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Effect of Lactocare® Synbiotic on Disease Severity in Ulcerative Colitis: A Randomized Placebo-Controlled Double-Blind Clinical Trial

BACKGROUND Inflammatory bowel diseases are managed by different methods, which may not be well tolerated because of their side effects. Recently, pro-prebiotics are considered as a supplementary treatment in gastrointestinal diseases. In this study, the effect of Lactocare® (ZistTakhmir Company) was...

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Autores principales: Amiriani, Taghi, Rajabli, Niloofar, Faghani, Maryam, Besharat, Sima, Roshandel, Gholamreza, Akhavan Tabib, Atefeh, Joshaghani, Hamidreza
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Iranian Association of Gastroerterology and Hepatology 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7023645/
https://www.ncbi.nlm.nih.gov/pubmed/32082518
http://dx.doi.org/10.15171/mejdd.2020.160
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author Amiriani, Taghi
Rajabli, Niloofar
Faghani, Maryam
Besharat, Sima
Roshandel, Gholamreza
Akhavan Tabib, Atefeh
Joshaghani, Hamidreza
author_facet Amiriani, Taghi
Rajabli, Niloofar
Faghani, Maryam
Besharat, Sima
Roshandel, Gholamreza
Akhavan Tabib, Atefeh
Joshaghani, Hamidreza
author_sort Amiriani, Taghi
collection PubMed
description BACKGROUND Inflammatory bowel diseases are managed by different methods, which may not be well tolerated because of their side effects. Recently, pro-prebiotics are considered as a supplementary treatment in gastrointestinal diseases. In this study, the effect of Lactocare® (ZistTakhmir Company) was investigated on the disease severity in mild to moderate ulcerative colitis. METHODS In this randomized, double-blind clinical trial (Iranian Registry of Clinical Trials number: IRCT201407271264N5), 60 patients with mild to moderate ulcerative colitis were included. An 8-week trial was carried out comparing Lactocare® as a supplement with standard therapy against placebo. Simple Clinical Colitis Activity Index (SCCAI) was measured at baseline and after 8 weeks. Statistical analysis was performed using paired ttest to assess the temporal changes (before and after the treatment) in the mean of SCCAI in each group. Chi-square test was used to compare the response rates. Odds ratios (OR) and the 95% confidence intervals (95%CI) were also calculated. p values of less than 0.05 were considered significant. RESULTS A significant decreased mean SCCAI was seen in the intervention group (4.56 ± 2.56) vs. placebo group (6.54 ± 2.47) (p < 0.05). Response to treatment was seen in 64.3% of the treatment group vs. 47% in the placebo group (p = 0.18). Response to treatment was observed in 90.9% of patients with ulcerative colitis for more than 5 years compared with 44.4% of the control group (p = 0.01). CONCLUSION Regarding the effectiveness of pre-probiotics in mitigating symptoms in patients with ulcerative colitis, it could be suggested to try pre-probiotics in the standard treatment particularly in those with more than five years ofthe disease.
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spelling pubmed-70236452020-02-20 Effect of Lactocare® Synbiotic on Disease Severity in Ulcerative Colitis: A Randomized Placebo-Controlled Double-Blind Clinical Trial Amiriani, Taghi Rajabli, Niloofar Faghani, Maryam Besharat, Sima Roshandel, Gholamreza Akhavan Tabib, Atefeh Joshaghani, Hamidreza Middle East J Dig Dis Original Article BACKGROUND Inflammatory bowel diseases are managed by different methods, which may not be well tolerated because of their side effects. Recently, pro-prebiotics are considered as a supplementary treatment in gastrointestinal diseases. In this study, the effect of Lactocare® (ZistTakhmir Company) was investigated on the disease severity in mild to moderate ulcerative colitis. METHODS In this randomized, double-blind clinical trial (Iranian Registry of Clinical Trials number: IRCT201407271264N5), 60 patients with mild to moderate ulcerative colitis were included. An 8-week trial was carried out comparing Lactocare® as a supplement with standard therapy against placebo. Simple Clinical Colitis Activity Index (SCCAI) was measured at baseline and after 8 weeks. Statistical analysis was performed using paired ttest to assess the temporal changes (before and after the treatment) in the mean of SCCAI in each group. Chi-square test was used to compare the response rates. Odds ratios (OR) and the 95% confidence intervals (95%CI) were also calculated. p values of less than 0.05 were considered significant. RESULTS A significant decreased mean SCCAI was seen in the intervention group (4.56 ± 2.56) vs. placebo group (6.54 ± 2.47) (p < 0.05). Response to treatment was seen in 64.3% of the treatment group vs. 47% in the placebo group (p = 0.18). Response to treatment was observed in 90.9% of patients with ulcerative colitis for more than 5 years compared with 44.4% of the control group (p = 0.01). CONCLUSION Regarding the effectiveness of pre-probiotics in mitigating symptoms in patients with ulcerative colitis, it could be suggested to try pre-probiotics in the standard treatment particularly in those with more than five years ofthe disease. Iranian Association of Gastroerterology and Hepatology 2020-01 /pmc/articles/PMC7023645/ /pubmed/32082518 http://dx.doi.org/10.15171/mejdd.2020.160 Text en © 2020 The Author(s) This work is published by Middle East Journal of Digestive Diseaes as an open access article distributed under the terms of the Creative Commons Attribution License https://creativecommons.org/licenses/by-nc/4.0/ Non-commercial uses of the work are permitted, provided the original work is properly cited.
spellingShingle Original Article
Amiriani, Taghi
Rajabli, Niloofar
Faghani, Maryam
Besharat, Sima
Roshandel, Gholamreza
Akhavan Tabib, Atefeh
Joshaghani, Hamidreza
Effect of Lactocare® Synbiotic on Disease Severity in Ulcerative Colitis: A Randomized Placebo-Controlled Double-Blind Clinical Trial
title Effect of Lactocare® Synbiotic on Disease Severity in Ulcerative Colitis: A Randomized Placebo-Controlled Double-Blind Clinical Trial
title_full Effect of Lactocare® Synbiotic on Disease Severity in Ulcerative Colitis: A Randomized Placebo-Controlled Double-Blind Clinical Trial
title_fullStr Effect of Lactocare® Synbiotic on Disease Severity in Ulcerative Colitis: A Randomized Placebo-Controlled Double-Blind Clinical Trial
title_full_unstemmed Effect of Lactocare® Synbiotic on Disease Severity in Ulcerative Colitis: A Randomized Placebo-Controlled Double-Blind Clinical Trial
title_short Effect of Lactocare® Synbiotic on Disease Severity in Ulcerative Colitis: A Randomized Placebo-Controlled Double-Blind Clinical Trial
title_sort effect of lactocare® synbiotic on disease severity in ulcerative colitis: a randomized placebo-controlled double-blind clinical trial
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7023645/
https://www.ncbi.nlm.nih.gov/pubmed/32082518
http://dx.doi.org/10.15171/mejdd.2020.160
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