Does Synbiotic Supplementation Affect the Quality of Life in Children with Cystic Fibrosis? A Pilot Randomized Controlled Clinical Trial

Overview

Journal BMC Nutr

Publisher Biomed Central

Specialty Nutritional Sciences

Date 2020 Oct 19

PMID 33072395

Citations 2

Authors

Nemat Bilan

Effat Marefat

Leila Nikniaz

Mahdieh Abbasalizad Farhangi

Zeinab Nikniaz

Affiliations

Soon will be listed here.

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 6 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 ( > 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).

Citing Articles

Can Bioactive Food Substances Contribute to Cystic Fibrosis-Related Cardiovascular Disease Prevention?.

Trandafir L, Frasinariu O, Tarca E, Butnariu L, Leon Constantin M, Moscalu M Nutrients. 2023; 15(2).

PMID: 36678185 PMC: 9860597. DOI: 10.3390/nu15020314.

The Gut-Lung Axis in Cystic Fibrosis.

Price C, OToole G J Bacteriol. 2021; 203(20):e0031121.

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References

Dorsey J, Gonska T . Bacterial overgrowth, dysbiosis, inflammation, and dysmotility in the Cystic Fibrosis intestine. J Cyst Fibros. 2017; 16 Suppl 2:S14-S23. DOI: 10.1016/j.jcf.2017.07.014. View

Guandalini S, Magazzu G, Chiaro A, La Balestra V, Di Nardo G, Gopalan S . VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study. J Pediatr Gastroenterol Nutr. 2010; 51(1):24-30. DOI: 10.1097/MPG.0b013e3181ca4d95. View

Markowiak P, Slizewska K . The role of probiotics, prebiotics and synbiotics in animal nutrition. Gut Pathog. 2018; 10:21. PMC: 5989473. DOI: 10.1186/s13099-018-0250-0. View

Jafari S, Mehdizadeh-Hakkak A, Kianifar H, Hebrani P, Ahanchian H, Abbasnejad E . Effects of probiotics on quality of life in children with cystic fibrosis; a randomized controlled trial. Iran J Pediatr. 2014; 23(6):669-74. PMC: 4025125. View

Markowiak P, Slizewska K . Effects of Probiotics, Prebiotics, and Synbiotics on Human Health. Nutrients. 2017; 9(9). PMC: 5622781. DOI: 10.3390/nu9091021. View

Bruzzese E, Raia V, Gaudiello G, Polito G, Buccigrossi V, Formicola V . Intestinal inflammation is a frequent feature of cystic fibrosis and is reduced by probiotic administration. Aliment Pharmacol Ther. 2004; 20(7):813-9. DOI: 10.1111/j.1365-2036.2004.02174.x. View

Amiri P, Eslamian G, Mirmiran P, Shiva N, Jafarabadi M, Azizi F . Validity and reliability of the Iranian version of the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™) Generic Core Scales in children. Health Qual Life Outcomes. 2012; 10:3. PMC: 3311062. DOI: 10.1186/1477-7525-10-3. View

Duytschaever G, Huys G, Bekaert M, Boulanger L, De Boeck K, Vandamme P . Cross-sectional and longitudinal comparisons of the predominant fecal microbiota compositions of a group of pediatric patients with cystic fibrosis and their healthy siblings. Appl Environ Microbiol. 2011; 77(22):8015-24. PMC: 3208981. DOI: 10.1128/AEM.05933-11. View

Varni J, Burwinkle T, Seid M, Skarr D . The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr. 2003; 3(6):329-41. DOI: 10.1367/1539-4409(2003)003<0329:tpaapp>2.0.co;2. View

10.

Bruzzese E, Raia V, Spagnuolo M, Volpicelli M, De Marco G, Maiuri L . Effect of Lactobacillus GG supplementation on pulmonary exacerbations in patients with cystic fibrosis: a pilot study. Clin Nutr. 2007; 26(3):322-8. DOI: 10.1016/j.clnu.2007.01.004. View

11.

Rowland M, Gallagher C, Gallagher C, Laoide R, Canny G, Marie Broderick A . Outcome in patients with cystic fibrosis liver disease. J Cyst Fibros. 2014; 14(1):120-6. DOI: 10.1016/j.jcf.2014.05.013. View

12.

Infante Pina D, Redecillas Ferreiro S, Torrent Vernetta A, Segarra Canton O, Maldonado Smith M, Gartner Tizziano L . [Improvement of intestinal function in cystic fibrosis patients using probiotics]. An Pediatr (Barc). 2009; 69(6):501-5. DOI: 10.1016/s1695-4033(08)75231-7. View

13.

Del Campo R, Garriga M, Perez-Aragon A, Guallarte P, Lamas A, Maiz L . Improvement of digestive health and reduction in proteobacterial populations in the gut microbiota of cystic fibrosis patients using a Lactobacillus reuteri probiotic preparation: a double blind prospective study. J Cyst Fibros. 2014; 13(6):716-22. DOI: 10.1016/j.jcf.2014.02.007. View

14.

Nikniaz Z, Nikniaz L, Bilan N, Somi M, Faramarzi E . Does probiotic supplementation affect pulmonary exacerbation and intestinal inflammation in cystic fibrosis: a systematic review of randomized clinical trials. World J Pediatr. 2017; 13(4):307-313. DOI: 10.1007/s12519-017-0033-6. View

15.

Duytschaever G, Huys G, Bekaert M, Boulanger L, De Boeck K, Vandamme P . Dysbiosis of bifidobacteria and Clostridium cluster XIVa in the cystic fibrosis fecal microbiota. J Cyst Fibros. 2012; 12(3):206-15. DOI: 10.1016/j.jcf.2012.10.003. View

16.

Huang C, Chie W, Wang I . Efficacy of Administration in School-Age Children with Asthma: A Randomized, Placebo-Controlled Trial. Nutrients. 2018; 10(11). PMC: 6265750. DOI: 10.3390/nu10111678. View