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IRCT20140208016529N8 IRCT 2023-04-25 Esfahan University of Medical Sciences Effect of spirulina on Irritable bowel syndrome patients Effect of spirulina platensis supplementation on quality of life, severity of disease and serum total antioxidant capacity (TAC), manoldialdehyde (MDA) and zonulin in constipation-predominant Irritable bowel syndrome patients (IBS) 2023-06-06 anticipated 60 Complete https://irct.ir/trial/69739 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed by permuted block randomization method using size 4 blocks by Stata statistical software version 16. To conceal the random assignment process, 10-digit random codes are written on papers labels without a specific order and framework, which is the relevant treatment identification number, and only one person outside the design will be aware of the code. Labels will be affixed to drug packages in a random order list, Blinding description: supplement and placebo are given to both groups in completely identical, unlabeled containers, which are prepared and coded in the same color and odor, by random allocation by the design partner, so neither patient is aware of the specific treatment and will not be informed until the end of the study. Also, the researcher evaluating the desired outcomes is unaware of the random allocation process and the type of treatment performed. N/A Irritable bowel syndrome. Intervention 1: Intervention group: The intervention group will receive two capsule of spirulina (containing 500 mg of spirulina platensis powder) daily after breakfast for 12 weeks. Intervention 2: Control group: The control group will receive two placebo daily that is similar in shape, color, taste, and smell to the supplement. No - There is not a plan to make this available Justification or reason for not sharing IPD is It should be consulted with other members of group according to the university's policies
public Mohammad hassan entezari
School of Nutrition and Food Science, Isfahan University of Medical Sciences, Hezar Jarib Blvd
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3172 entezari@hlth.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad hassan entezari
School of Nutrition and Food Science, Isfahan University of Medical Sciences, Hezar Jarib Blvd
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3172 entezari@hlth.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Ages range of 18-50 years patients diagnosed with irritable bowel syndrome through ROME IV criteria by a gastroenterologist 18 years 50 years Both Smoking Alcohol consumption Pregnancy or breastfeeding condition Taking antidepressants and anxiety medications. Taking antioxidant and omega-3 supplements in the last three months Kidney, liver, thyroid and parathyroid, heart disease, cancer and gastrointestinal diseases other than IBS K58 Irritable bowel syndrome Treatment - Other Placebo Intervention group: The intervention group will receive two capsule of spirulina (containing 500 mg of spirulina platensis powder) daily after breakfast for 12 weeks Control group: The control group will receive two placebo daily that is similar in shape, color, taste, and smell to the supplement Quality of life. Timepoint: At baseline and after 12 weeks. Method of measurement: Irritable bowel syndrome-quality of life- 34 (IBS-QOL-34)questionnaire. Disease severity. Timepoint: At baseline and after 12 weeks. Method of measurement: Irritable bowel syndrome syndrome severity scale(IBS-SSS) questionnaire. Serum zonulin level. Timepoint: At baseline and after 12 weeks. Method of measurement: Eliza kit. Total antioxidant capacity of serum. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetric method. Malonaldehyde. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetric method. Esfahan University of Medical Sciences Approved 2023-02-28 ethics committee of Isfahan university of medical sciences Hezarjrib Street Isfehan Isfehan Iran (Islamic Republic of)