Probiotic effect on growth and quality of life in children with Cystic Fibrosis

Evaluation of probiotic effect on growth indicators and quality of life in children with Cystic Fibrosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201205219823N1

Enrollment

Registered

2012-07-25

Start date

2010-06-23

Completion date

Unknown

Last updated

2018-02-22

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: The intervention group: Protexin, 2 Capsules, daily, 1 Month. Intervention 2: The control group: No action.

Treatment - Drugs

The intervention group: Protexin, 2 Capsules, daily, 1 Month

The control group: No action

Eligibility

Sex/Gender

All

Age

2 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Ages 2 to 12 years old; Cystic Fibrosis disease confirmed by sweat testing, clinical symptoms and common mutations. Exclusion criteria: Patient intolerance to the medication; A lack of parental consent; Inability of probiotic consumption because of severe disease.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Number of pulmonary exacerbations. Timepoint: One month after the intervention, three months after the intervention. Method of measurement: Review records of patients.;Quality of Life. Timepoint: Before the intervention, three months after the intervention, six months after intervention. Method of measurement: PedsQL 4.0 questionnaire.;Height. Timepoint: Before the intervention, one month after the intervention, three months after the intervention. Method of measurement: Wall of examination room.;Weight. Timepoint: Before the intervention, one month after the intervention, three months after the intervention. Method of measurement: Standard scale.;Head Circumference. Timepoint: Before the intervention, one month after the intervention, three months after the intervention. Method of measurement: Meter.;Arm Circumference. Timepoint: Before the intervention, one month after the intervention, three months after the intervention. Method of measurement: Meter.	—

Measure

Time frame

Number of pulmonary exacerbations. Timepoint: One month after the intervention, three months after the intervention. Method of measurement: Review records of patients.;Quality of Life. Timepoint: Before the intervention, three months after the intervention, six months after intervention. Method of measurement: PedsQL 4.0 questionnaire.;Height. Timepoint: Before the intervention, one month after the intervention, three months after the intervention. Method of measurement: Wall of examination room.;Weight. Timepoint: Before the intervention, one month after the intervention, three months after the intervention. Method of measurement: Standard scale.;Head Circumference. Timepoint: Before the intervention, one month after the intervention, three months after the intervention. Method of measurement: Meter.;Arm Circumference. Timepoint: Before the intervention, one month after the intervention, three months after the intervention. Method of measurement: Meter.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hamidreza Kianifar

Ghaem Hospital

kianifarhr@mums.ac.ir+98 51 1840 0001

Outcome results

None listed

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