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

Sima Besharat, Taghi Amiriani, Niloofar Rajabli, Maryam Faghani, Gholamreza Roshandel, Atefeh Akhavan Tabib, Hamidreza Joshaghani



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.



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. Pvalues of less than 0.05 were considered significant.



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).



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.


Ulcerative colitis, Pre-probiotics, Simple Clinical Colitis Activity Index (SCCAI)

Full Text:


Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.