SepsisNCT05623098
Effects of Dietary Fiber on Bone Metabolism
An observational study of Sepsis, run by Zhujiang Hospital at 1 site in China.
Trial summary
Clinical and animal studies have found that sepsis can lead to a serious imbalance in the gut microecology, a reduction in probiotics, a reduction in short-chain fatty acid, a reduction in bone mass, and an increase in bone destruction, maintaining the stability of microecology can be one of the effective means of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sepsis
- What is being tested?
- dietary fiber nutrients
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 Dec 2024
- Phase
- Observational
- 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 to 70 years
- All sexes
- Adult, Older adult
Study population: 1) sepsis 20163.0: infection + sequential organ failure assessment (Sofa) score ≥2 points. (rapid SOFA (qSOFA) scoring tool criteria: (1) respiratory frequency ≥22 beats/min; (2) change in state of consciousness; (3) systolic blood pressure ≤100 mm Hg) .
Who may be able to join
- The subjects voluntarily cooperated with the study and signed the informed consent form, and could be followed up
- Age 18-70
- It meets the diagnostic criteria of Sepsis 2016 Sepsis 3.0 guidelines
- After treatment, the Hemodynamics is stable and the patient is ready to start enteral nutrition support
- Those who need tube feeding for more than 14 days because of the need of illness and can not take food by mouth
Who cannot join
- People who have had osteoporosis in the past
- Admission due to fracture
- The shock was not corrected, and the patients were maintained with a large amount of vaso-active drugs (0.5 ug/kg/min of noradrenaline) , but could not be given enteral nutrition
- Supplement with probiotics or prebiotics alone
- Parturients
- No written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dietary Fiber Enteral Nutrition on Bone Metabolism in Septic Patients
Clinical and animal studies have found that sepsis can lead to a serious imbalance in the gut microecology, a reduction in probiotics, a reduction in short-chain fatty acid, a reduction in bone mass, and an increase in bone destruction, maintaining the stability of microecology can be one of the effective means of bone protection. But at present, the treatment of sepsis with early supplementation of probiotics is still controversial, and dietary fiber intake has significantly changed the composition of the microbiota, it may be a safe and effective method to prevent bone loss in sepsis. Further study on it will provide reliable theoretical basis and intervention target for early, safe and effective prevention of osteoporosis.
Read the detailed description
In recent years, researchers have found that the incidence of bone loss in ICU patients is significantly higher than that in the control group of the same age, patients with sepsis whose bone balance is disrupted by higher overresorption, bone destruction and release of multiple active cytokines and toxins become the"Invisible killer"of the ICU, however, the pathogenesis of osteoporosis is not clear, and the existing drugs for osteoporosis can not be safely used in critically ill patients. The gastrointestinal tract is the"Initiating organ"and"Central organ" of multiple organ dysfunction and forms a complex and powerful"Gut-bone axis"with bone, which plays a key role in bone metabolism, but the mechanism is unclear. The human gut contains a dense and diverse microbial community, which plays an important role in nutrition, metabolism and immunity, small intestinal microecology can affect bone turnover through a variety of pathways, especially the metabolite short-chain fatty acid FAS (SCFAs) , which can inhibit osteoclast activity by regulating inflammatory cytokines and immune cells, promote the formation of osteoblasts and other aspects to maintain the stability of bone metabolism, and then protect the health of bones, forming a"Gut-microcology-bone"axis.
Clinical and animal studies have found that sepsis can lead to a serious imbalance in the gut microecology, a reduction in probiotics, a reduction in short-chain fatty acid, a reduction in bone mass, and an increase in bone destruction, maintaining the stability of microecology can be one of the effective means of bone protection. But at present, the treatment of sepsis with early supplementation of probiotics is still controversial, and dietary fiber intake has significantly changed the composition of the microbiota, it may be a safe and effective method to prevent bone loss in sepsis. Further study on it will provide reliable theoretical basis and intervention target for early, safe and effective prevention of osteoporosis. Therefore, based on the above research background, Investigators intend to evaluate the overall safety and efficacy of dietary fiber-containing enteral nutrition supplementation in patients with sepsis by observing changes in bone metabolism-related indicators, to provide the basis for further basic and mechanism research
- Conditions
- Sepsis
- Being tested
- dietary fiber nutrients
- Keywords
- short-chain fatty acid, sepsis, bone metabolism
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary fiber nutrientsDietary supplement
Whether to add nutrients containing dietary fiber
| Study group | Role | What they receive |
|---|---|---|
| Dietary fiber was not added to enteral nutrition preparation | Dietary fiber was not added to enteral nutrition preparation | |
| Dietary fiber was added to enteral nutrition preparation | Dietary fiber was added to enteral nutrition preparation Receives: Dietary Supplement: dietary fiber nutrients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of bone metabolic markers β-CTX
The venous blood was drawn daily before and after the enrollment (the first, third, seventh and fourteenth days) ，and β- CTX for comparison
Measured: 28 day
The changes of bone metabolic markers PINP
Measured: 28 day
Secondary outcomes (9)
Changes in intestinal flora
Collect stool before and after the enrollment (the first, third, seventh and fourteenth days) ，observe the changes of intestinal flora in the two groups. Total bacterial DNA were extracted from samples using the QIAamp DNA stool Mini Kit from Qiagen according to the manufacture's protocol.
