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Effect of Enteral Genistein Supplementation in Sepsis

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ClinicalTrials.gov Identifier: NCT02796794
Recruitment Status : Unknown
Verified June 2016 by Kursat Gundogan, TC Erciyes University.
Recruitment status was:  Recruiting
First Posted : June 13, 2016
Last Update Posted : June 13, 2016
Sponsor:
Information provided by (Responsible Party):
Kursat Gundogan, TC Erciyes University

Brief Summary:
To evaluate effects of genistein supplementation to enteral nutrition on inflammatory cytokines and morbidity in patients with sepsis

Condition or disease Intervention/treatment Phase
Sepsis Dietary Supplement: Genistein Other: enteral nutrition only Phase 4

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

  1. Addition of genistein to enteral nutrition in patients with sepsis can play an important role to decrease inflammatory cytokines.
  2. Morbidity can be decreased with lower levels of inflammatory cytokines in patients with sepsis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Enteral Genistein Supplementation on Inflammatory Cytokines, Morbidity and Mortality in Patients With Sepsis
Study Start Date : June 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
Drug Information available for: Genistein

Arm Intervention/treatment
Active Comparator: Genistein
Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition
Dietary Supplement: Genistein
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

control
Control group are the patients receiving enteral nutrition
Other: enteral nutrition only
These are the patients receiving enteral nutrition




Primary Outcome Measures :
  1. 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

  2. Change in interleukin 1-beta 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

  3. 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

  4. Change in high-mobility group box 1 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


Secondary Outcome Measures :
  1. 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 ]
    Patients will be followed until they are discharged from the hospital or death.

  2. Length of intensive care unit and hospital stay (days) [ Time Frame: From date of randomization until 12 weeks ]
    Patients will be followed until they are discharged from the hospital or death.

  3. Duration of mechanical ventilation [ Time Frame: From date of randomization until 12 weeks ]
    Patients will be followed until they are discharged from the hospital or death.

  4. Intensive care unit mortality rate, hospital mortality rate [ Time Frame: From date of randomization until 12 weeks ]
    Patients will be followed until they are discharged from the hospital or death.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796794


Contacts
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Contact: Kursat Gundogan, MD +90 352 207 6666 ext 21919 kgundogan@erciyes.edu.tr
Contact: Murat Sungur, MD +90 352 207 6666 ext 21912 msungur@erciyes.edu.tr

Locations
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Turkey
Erciyes University Medical School Recruiting
Kayseri, Turkey, 38039
Contact: Kudret Dogru, MD    +90 352 207 6666 ext 20000    kdogru@erciyes.edu.tr   
Contact: Emine Alp, MD    +90 352 207 6666 ext 20000    ealp@erciyes.edu.tr   
Sponsors and Collaborators
TC Erciyes University

Publications:
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Responsible Party: Kursat Gundogan, MD, TC Erciyes University
ClinicalTrials.gov Identifier: NCT02796794     History of Changes
Other Study ID Numbers: 2014/341
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Kursat Gundogan, TC Erciyes University:
Enteral nutrition
Genistein
Cytokine

Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Genistein
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists