Investigating the effect of zinc supplementation separately and in combination with probiotics in irritable bowel syndrome

Phase 3

• Conditions: Irritable bowel syndrome.; Irritable bowel syndrome

• Registration Number: IRCT20180818040827N5
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.