- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02796794
Effect of Enteral Genistein Supplementation in Sepsis
Effect of Enteral Genistein Supplementation on Inflammatory Cytokines, Morbidity and Mortality in Patients With Sepsis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sepsis is a state develops as a response to severe infection with high mortality rate. Incidence of sepsis among patients admitted to hospitals is 2%. Annual incidence of sepsis is 50-95 for 100.000 population and incidence is increasing approximately 9% each year. Severe sepsis and septic shock is the most frequent reason for mortality in intensive care units (ICU). There is exaggerated and irregular host response in sepsis. Cytokines such as interleukin-1, interleukin-6, interleukin-8, tumor necrosis factor-α, Interferon-γ and high mobility group box-1 are released as response to invading microorganisms and they play a major role in sepsis pathogenesis.
Soybean proteins are used for prevention and treatment of cardiovascular diseases, osteoporosis and different cancer types.
Soy isoflavones such as genistein, daidzein and glycitein are the main components for cancer prevention. Genistein is the dominant isoflavones.
The main mechanism for anti-inflammatory effect of genistein is related to transcription nuclear factor (NF-kB) and inhibition of chemokine-8. The risk for prostate cancer was proven to decrease in epidemiological studies.
NF-kB plays a central role for inflammatory cytokine release, prevents apoptosis and induces tumor cell growth. The effect of topoisomerase II inhibitory chemotherapeutic agents is increased with NF-kB inhibition.
Hypothesis
- Addition of genistein to enteral nutrition in patients with sepsis can play an important role to decrease inflammatory cytokines.
- Morbidity can be decreased with lower levels of inflammatory cytokines in patients with sepsis.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Kursat Gundogan, MD
- Phone Number: 21919 +90 352 207 6666
- Email: kgundogan@erciyes.edu.tr
Study Locations
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Kayseri, Turkey, 38039
- Recruiting
- Erciyes University Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Criteria: inclusion criteria:
- Patients with sepsis above 18 years of age.
- Expected duration of ICU survival more than 48 hours.
- Patients receiving enteral nutrition (EN)
- Sepsis diagnosis within first 12 hours
Exclusion Criteria:
- Presence of thyroid dysfunction
- Presence of hyperlipidemia
- Patients with nill by mouth and not receiving enteral nutrition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Genistein
Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition
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Total 30 patients will be included into the study They will be divided into two groups each containing 15 patients.
Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition
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Other: control
Control group are the patients receiving enteral nutrition
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These are the patients receiving enteral nutrition
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Tumor necrosis factor alpha serum levels
Time Frame: Baseline, at 24th hour and at 72nd hour
|
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
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Baseline, at 24th hour and at 72nd hour
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Change in interleukin 1-beta serum levels
Time Frame: Baseline, at 24th hour and at 72nd hour
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It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
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Baseline, at 24th hour and at 72nd hour
|
Change in interleukin 6 serum levels
Time Frame: Baseline, at 24th hour and at 72nd hour
|
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
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Baseline, at 24th hour and at 72nd hour
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Change in high-mobility group box 1 serum levels
Time Frame: Baseline, at 24th hour and at 72nd hour
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It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
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Baseline, at 24th hour and at 72nd hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of study participants with development of new pneumonia, urinary tract infection and blood stream infections
Time Frame: From date of randomization until 12 weeks
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Patients will be followed until they are discharged from the hospital or death.
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From date of randomization until 12 weeks
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Length of intensive care unit and hospital stay (days)
Time Frame: From date of randomization until 12 weeks
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Patients will be followed until they are discharged from the hospital or death.
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From date of randomization until 12 weeks
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Duration of mechanical ventilation
Time Frame: From date of randomization until 12 weeks
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Patients will be followed until they are discharged from the hospital or death.
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From date of randomization until 12 weeks
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Intensive care unit mortality rate, hospital mortality rate
Time Frame: From date of randomization until 12 weeks
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Patients will be followed until they are discharged from the hospital or death.
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From date of randomization until 12 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available. Erratum In: N Engl J Med. 2013 Nov 21;369(21):2069.
- Souza LR, Silva E, Calloway E, Kucuk O, Rossi M, McLemore ML. Genistein protects hematopoietic stem cells against G-CSF-induced DNA damage. Cancer Prev Res (Phila). 2014 May;7(5):534-44. doi: 10.1158/1940-6207.CAPR-13-0295. Epub 2014 Mar 10.
- Lazarevic B, Hammarstrom C, Yang J, Ramberg H, Diep LM, Karlsen SJ, Kucuk O, Saatcioglu F, Tasken KA, Svindland A. The effects of short-term genistein intervention on prostate biomarker expression in patients with localised prostate cancer before radical prostatectomy. Br J Nutr. 2012 Dec 28;108(12):2138-47. doi: 10.1017/S0007114512000384. Epub 2012 Mar 8.
- Hong H, Landauer MR, Foriska MA, Ledney GD. Antibacterial activity of the soy isoflavone genistein. J Basic Microbiol. 2006;46(4):329-35. doi: 10.1002/jobm.200510073.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Sepsis
- Toxemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protective Agents
- Estrogens, Non-Steroidal
- Estrogens
- Protein Kinase Inhibitors
- Anticarcinogenic Agents
- Phytoestrogens
- Genistein
Other Study ID Numbers
- 2014/341
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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