SepsisPhase 4NCT02796794
Effect of Enteral Genistein Supplementation in Sepsis
A Phase 4 study testing Genistein and enteral nutrition only in people with Sepsis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate effects of genistein supplementation to enteral nutrition on inflammatory cytokines and morbidity in patients with sepsis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Genistein and enteral nutrition only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2015to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Presence of thyroid dysfunction
- Presence of hyperlipidemia
- Patients with nill by mouth and not receiving enteral nutrition
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University Medical School
Kayseri, 38039
Kudret Dogru, MD, +90 352 207 6666 ext. 20000, kdogru@erciyes.edu.tr
Emine Alp, MD, +90 352 207 6666 ext. 20000, ealp@erciyes.edu.tr
About this study
Official title: Effect of Enteral Genistein Supplementation on Inflammatory Cytokines, Morbidity and Mortality in Patients With Sepsis
To evaluate effects of genistein supplementation to enteral nutrition on inflammatory cytokines and morbidity in patients with sepsis
Read the 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.
- Conditions
- Sepsis
- Being tested
- Genistein, enteral nutrition only
- Keywords
- Enteral nutrition, Genistein, Cytokine
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenisteinDietary supplement
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
enteral nutrition onlyOther
These are the patients receiving enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| Genistein | Active comparator | Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition Receives: Dietary Supplement: Genistein |
| control | Other | Control group are the patients receiving enteral nutrition Receives: Other: enteral nutrition only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, at 24th hour and at 72nd hour
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
Measured: Baseline, at 24th hour and at 72nd hour
Change in interleukin 6 serum levels
It will be measured at baseline, at 24th hour and at 72nd hour after inclusion into the study
Measured: Baseline, at 24th hour and at 72nd hour
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
Measured: Baseline, at 24th hour and at 72nd hour
Secondary outcomes (4)
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.
Measured: From date of randomization until 12 weeks
Length of intensive care unit and hospital stay (days)
Patients will be followed until they are discharged from the hospital or death.
Measured: From date of randomization until 12 weeks
Duration of mechanical ventilation
Patients will be followed until they are discharged from the hospital or death.
Measured: From date of randomization until 12 weeks
Intensive care unit mortality rate, hospital mortality rate
Patients will be followed until they are discharged from the hospital or death.
Measured: From date of randomization until 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kursat Gundogan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796794
- Sponsor's protocol ID
- 2014/341
- Status last verified
- Jun 2016
- First submitted
- 10 Mar 2016
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24614013Lazarevic 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.
PubMed 22397815Hong 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.
PubMed 16847837Angus 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.
PubMed 23984731
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enteral Genistein Supplementation on Inflammatory Cytokines, Morbidity and Mortality in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT02796794
- Acronym / sponsor ID
- 2014/341
- Conditions
- Sepsis
- Keywords
- Enteral nutrition, Genistein, Cytokine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genistein | Active comparator | Dietary Supplement: GenisteinIntervention group will receive supplemental genistein (60 mg/day) to enteral nutrition |
| control | Other | Other: enteral nutrition onlyControl group are the patients receiving enteral nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Presence of thyroid dysfunction
- Presence of hyperlipidemia
- Patients with nill by mouth and not receiving enteral nutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenisteinTotal 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 | Dietary supplement | Genistein |
| enteral nutrition onlyThese are the patients receiving enteral nutrition | Other | control |
Primary outcome
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
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
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
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
4 secondary outcomes
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
Length of intensive care unit and hospital stay (days)
Time frame: From date of randomization until 12 weeks
Duration of mechanical ventilation
Time frame: From date of randomization until 12 weeks
Intensive care unit mortality rate, hospital mortality rate
Time frame: From date of randomization until 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
- Background: PubMed 24614013Souza 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.
- Background: PubMed 22397815Lazarevic 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.
- Background: PubMed 16847837Hong 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.
- Background: PubMed 23984731Angus 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Genistein and enteral nutrition only in people with Sepsis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kursat Gundogan, MD (+90 352 207 6666 ext. 21919, kgundogan@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tumor necrosis factor alpha serum levels (time frame: Baseline, at 24th hour and at 72nd hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02796794, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2016.