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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180818040827N5

Enrollment

Registered

2024-01-29

Start date

2024-07-22

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable bowel syndrome. Irritable bowel syndrome

Interventions

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. In

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Gastrointestinal symptom severity. Timepoint: Before and after the intervention. Method of measurement: IBS Severity Score questionnaire.;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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahsa Rezazadegan

Esfahan University of Medical Sciences

mahsarezazadegan75@gmail.com+98 31 3792 3175

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026