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Effect of Enteral Genistein Supplementation in Sepsis

Primary Purpose

Sepsis

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Genistein
enteral nutrition only
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Enteral nutrition, Genistein, Cytokine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erciyes University Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Genistein

control

Arm Description

Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition

Control group are the patients receiving enteral nutrition

Outcomes

Primary Outcome Measures

Change in Tumor necrosis factor alpha serum levels
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Change in interleukin 1-beta serum levels
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Change in interleukin 6 serum levels
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Change in high-mobility group box 1 serum levels
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study

Secondary Outcome Measures

Number of study participants with development of new pneumonia, urinary tract infection and blood stream infections
Patients will be followed until they are discharged from the hospital or death.
Length of intensive care unit and hospital stay (days)
Patients will be followed until they are discharged from the hospital or death.
Duration of mechanical ventilation
Patients will be followed until they are discharged from the hospital or death.
Intensive care unit mortality rate, hospital mortality rate
Patients will be followed until they are discharged from the hospital or death.

Full Information

First Posted
March 10, 2016
Last Updated
June 7, 2016
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT02796794
Brief Title
Effect of Enteral Genistein Supplementation in Sepsis
Official Title
Effect of Enteral Genistein Supplementation on Inflammatory Cytokines, Morbidity and Mortality in Patients With Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Enteral nutrition, Genistein, Cytokine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Genistein
Arm Type
Active Comparator
Arm Description
Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition
Arm Title
control
Arm Type
Other
Arm Description
Control group are the patients receiving enteral nutrition
Intervention Type
Dietary Supplement
Intervention Name(s)
Genistein
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
enteral nutrition only
Intervention Description
These are the patients receiving enteral nutrition
Primary Outcome Measure Information:
Title
Change in Tumor necrosis factor alpha serum levels
Description
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Time Frame
Baseline, at 24th hour and at 72nd hour
Title
Change in interleukin 1-beta serum levels
Description
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Time Frame
Baseline, at 24th hour and at 72nd hour
Title
Change in interleukin 6 serum levels
Description
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Time Frame
Baseline, at 24th hour and at 72nd hour
Title
Change in high-mobility group box 1 serum levels
Description
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Time Frame
Baseline, at 24th hour and at 72nd hour
Secondary Outcome Measure Information:
Title
Number of study participants with development of new pneumonia, urinary tract infection and blood stream infections
Description
Patients will be followed until they are discharged from the hospital or death.
Time Frame
From date of randomization until 12 weeks
Title
Length of intensive care unit and hospital stay (days)
Description
Patients will be followed until they are discharged from the hospital or death.
Time Frame
From date of randomization until 12 weeks
Title
Duration of mechanical ventilation
Description
Patients will be followed until they are discharged from the hospital or death.
Time Frame
From date of randomization until 12 weeks
Title
Intensive care unit mortality rate, hospital mortality rate
Description
Patients will be followed until they are discharged from the hospital or death.
Time Frame
From date of randomization until 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kursat Gundogan, MD
Phone
+90 352 207 6666
Ext
21919
Email
kgundogan@erciyes.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Murat Sungur, MD
Phone
+90 352 207 6666
Ext
21912
Email
msungur@erciyes.edu.tr
Facility Information:
Facility Name
Erciyes University Medical School
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kudret Dogru, MD
Phone
+90 352 207 6666
Ext
20000
Email
kdogru@erciyes.edu.tr
First Name & Middle Initial & Last Name & Degree
Emine Alp, MD
Phone
+90 352 207 6666
Ext
20000
Email
ealp@erciyes.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24614013
Citation
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.
Results Reference
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PubMed Identifier
22397815
Citation
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.
Results Reference
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PubMed Identifier
16847837
Citation
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.
Results Reference
background
PubMed Identifier
23984731
Citation
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.
Results Reference
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Effect of Enteral Genistein Supplementation in Sepsis

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