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							| Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007



	

				
						
 
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																Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007
										

				


				
				
					
					
						
																					
				
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					Vol. 13 No. 11 (2023): November 2023
				
				/
			
	
			
									Clinical Trial
							
		



	
		  	 

		
	
		The effects of probiotics in ulcerative colitis patients: a randomized controlled double blind clinical trial
	


	
	
		

							
					Authors

						
							
								Babak Tamizifar
							
																																		
	
							
								Awat Feizi
							
																																		
	
							
								Marzieh Rahim khorasani
							
																																		
	
							
								Nazila Kassaian
							
																																		
	
							
								Ali Zamanimoghadam
							
																																		
	
							
								Shayan Arbabnia
							
																																		
	
							
								Peyman Adibi Sede
							
																																		


				
			
																	
					
												DOI:
					

					
						
							https://doi.org/10.31989/ffhd.v13i11.1098
						
					
				
			

						
										
					Abstract

					Background: In the recent decade, ulcerative colitis (UC) as a chronic inflammatory bowel disease has a growing incidence and prevalence in the world.Probiotics might be a promising approach to improve ulcerative colitis by favorably modifying the gut microbiota.  
Methods: A double-blind, randomized, placebo-controlled, parallel-group clinical trial was conducted on sixty patients with mild/moderate ulcerative colitis. Participants were administered either placebo (n = 30) or a multi-strain probiotic (n= 30) for 16 weeks. Clinical disease status, via Lichtiger and Mayo questionnaires, was assessed at baseline and after 8 and 16 weeks of intervention. Fecal calprotectin was measured before and after the study period. Within and between groups, comparisons were made using per-protocol (PP) and intention-to-treat (ITT) approaches, and a P-value≤0.05 was considered a statistically significant level. 
Results: Of the sixty patients who agreed to participate in the study, 18 dropped out during the study due to low compliance and gastrointestinal complications. The two groups were comparable in baseline variables (P>0.05). During the study, the within and between groups’ diﬀerences of calprotectin and Mayo scores were not statistically significant. Although the mean score of Lichtiger was significantly decreased in the probiotic group during the study period (P = 0.001), no statistically significant differences compared with the placebo group were seen.
Conclusion: Our study elucidated that probiotic supplementation does not significantly improve UC patients, which may be due to the strain and dose administered. Future research should focus on the best effective strains and doses for ulcerative colitis.

Keywords:probiotic, ulcerative colitis, IBD, clinical trial

				
			
			

						
																																																													
						
		


		

						
										
					
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						Published
					

					
																			2023-11-15
																	

				
							

			
						
										

											
							
								Issue
							

							
								
									Vol. 13 No. 11 (2023): November 2023
								
							

						
					
											
							
								Section
							

							
								Clinical Trial
							

						
					
									

			
						
										
					
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