comparing the effect of probiotics in cystic fibrosis

comparing the effect of probiotics in improving pulmonary gastrointestinal symptoms with cystic fibrosis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240105060622N1

Enrollment

108

Registered

2024-08-16

Start date

2024-02-20

Completion date

Unknown

Last updated

2024-08-26

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: Patients in the probiotic group will receive Lactobacillus reuteri (Rotflor) at the rate of 10*8 CFU/d for one month. Intervention 2: Control group: Patients receiv

Eligibility

Sex/Gender

All

Age

6 Years to 12 Years

Inclusion criteria

Inclusion criteria: cystic fibrosis patient with an age range of 6 to 12 years Informed consent from parents Having pancreatic insufficiency Fecal elastase less than 200 micrograms per gram

Exclusion criteria

Exclusion criteria: having comorbidity disease except cystic fibrosis contraindication for probitotics

Design outcomes

Primary

Measure	Time frame
Fat stool. Timepoint: Measurement of fat excretion at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Paraclinic - laboratory-stool Exam.;Patient Weight. Timepoint: Measurement of the patient's weight at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: scales.;Quality of life. Timepoint: Measurement of the quality of life at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Questionnaire-Clinical File.;Forced Expiratory Volume in First Second (FEV1). Timepoint: Measurement of the FEV1 at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Spirometry device.;Forced Vital Capacity (FVC). Timepoint: Measurement of the FVC at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Spirometry device.;Throat culture. Timepoint: Measurement of the Throat culture at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Paraclinic - laboratory-Throat culture test.	—

Measure

Time frame

Fat stool. Timepoint: Measurement of fat excretion at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Paraclinic - laboratory-stool Exam.;Patient Weight. Timepoint: Measurement of the patient's weight at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: scales.;Quality of life. Timepoint: Measurement of the quality of life at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Questionnaire-Clinical File.;Forced Expiratory Volume in First Second (FEV1). Timepoint: Measurement of the FEV1 at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Spirometry device.;Forced Vital Capacity (FVC). Timepoint: Measurement of the FVC at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Spirometry device.;Throat culture. Timepoint: Measurement of the Throat culture at the beginning of the study (before the start of the intervention), 30 and 90 days after starting one month of probiotic consumption. Method of measurement: Paraclinic - laboratory-Throat culture test.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehri Ayati

Tehran University of Medical Sciences

dr.m.ayati61@gmail.com+98 21 6147 9000

Outcome results

None listed

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