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IRCT20231004059611N1 IRCT 2024-01-08 Bandare-abbas University of Medical Sciences Probiotics in the Management of Functional Constipation in Children Evaluating the Therapeutic Effectiveness of Probiotics on Pediatric Functional Constipation in a Cohort Aged 2 to 12 Years 2024-01-20 anticipated 170 Complete https://irct.ir/trial/72974 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization Unit: Individual participants. Method: Equal and independent chance of being assigned to either group, without age or characteristic stratification. Tool: Random allocation software for unbiased, random sequence generation. Sequence Generation: Pre-generated random sequence for assigning participants upon enrollment. Allocation Concealment: Hidden sequence from the research team to prevent selection bias. This approach ensures a fair and transparent allocation, maintaining the integrity and reliability of the study, Blinding description: Participants and Caregivers: Unaware of whether receiving probiotics or placebo. Researchers and Principal Investigator: Blind to treatment allocation to prevent bias in study management and interpretation. Healthcare Personnel (Physicians, Nurses, etc.): Not informed of individual treatments to ensure unbiased patient care. Data Collectors and Outcome Assessors: Kept blind to avoid influence on data recording or result interpretation. Data Safety and Monitoring Committee: Not Blinded Treatments, prepared by a third-party manufacturer, are coded and labeled indistinguishably. The manufacturer holds the treatment codes securely, only to be revealed after study completion or in medical emergencies. Participants are fully informed about their trial participation, but specific treatment details are withheld per double-blind study design, ensuring ethical conduct and study validity. 3 Functional Constipation. Intervention 1: Intervention group: Reuteflor oral sachet, each Reuteflor sachet contains 800 million active lyophilized cells of Lactobacillus roteri (equivalent to 8*10^8 CFU), 1 to 2 sachets per day or according to the doctor's opinion, for use in children over two years of age and adolescents. and adults, the duration of use is 28 days, dissolve the contents of one sachet in a quantity of liquid or solid food compounds that are allowed by a doctor or pharmacist, such as water, yogurt or (cold) food and immediately Consume up to thirty minutes before. Make sure that the content of the sachet is well dissolved in the liquid, yogurt or food before consumption. Manufacturer: Faradaro Fan Avar Mehr Company (Farabiotic). Intervention 2: Control group: Receiving placebo, dosage, number of times of use, duration of use, method of use as in the intervention group. Manufacturer: Faradaro Fan Avar Mehr Company (Farabiotic). Yes - There is a plan to make this available What will be shared: Investigative Elements Comprising Individual Participant Data (IPD), Study Protocol, Statistical Analysis Blueprint, Informed Consent Documentation, Clinical Study Report, Analytical Coding Framework, and Data Categorization System. A portion of this data, specifically pertaining to the principal outcome, will be designated for scholarly sharing. When: Availability Period Commencing Approximately Six Months Subsequent to the Dissemination of the Final Published Article To whom: Investigators Affiliated with Academic and Scientific Institutions Conditions: For the Purpose of Evaluating the Data Analysis Methodology, Execution of the Plan Utilizing Diverse Data Sets, Sampling Techniques, Randomization Processes, and Data Stratification, Alongside Assessment of the Exclusion Criteria for Disqualified Participants. Where to obtain: Electronic Mail Contact Information of the Principal Project Coordinator: samirashahvari@gmail.com Bandar Abbas Children's Hospital and Hormozgan University of Medical Sciences How to obtain: Full Name and Surname Contact Information: Including Email Address and Mobile Number (where applicable) Academic Qualifications: Degree(s) Held Current Occupational Title and Position Field of Specialization: Specific Academic and Professional Focus Affiliated Organization: Name of the Institution or Entity Intended Purpose for Data Utilization Proposed Methodology for Data Interaction and Analysis Comments:
public Samira Zakeri Shahvari
Emam khomeyni Blvd, Daroupakhsh St.
Bandar Abbas Iran (Islamic Republic of) 7915873665 +98 76 3366 7200 samirashahvari@gmail.com Bandare-abbas University of Medical Sciences scientific Samira Zakeri Shahvari
Emam khomeyni Blvd, Daroupakhsh St.
Bandar Abbas Iran (Islamic Republic of) 7915873665 +98 76 3366 7200 samirashahvari@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Children aged 2 to 12 years Having functional constipation based on Rome criteria 4 Not using probiotics, prebiotics or antibiotics 4 weeks before the start of the research No history of gastrointestinal surgery Lack of sensitivity or tolerance to Lactobacillus roteri (Reuteflor) Interest in participating in the study and consent of family/guardian 2 years 12 years Both Children with organic digestive disorders or any other underlying disease that can affect bowel function. Children with mental disability Current use of medications that affect bowel function such as laxatives or antidiarrheals History of using probiotics, prebiotics or antibiotics 4 weeks before the start of the research Inability or unwillingness to comply with the study protocol or follow-up History of participating in a different clinical trial in the last 3 months K59.0 Constipation Treatment - Drugs Placebo Intervention group: Reuteflor oral sachet, each Reuteflor sachet contains 800 million active lyophilized cells of Lactobacillus roteri (equivalent to 8*10^8 CFU), 1 to 2 sachets per day or according to the doctor's opinion, for use in children over two years of age and adolescents. and adults, the duration of use is 28 days, dissolve the contents of one sachet in a quantity of liquid or solid food compounds that are allowed by a doctor or pharmacist, such as water, yogurt or (cold) food and immediately Consume up to thirty minutes before. Make sure that the content of the sachet is well dissolved in the liquid, yogurt or food before consumption. Manufacturer: Faradaro Fan Avar Mehr Company (Farabiotic) Control group: Receiving placebo, dosage, number of times of use, duration of use, method of use as in the intervention group. Manufacturer: Faradaro Fan Avar Mehr Company (Farabiotic) Functional Constipation based on ROME IV Criteria. Timepoint: Initial Presentation and Subsequent Observations on Days 7, 14, 21, and 28, as well as Two Months Post-Administration of Probiotics. Method of measurement: ROME IV Criteria. Bandare-abbas University of Medical Sciences Approved 2023-08-04 Ethics committee of Hormozgan University of Medical Sciences Chamran Blvd Bandar Abbas Hormozgan Iran (Islamic Republic of)