram sachets which according to the doctor's prescription, one sachet per day in half a glass of cold liquid or yogurt It is solved and consumed. In the first session, complete explanations about the treatment process, how to take medicines, diet, necessary behavioral training and danger signs are given to the parents, and the patient's information and history are recorded. After the start of the treatment, in the weeks 1st, 3rd, 5th and 7th, during a phone call or in person (according to the discretion of the patient's parents), the patient's condition is measured and the course of the symptoms is recorded, and the necessary corrections are applied in the way of implementing the treatment or any side issues that arise. The treatment is carried out for 7 weeks, and the parents are advised to avoid stopping or changing the medication without coordinating with the doctor. If the child has not had a stool for three consecutive days, life-saving treatment with liquid paraffin medicine with a dose of 1-3 cc /kg will be used. Yes - There is a plan to make this available What will be shared: All of the participans' individual data When: Access starts 6 months after results are published To whom: All researchers working in academic and scientific institutions and people working in the industry Conditions: If a request with this theme is received, a decision will be made with the opinion of the research team. Where to obtain: To the project manager, Dr. Kyomarth Pourrostami How to obtain: After submitting the request to the project manager, this request will be reviewed by a committee with the presence of all the people involved in the project, and then if the committee gives a positive answer, the data will be provided to the applicant. Comments:
public Fereshteh Ansari
Shahid Beheshti Ave., Hesarak
Karaj Iran (Islamic Republic of) 3197619751 +98 26 3405 0400 fereshtehansari66@gmail.com Razi Vaccine and Serum Research Institute scientific Kumars Pourrostami
Faculty of Medicine, West end of Bu-Ali, Nobovat Sq.
Karaj Iran (Islamic Republic of) 3149969415 +98 26 3447 8835 dr.porrostami1975@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Suffering from functional constipation according to Rome IV criteria Age 2 to 14 years Enforceability of orders by the child's parents 2 years 14 years Both Children with organic causes of constipation including celiac disease, intestinal obstruction, hypothyroidism, anorectal malformation, CF Serious chronic health problems that affect the child's ability to participate in the study, such as metabolic, heart, kidney, and liver diseases Unwanted weight loss equal to or more than 5% of the current weight during the last three months Gastrointestinal bleeding Recurrent or unexplained fever History of abdominal surgery including gastrointestinal surgery, except for appendix removal or hernia repair Simultaneous use of drugs that affect the movements of the digestive system History of increased sensitivity or allergy to experimental drugs Diagnosis of autism symptoms Severe mental problems such as bipolar disorder, schizophrenia, and severe depression Use of (SNS) or antegrade enemas during cecostomy or appendicostomy Treatment - Drugs Placebo Pidrolax drug (Pidrolax 4000 powder, 70g packets, made by Sepidaj Daru Company) is prescribed according to the following method: Children's dose 2 to 6 years old: 5 grams (one tablespoon) dissolved in a quarter of a glass of water or fruit juice and preferably eaten in the morning on an empty stomach. Children from 7 to 14 years old: 10 grams (one tablespoon) dissolved in half a glass of water or fruit juice and preferably eaten in the morning on an empty stomach. The patient should be repeated, and then in the following days, according to the patient's response status, the drug dose should be adjusted so that he has at least one soft stool per day. In case of no response despite taking the maximum dose of Pidrolox, the situation should be reported to the project manager. To take the necessary measures to correct the treatment. The main drug under investigation is the probiotic Lactobacillus roteri (Roteflor powder, produced by Farabiotic Company) in the form of one-gram sachets containing 300 mg of lyophilized active cells (equivalent to 8x10⁸ CFU), which according to the doctor's prescription, one sachet per day in half a glass of cold liquid or yogurt It is solved and consumed. In the first session, complete explanations about the treatment process, how to take medicines, diet, necessary behavioral training and danger signs are given to the parents, and the patient's information and history are recorded. After the start of the treatment, in the weeks 1st, 3rd, 5th and 7th, during a phone call or in person (according to the discretion of the patient's parents), the patient's condition is measured and the course of the symptoms is recorded, and the necessary corrections are applied in the way of implementing the treatment or any side issues that arise. The treatment is carried out for 7 weeks, and the parents are advised to avoid stopping or changing the medication without coordinating with the doctor. If the child has not had a stool for three consecutive days, life-saving treatment with liquid paraffin medicine with a dose of 1-3 cc /kg will be used. Pidrolax drug (Pidrolax 4000 powder, 70g packets, made by Sepidaj Daru Company) is prescribed according to the following method: Children's dose 2 to 6 years old: 5 grams (one tablespoon) dissolved in a quarter of a glass of water or fruit juice and preferably eaten in the morning on an empty stomach. Children from 7 to 14 years old: 10 grams (one tablespoon) dissolved in half a glass of water or fruit juice and preferably eaten in the morning on an empty stomach. The patient should be repeated, and then in the following days, according to the patient's response status, the drug dose should be adjusted so that he has at least one soft stool per day. In case of no response despite taking the maximum dose of Pidrolox, the situation should be reported to the project manager. To take the necessary measures to correct the treatment. The control group will receive placebo which is similar to the main drug, a powder produced by Farabiotic Company in the form of one-gram sachets which according to the doctor's prescription, one sachet per day in half a glass of cold liquid or yogurt It is solved and consumed. In the first session, complete explanations about the treatment process, how to take medicines, diet, necessary behavioral training and danger signs are given to the parents, and the patient's information and history are recorded. After the start of the treatment, in the weeks 1st, 3rd, 5th and 7th, during a phone call or in person (according to the discretion of the patient's parents), the patient's condition is measured and the course of the symptoms is recorded, and the necessary corrections are applied in the way of implementing the treatment or any side issues that arise. The treatment is carried out for 7 weeks, and the parents are advised to avoid stopping or changing the medication without coordinating with the doctor. If the child has not had a stool for three consecutive days, life-saving treatment with liquid paraffin medicine with a dose of 1-3 cc /kg will be used. Treatment of functional constipation. Timepoint: The beginning of the study (before the start of the intervention), one week later, week 3, week 5, and week 7. Method of measurement: doctor checkup. Abdominal pain. Timepoint: The beginning of the study (before the start of the intervention), one week later, week 3, week 5, and week 7. Method of measurement: doctor checkup. Side effects. Timepoint: The beginning of the study (before the start of the intervention), one week later, week 3, week 5, and week 7. Method of measurement: doctor checkup. Need for rescue treatment. Timepoint: The beginning of the study (before the start of the intervention), one week later, week 3, week 5, and week 7. Method of measurement: doctor checkup. Karaj University of Medical Sciences Approved 2022-11-12 Ethics committee of Alborz University of Medical Sciences Saffarian Alley, Golshahr Blvd, Karaj Karaj Alborz Iran (Islamic Republic of)