]>
IRCT20180818040827N5 IRCT 2024-01-29 Esfahan University of Medical Sciences Investigating the effect of zinc supplementation separately and in combination with probiotics in irritable bowel syndrome The effect of zinc supplementation separately and in combination with probiotics on inflammatory and oxidative stress indicators, the severity of gastrointestinal symptoms, mood disorders, quality of life and sleep in patients with irritable bowel syndrome: a double-blind randomized controlled clinical trial 2024-07-22 anticipated 84 Complete https://irct.ir/trial/75117 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 84 people will be included according to the included criteria. Participants will be divided into three groups (two intervention and one control group) using balanced (permuted) block randomization. Considering the three groups of the study, blocks of six will be considered, and the classification will be applied based on the gender variable. The reliable site (https://www.sealedenvelope.com/simple-randomiser/v1/lists) will be used to allocate the intervention in the mentioned way. It is worth noting that the participants and outcome assessors will not know about the grouping of patients and will be blind to it, Blinding description: This study is a randomized double-blind clinical trial. Zinc supplement, probiotic supplement and their placebo will be packed in the same boxes in terms of appearance characteristics (color, shape, smell) and the researcher, patients, evaluators, and those responsible for collecting data will not be informed of the contents of the packages until the end of the study. 3 Irritable bowel syndrome. Intervention 1: Intervention group: zinc gluconate 20 mg and probiotic placebo daily for 12 weeks. Intervention 2: Intervention group: 20 mg zinc gluconate and probiotic capsule daily for 12 weeks. Intervention 3: Control group: zinc and probiotic placebos (microcrystalline cellulose) daily for 12 weeks. Yes - There is a plan to make this available What will be shared: Major part of information will be available for population. When: 12 months after publication To whom: Available for people working in academic institutions Conditions: To conduct similar studies Where to obtain: r_amani@nutr.mui.ac.ir How to obtain: The data will be sent as soon as possible, after receiving the request Comments:
public Mahsa Rezazadegan
Hezar Jerib
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3175 mahsarezazadegan75@gmail.com Esfahan University of Medical Sciences scientific Dr. Reza Amani
Hezar Jerib
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3175 r_amani@nutr.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who agree to participate in the study. Diagnosis of IBS by a gastroenterologist based on the Rome IV criteria Body mass index between 18.5 to 40 20 years 60 years Both Regular consumption of probiotics and prebiotics products and supplements at least 2 months before the start of the study Taking zinc supplement in the last 6 months or following a special diet History of gastrointestinal surgery, celiac disease, infection or cancer of the gastrointestinal tract, inflammatory bowel diseases, rheumatism and other inflammatory diseases and malignancy Pregnant, breastfed, or hospitalized Allergy to the ingredients in the supplement Drinking alcohol, smoking Penicillamine use, regular use of anti-diarrheal or laxative drugs, antibiotics, use of drugs that alter digestive movements, use of drugs that increase bleeding from intestinal mucus such as warfarin, heparin Professional athletes All types of anemia K58 Irritable bowel syndrome Treatment - Other Treatment - Other Placebo Intervention group: zinc gluconate 20 mg and probiotic placebo daily for 12 weeks Intervention group: 20 mg zinc gluconate and probiotic capsule daily for 12 weeks Control group: zinc and probiotic placebos (microcrystalline cellulose) daily for 12 weeks Serum zinc level. Timepoint: Before and after the intervention. Method of measurement: Assay kit. Total antioxidant capacity. Timepoint: Before and after the intervention. Method of measurement: Assay kit. Gastrointestinal symptom severity. Timepoint: Before and after the intervention. Method of measurement: IBS Severity Score questionnaire. Tumor necrosis factor alpha. Timepoint: Before and after the intervention. Method of measurement: Assay kit. Malondialdehyde. Timepoint: Before and after the intervention. Method of measurement: Assay kit. Total oxidant status. Timepoint: Before and after the intervention. Method of measurement: Assay kit. Oxidative stress index. Timepoint: Before and after the intervention. Method of measurement: Calculation. Superoxide dismutase. Timepoint: Before and after the intervention. Method of measurement: Assay kit. Depression, anxiety and stress. Timepoint: Before and after the intervention. Method of measurement: Depression Anxiety and Stress Scale 21. Quality of life. Timepoint: Before and after the intervention. Method of measurement: Irritable Bowel Syndrome Quality of Life questionnaire. Sleep quality. Timepoint: Before and after the intervention. Method of measurement: Pittsburgh Sleep Quality questionnaire. Fatigue severity. Timepoint: Before and after the intervention. Method of measurement: Fatigue Severity Scale questionnaire. Emotional patterns. Timepoint: Before and after the intervention. Method of measurement: Positive and Negative Affect Schedule questionnaire. Anthropometric measurements. Timepoint: Before and after the intervention. Method of measurement: Omron BF-511 scale and tape measure. Esfahan University of Medical Sciences Approved 2024-01-20 Research Ethics Committees of Schools of Pharmacy and Nutrition, Isfahan University of Medical Scien Hezar Jerib Isfahan Isfehan Iran (Islamic Republic of)