See the published version of this article at BMC Nutrition.
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Research article
Zeinab Nikniaz
Liver and gastrointestinal diseases research center, Tabriz University of medical sciences, Tabriz, Iran
Corresponding Author
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View the published article at BMC Nutrition.
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).
Keywords
quality of life, cystic fibrosis, synbiotic, children
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Editorial decision: Major revision
On 08 Jul, 2020
Review #1 received
Received 21 Jun, 2020
Review #2 received
Received 21 Jun, 2020
Reviewer #3 agreed
On 06 Jun, 2020
Review #3 received
Received 06 Jun, 2020
Reviewer #2 agreed
On 03 Jun, 2020
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Reviewer #1 agreed
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This preprint is under consideration at BMC Nutrition. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Zeinab Nikniaz
Liver and gastrointestinal diseases research center, Tabriz University of medical sciences, Tabriz, Iran
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 4
Posted 20 Aug, 2020
Published
On 15 Oct, 2020
No community comments so far
Editorial decision: Accept
On 19 Aug, 2020
Editor assigned
On 17 Aug, 2020
Submission checks complete
On 16 Aug, 2020
Editor invited
On 16 Aug, 2020
No comments provided
Reviewers invited
Invitations sent on 12 Aug, 2020
Editorial decision: Minor revision
On 12 Aug, 2020
Editor assigned
On 02 Aug, 2020
Submission checks complete
On 01 Aug, 2020
Editor invited
On 01 Aug, 2020
No comments provided
Editorial decision: Minor revision
On 29 Jul, 2020
Review #1 received
Received 27 Jul, 2020
Reviewer #1 agreed
On 26 Jul, 2020
Reviewers invited
Invitations sent on 23 Jul, 2020
Editor assigned
On 13 Jul, 2020
Submission checks complete
On 12 Jul, 2020
Editor invited
On 12 Jul, 2020
No comments provided
Editorial decision: Major revision
On 08 Jul, 2020
Review #1 received
Received 21 Jun, 2020
Review #2 received
Received 21 Jun, 2020
Reviewer #3 agreed
On 06 Jun, 2020
Review #3 received
Received 06 Jun, 2020
Reviewer #2 agreed
On 03 Jun, 2020
Reviewers invited
Invitations sent on 02 Jun, 2020
Reviewer #1 agreed
On 02 Jun, 2020
Editor assigned
On 05 May, 2020
First submitted
On 04 May, 2020
Submission checks complete
On 04 May, 2020
Editor invited
On 04 May, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Nutrition & Dietetics
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Nutrition.
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).
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