Protocol summary

Study aim
Evaluation of the two-month effect of probiotic consumption on improving the quality of life of children aged 6–13 years with cystic fibrosis
Design
This study is a randomized, double-blind, parallel-group, phase 3 clinical trial conducted on 110 participants. Randomization was performed using the RAND function in Microsoft Excel.
Settings and conduct
a randomized double-blind clinical trial conducted at the CF Clinic of Tehran Children’s Medical Center and Amir al-Momenin Hospital in Semnan. A total of 110 children aged 6–13 will be randomly assigned to two groups: the intervention group and control group. Quality of life will be measured using the CF-QoL questionnaire. participants and researchers will be blinded to group allocation
Participants/Inclusion and exclusion criteria
Inclusion Criteria:1)Definitive diagnosis of cystic fibrosis .2) Age between 6 and 13 years.3)Stable clinical condition 4) Ability to participate in the study and complete questionnaires.5)Informed consent . 6)No use of similar probiotics in the past month.Exclusion Criteria:1) Allergy or intolerance to probiotics. 2)Severe chronic or underlying diseases unrelated to CF. 3)Concurrent use of other probiotics or supplements. 4)Incomplete questionnaires or failure to attend follow-ups. 5)Acute infections or hospitalization during the study.
Intervention groups
Intervention group: Participants in this group will receive one sachet containing the probiotic Lactobacillus reuteri with a specified dose (1×10⁸ CFU/day) daily for two consecutive months. Control (placebo) group: Participants in this group will also receive one sachet of a placebo daily for two months.
Main outcome variables
Improvement in quality of life will include evaluating the improvement of mood, appetite, weight gain, reduction of cough and wheezing, relief of abdominal pain, and the ability to tolerate daily and physical activities.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251004067497N1
Registration date: 2025-10-08, 1404/07/16
Registration timing: prospective

Last update: 2025-10-08, 1404/07/16
Update count: 0
Registration date
2025-10-08, 1404/07/16
Registrant information
Name
Mehri Ayati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3363 5254
Email address
m.mehraneh77@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-18, 1404/07/26
Expected recruitment end date
2026-03-16, 1404/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Probiotic Consumption on Improving the Quality of Life in Children Aged 6 to 13 Years with Cystic Fibrosis (CF)
Public title
The Effect of Probiotics in Children with Cystic Fibrosis
Purpose
Treatment
Inclusion/Exclusion 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:
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.
Age
From 6 years old to 13 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan, Basij Boulevard, Head Office of Semnan University of Medical Sciences and Health Services
City
Semnan
Province
Semnan
Postal code
99442-35147
Approval date
2025-09-22, 1404/06/31
Ethics committee reference number
IR.SEMUMS.REC.1404.176

Health conditions studied

1

Description of health condition studied
Cystic fibrosis in children aged 6 to 13 years
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis

Primary outcomes

1

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Children's Medical Center Clinic
Full name of responsible person
Dr.Mehri Ayati
Street address
Children's Medical Center, No. 62, next to Imam Khomeini Hospital, Dr. Mohammad Gharib Street, End of Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9999
Email
cmcpr@tums.ac.ir
Web page address
https://chmc.tums.ac.ir/

2

Recruitment center
Name of recruitment center
Amir al-Momenin Hospital Clinic
Full name of responsible person
Dr.Mehri Ayati
Street address
Amir al-Momenin (AS) Educational, Research & Treatment Center, No. 9771, Shahid Mostafa Khomeini Blvd., Imam Hossein Square, Semnan County, Semnan Province, Iran
City
Semnan
Province
Semnan
Postal code
34731-35197
Phone
+98 23 3346 0055
Email
amir.hospital@semums.ac.ir
Web page address
https://amirhos.semums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr.Majid Eslami
Street address
Deputy of Research and Technology, Central Headquarters, Semnan University of Medical Sciences, Basij Boulevard, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Web page address
https://rtvc.semums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr.Mehri Ayati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amir al-Momenin (AS) Educational, Research & Treatment Center, No. 9771, Shahid Mostafa Khomeini Blvd., Imam Hossein Square, Semnan County, Semnan Province, Iran
City
Semnan
Province
Semnan
Postal code
34731-35197
Phone
+98 23 3346 0055
Email
amir.hospital@semums.ac.ir
Web page address
https://amirhos.semums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr.Mehri Ayati
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amir al-Momenin (AS) Educational, Research & Treatment Center, No. 9771, Shahid Mostafa Khomeini Blvd., Imam Hossein Square, Semnan County, Semnan Province, Iran
City
Semnan
Province
Semnan
Postal code
34731-35197
Phone
+98 23 3346 0055
Email
amir.hospital@semums.ac.ir
Web page address
https://amirhos.semums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr.Mehri Ayati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amir al-Momenin (AS) Educational, Research & Treatment Center, No. 9771, Shahid Mostafa Khomeini Blvd., Imam Hossein Square, Semnan County, Semnan Province, Iran
City
Semnan
Province
Semnan
Postal code
34731-35197
Phone
+98 23 3346 0055
Email
amir.hospital@semums.ac.ir
Web page address
https://amirhos.semums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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