Effects of synbiotic supplementation on the pulmonary manifestations and anthropometric measurements in children with cystic fibrosis- a randomized clinical trial

2020 ◽  
Vol 33 ◽  
pp. 101027
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Masoud Nouri-Vaskeh ◽  
Leila Nikniaz ◽  
Zeinab Nikniaz
Keyword(s):  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Randomized Clinical Trial ◽  
Anthropometric Measurements ◽  
Pulmonary Manifestations ◽  
Synbiotic Supplementation

scholarly journals Oral cysteamine as an adjunct treatment in cystic fibrosis pulmonary exacerbations: An exploratory randomized clinical trial

PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0242945
Author(s):  
Graham Devereux ◽  
Danielle Wrolstad ◽  
Stephen J. Bourke ◽  
Cori L. Daines ◽  
Simon Doe ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Randomized Clinical Trial ◽  
Outcome Measures ◽  
Leukocyte Count ◽  
Bacterial Load ◽  
Adjunct Treatment ◽  
Dosing Regimens ◽  
Pulmonary Exacerbations ◽  
Blood Leukocyte

Background Emerging data suggests a possible role for cysteamine as an adjunct treatment for pulmonary exacerbations of cystic fibrosis (CF) that continue to be a major clinical challenge. There are no studies investigating the use of cysteamine in pulmonary exacerbations of CF. This exploratory randomized clinical trial was conducted to answer the question: In future pivotal trials of cysteamine as an adjunct treatment in pulmonary exacerbations of CF, which candidate cysteamine dosing regimens should be tested and which are the most appropriate, clinically meaningful outcome measures to employ as endpoints? Methods and findings Multicentre double-blind randomized clinical trial. Adults experiencing a pulmonary exacerbation of CF being treated with standard care that included aminoglycoside therapy were randomized equally to a concomitant 14-day course of placebo, or one of 5 dosing regimens of cysteamine. Outcomes were recorded on days 0, 7, 14 and 21 and included sputum bacterial load and the patient reported outcome measures (PROMs): Chronic Respiratory Infection Symptom Score (CRISS), the Cystic Fibrosis Questionnaire–Revised (CFQ-R); FEV1, blood leukocyte count, and inflammatory markers. Eighty nine participants in fifteen US and EU centres were randomized, 78 completed the 14-day treatment period. Cysteamine had no significant effect on sputum bacterial load, however technical difficulties limited interpretation. The most consistent findings were for cysteamine 450mg twice daily that had effects additional to that observed with placebo, with improved symptoms, CRISS additional 9.85 points (95% CI 0.02, 19.7) p = 0.05, reduced blood leukocyte count by 2.46x109 /l (95% CI 0.11, 4.80), p = 0.041 and reduced CRP by geometric mean 2.57 nmol/l (95% CI 0.15, 0.99), p = 0.049. Conclusion In this exploratory study cysteamine appeared to be safe and well-tolerated. Future pivotal trials investigating the utility of cysteamine in pulmonary exacerbations of CF need to include the cysteamine 450mg doses and CRISS and blood leukocyte count as outcome measures. Clinical trial registration NCT03000348; www.clinicaltrials.gov.

The effects of probiotics and synbiotic supplementation on glucose and insulin metabolism in adults with prediabetes: a double-blind randomized clinical trial

2018 ◽  
Vol 55 (10) ◽  
pp. 1019-1028 ◽  
Author(s):  
Nazila Kassaian ◽  
Awat Feizi ◽  
Ashraf Aminorroaya ◽  
Parvaneh Jafari ◽  
Maryam Tajabadi Ebrahimi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Double Blind ◽  
Insulin Metabolism ◽  
Synbiotic Supplementation

Inhalation Treatment with Glutathione in Patients with Cystic Fibrosis. A Randomized Clinical Trial

2013 ◽  
Vol 188 (1) ◽  
pp. 83-89 ◽  
Author(s):  
Matthias Griese ◽  
Matthias Kappler ◽  
Claudia Eismann ◽  
Manfred Ballmann ◽  
Sibylle Junge ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Randomized Clinical Trial

Associations between vitamin D, systemic inflammation and synbiotic supplementation: secondary study from a randomized clinical trial

Nutrire ◽  
2019 ◽  
Vol 45 (1) ◽  
Author(s):  
Cecilia Maria Resende Gonçalves de Carvalho ◽  
Liania Alves Luzia ◽  
Patricia Helen Rondó ◽  
Sandra Maria Lima Ribeiro
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Randomized Clinical Trial ◽  
Systemic Inflammation ◽  
Synbiotic Supplementation ◽  
Secondary Study

scholarly journals Does synbiotic supplementation affect the quality of life in children with cystic fibrosis? A pilot randomized controlled clinical trial

2020 ◽  
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Leila Nikniaz ◽  
Mahdieh Abbasalizad Farhangi ◽  
Zeinab Nikniaz
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Demographic Data ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract Background: There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF.Methods: In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for six months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis. Results: Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34±17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation (p>0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores. Conclusion: According to results, six-month supplementation with synbiotic did not have a significant effect on the HRQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion. The protocol of the study was registered at Iranian registry clinical trials (Registration code: IRCT2017011732004N1; Registration date: 2017-02-14).

scholarly journals Chest computed tomography outcomes in a randomized clinical trial in cystic fibrosis: Lessons learned from the first ataluren phase 3 study

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0240898
Author(s):  
Harm A. W. M. Tiddens ◽  
Eleni-Rosalina Andrinopoulou ◽  
Joe McIntosh ◽  
J. Stuart Elborn ◽  
Eitan Kerem ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Randomized Clinical Trial ◽  
Lessons Learned ◽  
Phase 3 ◽  
Chest Computed Tomography

scholarly journals Does synbiotic supplementation affect the quality of life in children with cystic fibrosis? A pilot randomized controlled clinical trial

2020 ◽  
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Leila Nikniaz ◽  
Mahdieh Abbasalizad Farhangi ◽  
Zeinab Nikniaz
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Demographic Data ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract Background: There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF.Methods: In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for six months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis. Results: Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34±17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation (p>0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores. Conclusion: According to results, six-month supplementation with synbiotic did not have a significant effect on the HRQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion. The protocol of the study was registered at Iranian registry clinical trials (Registration code: IRCT2017011732004N1; Registration date: 2017-02-14).

Sign in / Sign up

Export Citation Format

Share Document