Cystic fibrosis in children aged 6 to 13 years. Cystic fibrosis
Conditions
Interventions
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 reute
Sponsors
Semnan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
6 Years to 13 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Mehri Ayati
Semnan University of Medical Sciences
Outcome results
None listed