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Effect of synbiotic in cystic fibrosis

Effect of synbiotic supplementation in comparison with placebo on anthropometric indeices, quality of life and clinical outcome in children with cystic fibrosis.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017011732004N1
Enrollment
40
Registered
2017-02-14
Start date
2017-04-04
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. E84.0 Cystic fibrosis with pulmonary manifestations

Interventions

Intervention 1: intervention: 2 synbiotic capsule per day fami lact capsuls from Zist Takhmir factory capsuls include: 10 9 bacteria namely Lactobacilus casei, Lactobacilus Ramnosis, Lactobacilus b
Treatment - Drugs
intervention: 2 synbiotic capsule per day fami lact capsuls from Zist Takhmir factory capsuls include: 10 9 bacteria namely Lactobacilus casei, Lactobacilus Ramnosis, Lactobacilus bolgaricus, str
2 placebo capsules/day including corn starch

Sponsors

Pediatric health research center
Lead Sponsor
Vice Chancellor for research of Tabriz University of Medical Sciences
Collaborator

Eligibility

Sex/Gender
Male
Age
5 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: children with cystic fibrosis; aged between 5-12 years exclusion criteria: having other disease including diabetes; cirrhosis; hypo-albominemia; ventilator dependent respiratory failure

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Anthropocentric measures. Timepoint: before supplementation and every month after supplementation for 6 month. Method of measurement: scale and stadiomete.;Diarehea. Timepoint: Before supplementation and every month after supplementation for 6 month. Method of measurement: Questionnaire.;Quality of life. Timepoint: before supplementation and every month after supplementation for 6 month. Method of measurement: Questionnaire.;Antibiotic treatment (oral and IV therapy). Timepoint: before supplementation and 2, 4 and 6 month after supplemenattion. Method of measurement: Questionnaire.;Hospitalization. Timepoint: before supplementation and every month after supplementation for 6 month. Method of measurement: Questionnaire.

Secondary

MeasureTime frame
Serum total antioxidant. Timepoint: before and after six month of supplementation. Method of measurement: commercial kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr zeinab Niknaiz

Liver and gastrointestinal disease research center

nikniazz@tbzmed.ac.ir+98 41133351688

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 25, 2026