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The effect of probiotics on CF

The effect of Lactobacillus Reuteri on pulmonary function in Cystic Fibrosis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181020041387N1
Enrollment
40
Registered
2022-11-01
Start date
2021-10-17
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis. Cystic fibrosis

Interventions

Intervention 1: Intervention group: Receiving standard treatment for cystic fibrosis plus one Lactobacilus reuterri sachet daily for 4 months. Intervention 2: Control group: Receiving standard treatm

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 20 Years

Inclusion criteria

Inclusion criteria: Patients who have been diagnosed with CF based on clinical signs and sweat Chloride test. No pulmonary exacerbation two weeks prior the study. Ability to perform spirometry test. The informed willingness to participate in the study. Presence of no other chronic disorder except complications related to CF Six to Twenty years old patients with Cystic Fibrosis disease. The Forced Expiratory Volume in 1 second (FEV1) greater than 40%. Stable clinical condition and no acute upper and lower respiratory infection.

Exclusion criteria

Exclusion criteria: Diagnosed as CF less than 6 months. New complication of CF during the past 3 months. No routine follow up. Disability to perform and repeat spirometry test according to American Thoracic Society criteria

Design outcomes

Primary

MeasureTime frame
Pulmonary exacerbation frequency. Timepoint: During study period (4 months). Method of measurement: Observing symptoms of exacerbation in follow-up visits or patient statements.;Hospitalization frequency. Timepoint: During study period (4 months). Method of measurement: Patient statements.;Weight Z-score. Timepoint: At baseline and at the end of study. Method of measurement: Scale.;Height Z-score. Timepoint: At baseline and at the end of study. Method of measurement: Meter.;BMI Z-score. Timepoint: At baseline and at the end of study. Method of measurement: Weight(kg)/ Height(m)2.;FEV1 Forced Expiratory Volume in First Second. Timepoint: At baseline and at the end of study. Method of measurement: Spirometry.;FEF25-75 Exhale middle airflow. Timepoint: At baseline and at the end of study. Method of measurement: Spirometry.;FEV1/FVC proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full, forced vital capacity. Timepoint: At baseline and at the end of study. Method of measurement: Spirometry.;Forced Vital Capacity (FVC). Timepoint: At baseline and at the end of study. Method of measurement: Spirometry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyedeh Zalfa Modaresi

Shahid Beheshti University of Medical Sciences

dr.modarres@gmail.com+98 21 2222 7021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026