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)

evaluating effect of spirulina platensis supplementation on quality of life, severity of disease and serum total antioxidant capacity, manoldialdehyde and zonulin in constipation-predominant Irritable bowel syndrome patients

A parallel randomized double-blind (patients and investigator ) placebo-controlled clinical trial. this study will be conducted on 60 patients. Permuted block randomization is used for randmization.

This study will be conducted in the clinic of gastrointestinal health center of Isfahan university of medical sciences. The intervention group will receive two tablet of spirulina (containing 500 mg of spirulina powder) daily after breakfast and dinner and the control group will receive two placebos daily, which are similar in shape, color, taste, and smell. Patients and researchers are not aware of how randomly assigned individuals are. At the beginning and end of the study, venous blood samples, anthropometric measurements, questionnaires related to IBS, demographic information and socio-economic status of patients will be measured and recorded.

Inclusion criteria: Age range of 18-50 years, patients diagnosed with irritable bowel syndrome through ROME IV criteria by a gastroenterologist; Exclusion criteria: 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

Patients will be assigned to receive spirulina supplements (n=30) and placebo (n=30)

quality of life, disease severity and serum zonulin level

Considering the request from the journal where the protocol is currently under review, the disease subtype must be added to the title and inclusion criteria. Additionally, as the study has been completed, we request the addition of the sample collection end date to the registry.

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.

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.

It should be consulted with other members of group according to the university's policies