Protocol summary
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Study aim
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To study the effects of zinc and probiotic on oxidative stress and inflammation, clinical, and mood variables in irritable bowel syndrome (IBS)
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Design
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84 patients will be randomly allocated to one of three groups. variables will be evaluated using valid questionnaires, tools, and lab tests.
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Settings and conduct
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The participants will be selected among IBS patients referred to the special clinic of Khorshid Hospital and Gastrointestinal Health Center of Al-Zahra Hospital in Isfahan, who were diagnosed by a gastroenterologist according to Rome IV criteria. Patients will be included in the study based on the inclusion criteria. Written informed consent will be obtained from all participants. Then, people will be randomly assigned to one of the 3 intervention groups. Anthropometric indicators will be measured and questionnaires will be completed. Arrangements will be made to perform the blood test on a certain day. Participants and outcome assessors will be blinded and unaware of the grouping of patients.
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Participants/Inclusion and exclusion criteria
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IBS patients aged 20 to 60 years with a body mass index of 18.5 to 40
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Intervention groups
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Group 1: zinc gluconate 20 mg and probiotic placebo
Group 2: 20 mg zinc gluconate and probiotic capsule
Group 3: zinc and probiotic placebos (microcrystalline cellulose)
daily for 12 weeks
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Main outcome variables
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Serum zinc; tumor necrosis factor alpha; malondialdehyde; total oxidative status; total antioxidant capacity; Oxidative stress index; Superoxide dismutase; severity of gastrointestinal symptoms; depression; anxiety and stress; Quality of Life; sleep quality
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180818040827N5
Registration date:
2024-01-29, 1402/11/09
Registration timing:
prospective
Last update:
2025-09-28, 1404/07/06
Update count:
1
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Registration date
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2024-01-29, 1402/11/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-07-22, 1403/05/01
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Expected recruitment end date
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2025-07-23, 1404/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Investigating the effect of zinc supplementation separately and in combination with probiotics in irritable bowel syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-01-20, 1402/10/30
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Ethics committee reference number
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IR.MUI.PHANUT.REC.1402.079
Health conditions studied
1
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Description of health condition studied
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Irritable bowel syndrome
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ICD-10 code
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K58
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ICD-10 code description
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Irritable bowel syndrome
Primary outcomes
1
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Description
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Serum zinc level
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Timepoint
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Before and after the intervention
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Method of measurement
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Assay kit
2
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Description
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Total antioxidant capacity
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Timepoint
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Before and after the intervention
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Method of measurement
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Assay kit
3
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Description
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Gastrointestinal symptom severity
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Timepoint
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Before and after the intervention
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Method of measurement
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IBS Severity Score questionnaire
Secondary outcomes
1
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Description
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Tumor necrosis factor alpha
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Timepoint
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Before and after the intervention
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Method of measurement
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Assay kit
2
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Description
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Malondialdehyde
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Timepoint
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Before and after the intervention
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Method of measurement
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Assay kit
3
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Description
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Total oxidant status
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Timepoint
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Before and after the intervention
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Method of measurement
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Assay kit
4
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Description
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Oxidative stress index
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Timepoint
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Before and after the intervention
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Method of measurement
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Calculation
5
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Description
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Superoxide dismutase
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Timepoint
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Before and after the intervention
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Method of measurement
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Assay kit
6
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Description
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Depression, anxiety and stress
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Timepoint
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Before and after the intervention
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Method of measurement
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Depression Anxiety and Stress Scale 21
7
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Description
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quality of life
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Timepoint
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Before and after the intervention
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Method of measurement
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Irritable Bowel Syndrome Quality of Life questionnaire
8
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Description
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sleep quality
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Timepoint
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Before and after the intervention
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Method of measurement
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Pittsburgh Sleep Quality questionnaire
9
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Description
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Fatigue severity
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Timepoint
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Before and after the intervention
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Method of measurement
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Fatigue Severity Scale questionnaire
10
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Description
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Emotional patterns
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Timepoint
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Before and after the intervention
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Method of measurement
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Positive and Negative Affect Schedule questionnaire
11
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Description
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Anthropometric measurements
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Timepoint
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Before and after the intervention
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Method of measurement
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Omron BF-511 scale and tape measure
Intervention groups
1
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Description
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Intervention group: zinc gluconate 20 mg and probiotic placebo daily for 12 weeks
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Category
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Treatment - Other
2
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Description
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Intervention group: 20 mg zinc gluconate and probiotic capsule daily for 12 weeks
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Category
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Treatment - Other
3
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Description
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Control group: zinc and probiotic placebos (microcrystalline cellulose) daily for 12 weeks
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Major part of information will be available for population.
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When the data will become available and for how long
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12 months after publication
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To whom data/document is available
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Available for people working in academic institutions
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Under which criteria data/document could be used
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To conduct similar studies
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From where data/document is obtainable
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r_amani@nutr.mui.ac.ir
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What processes are involved for a request to access data/document
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The data will be sent as soon as possible, after receiving the request
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Comments
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