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IRCT20251004067497N1 IRCT 2025-10-08 Semnan University of Medical Sciences The Effect of Probiotics in Children with Cystic Fibrosis The Effect of Probiotic Consumption on Improving the Quality of Life in Children Aged 6 to 13 Years with Cystic Fibrosis (CF) 2025-10-18 anticipated 110 Complete https://irct.ir/trial/86573 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization Method: Block Randomization (Randomization Block Method) In this method, participants are divided into blocks of four, and the order of assignment to the probiotic or placebo groups is determined randomly. This method ensures that the number of participants in each group is equal at the end of each block, maintaining balance between the groups. Unit of Randomization: Individual Randomization Each participant is independently and randomly assigned to one of the two groups (probiotic or placebo). Stratification: on similar age groups to maintain age homogeneity between the groups. Randomization Tool: Randomization List Generation of Random Sequence: The order of group assignments within each block of four participants was determined randomly. Allocation Concealment: The study was conducted as a double-blind trial (Double-blind), Blinding description: Participants were blinded to their assigned group (probiotic or placebo), and the sachets were coded and packaged by an independent person. The principal investigators did not have access to the actual content of the sachets to minimize bias in the conduct of the study and data collection. Outcome assessors and data analysts worked with coded data and were unaware of the actual group assignments. The independent person responsible for coding was not blinded and was in charge of preparing and labeling the sachets. The manuscript was prepared after data collection was completed and the codes were unblinded, and the person responsible had access to the actual group assignments; therefore, they were not blinded. 3 Cystic fibrosis in children aged 6 to 13 years. Intervention 1: Intervention group: Children with cystic fibrosis (CF), aged 6 to 13 years, who will consume daily, for a period of two months, one sachet of a probiotic containing Lactobacillus reuteri (commercial name: Rutfloor), manufactured by Farabiotic Company, at a dose of 1X10⁸ CFU/day. Intervention 2: Control group: Children with CF in the same age range who will consume, daily for two months, a placebo sachet containing maltodextrin and 1% magnesium stearate, and free of any live bacteria, manufactured by Farabiotic Company. 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 Dr.Mehri Ayati
Amir al-Momenin (AS) Educational, Research & Treatment Center, No. 9771, Shahid Mostafa Khomeini Blvd., Imam Hossein Square, Semnan County, Semnan Province, Iran
Semnan Iran (Islamic Republic of) 34731-35197 +98 23 3346 0055 amir.hospital@semums.ac.ir Semnan University of Medical Sciences scientific Dr.Mehri Ayati
Amir al-Momenin (AS) Educational, Research & Treatment Center, No. 9771, Shahid Mostafa Khomeini Blvd., Imam Hossein Square, Semnan County, Semnan Province, Iran
Semnan Iran (Islamic Republic of) 34731-35197 +98 23 3346 0055 amir.hospital@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Definitive diagnosis of cystic fibrosis (CF): The child or adolescent must have a CF diagnosis confirmed by a specialist physician, with medical documentation including pancreatic insufficiency and fecal elastase less than 200 μg/g Age between 6 and 13 years: Patients must fall within the study’s age range to allow assessment of growth and physical functioning. Stable clinical condition: The child must be in a stable clinical state and must not have had an acute infection or hospitalization in the 4 weeks prior to the start of the study Ability to participate in the study and complete questionnaires: The patient or parents must be able to accurately respond to questionnaires regarding quality of life, respiratory, and gastrointestinal symptoms. Informed consent from parents or legal guardians: Participation in the study is only possible with written consent from the parents or legal guardian. No use of similar probiotics in the past month: Patients must not have used other probiotic supplements in the 4 weeks prior to the study to ensure the effect of the study probiotic is accurately assessed. 6 years 13 years Both Allergy or intolerance to probiotics: Patients who are allergic to Lactobacillus reuteri or other components of the supplement, or who experience severe adverse effects from probiotic consumption, will be excluded from the study Severe chronic or underlying diseases unrelated to CF: Children who, in addition to CF, have severe chronic conditions (e.g., advanced heart, liver, or kidney failure) that could affect weight, appetite, or quality of life. Concurrent autoimmune diseases such as celiac disease or immunodeficiency disorders are also considered exclusion criteria Concurrent use of other probiotics or supplements: Patients who use other probiotics, similar nutritional supplements, or medications that directly affect gastrointestinal or respiratory symptoms of CF during the study. Incomplete questionnaires or lack of follow-up: Children who do not complete the questionnaires fully or fail to participate in regular follow-ups over the two-month study period. Acute infections or hospitalization during the study: Patients who are hospitalized or receive new inpatient treatments due to severe infections, as this could confound the effects of the probiotic. E84 Cystic fibrosis Treatment - Drugs Treatment - Drugs Intervention group: Children with cystic fibrosis (CF), aged 6 to 13 years, who will consume daily, for a period of two months, one sachet of a probiotic containing Lactobacillus reuteri (commercial name: Rutfloor), manufactured by Farabiotic Company, at a dose of 1X10⁸ CFU/day. Control group: Children with CF in the same age range who will consume, daily for two months, a placebo sachet containing maltodextrin and 1% magnesium stearate, and free of any live bacteria, manufactured by Farabiotic Company. Change in total quality of life score of patients with cystic fibrosis (CF) after two months of probiotic (Lactobacillus reuteri) consumption compared with placebo, based on the standardized Cystic Fibrosis Quality of Life Questionnaire (CF-QoL).This questionnaire assesses multiple domains including physical, psychological, and social aspects, as well as clinical symptoms such as daily activities, mood, appetite, respiratory symptoms (cough and wheezing), and gastrointestinal symptoms (abdominal pain).An increase in the questionnaire score indicates an improvement in the patient’s quality of life. The total score will be compared before and after the intervention. Timepoint: The effect of the probiotic is assessed two months after consumption. Patients’ quality of life is measured before the start of the intervention and two months afterward. Method of measurement: The Cystic Fibrosis Quality of Life Questionnaire (CF-QoL) translated by Talebi. https://ispgh.ir/wp-content/uploads/2023/02/article6.pdf. Semnan University of Medical Sciences Approved 2025-09-22 Ethics committee of Semnan University of Medical Sciences Semnan, Basij Boulevard, Head Office of Semnan University of Medical Sciences and Health Services Semnan Semnan Iran (Islamic Republic of)