Measured: 28 day
Changes in short-chain fatty acid of metabolites
Collect stool before and after the enrollment (the first, third, seventh and fourteenth days) ，observe the changes of metabolite short chain fatty acids in the two groups. Fresh feces were collected and frozen in liquid nitrogen timely.SCFAs was extracted and quantified using a Metrohm ion chromatograph(850 Professional Ic, Metrohm, Herisau, Switzerlan) system
Measured: 28 day
Abdominal symptoms (abdominal distention)
To evaluate and compare the difference of abdominal symptoms (abdominal distension) between the two groups，It is divided into three levels according to the severity of abdominal distension, it can be divided into light, medium and severe (for example:Mild, soft abdomen, tolerable，Moderate: abdominal bulge, obvious discomfort，Severe: abdominal muscles are obviously tense/intolerable)
Measured: 28 day
Abdominal symptoms ( diarrhea incidence)
To evaluate and compare the difference of abdominal symptoms (diarrhea incidence ) between the two groups，it can be divided into light, medium and severe (for example:Mild, 3-5 times/day, 250-500ml/day，Moderate:>5 times/day, 500-1000ml/day,Severity:>5 times/day,>1500ml/day)
Measured: 28 day
The change of systemic inflammatory response index: the value of TNF-α in systemic inflammatory response
The changes of TNF-α were observed and compare before and after treatment, It can be tested in the laboratory of our hospital, the higher the value, the heavier the infection.
Measured: 28 day
The change of systemic inflammatory response index: the value of IL-6 in systemic inflammatory response
The changes of IL-6 were observed and compare before and after treatment. It can be tested in the laboratory of our hospital, the higher the value, the heavier the infection
Measured: 28 day
The change of systemic inflammatory response index: the value of Procalcitonin in systemic inflammatory response
The changes of procalcitonin were observed and compare before and after treatment, the higher the value, the heavier the infection
Measured: 28 day
Length of ICU stay
The total hospitalization time were observed before and after treatment
Measured: 28 day
Length of Apache II score
The total Apache II score were observed before and after treatment，The higher the score is, the more serious the disease is.
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cuiping Liu, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623098
- Sponsor's protocol ID
- 2022LX0036_GC
- Status last verified
- Nov 2022
- First submitted
- 31 Aug 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Fiber Enteral Nutrition on Bone Metabolism in Septic Patients
- ClinicalTrials.gov ID
- NCT05623098
- Acronym / sponsor ID
- 2022LX0036_GC
- Conditions
- Sepsis
- Keywords
- short-chain fatty acid, sepsis, bone metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Nov 2022 (actual)
- 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.
Clinical and animal studies have found that sepsis can lead to a serious imbalance in the gut microecology, a reduction in probiotics, a reduction in short-chain fatty acid, a reduction in bone mass, and an increase in bone destruction, maintaining the stability of microecology can be one of the effective means of bone protection. But at present, the treatment of sepsis with early supplementation of probiotics is still controversial, and dietary fiber intake has significantly changed the composition of the microbiota, it may be a safe and effective method to prevent bone loss in sepsis. Further study on it will provide reliable theoretical basis and intervention target for early, safe and effective prevention of osteoporosis.
Detailed description
In recent years, researchers have found that the incidence of bone loss in ICU patients is significantly higher than that in the control group of the same age, patients with sepsis whose bone balance is disrupted by higher overresorption, bone destruction and release of multiple active cytokines and toxins become the"Invisible killer"of the ICU, however, the pathogenesis of osteoporosis is not clear, and the existing drugs for osteoporosis can not be safely used in critically ill patients. The gastrointestinal tract is the"Initiating organ"and"Central organ" of multiple organ dysfunction and forms a complex and powerful"Gut-bone axis"with bone, which plays a key role in bone metabolism, but the mechanism is unclear. The human gut contains a dense and diverse microbial community, which plays an important role in nutrition, metabolism and immunity, small intestinal microecology can affect bone turnover through a variety of pathways, especially the metabolite short-chain fatty acid FAS (SCFAs) , which can inhibit osteoclast activity by regulating inflammatory cytokines and immune cells, promote the formation of osteoblasts and other aspects to maintain the stability of bone metabolism, and then protect the health of bones, forming a"Gut-microcology-bone"axis.
Clinical and animal studies have found that sepsis can lead to a serious imbalance in the gut microecology, a reduction in probiotics, a reduction in short-chain fatty acid, a reduction in bone mass, and an increase in bone destruction, maintaining the stability of microecology can be one of the effective means of bone protection. But at present, the treatment of sepsis with early supplementation of probiotics is still controversial, and dietary fiber intake has significantly changed the composition of the microbiota, it may be a safe and effective method to prevent bone loss in sepsis. Further study on it will provide reliable theoretical basis and intervention target for early, safe and effective prevention of osteoporosis. Therefore, based on the above research background, Investigators intend to evaluate the overall safety and efficacy of dietary fiber-containing enteral nutrition supplementation in patients with sepsis by observing changes in bone metabolism-related indicators, to provide the basis for further basic and mechanism research
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary fiber was not added to enteral nutrition preparation | – | –Dietary fiber was not added to enteral nutrition preparation |
| Dietary fiber was added to enteral nutrition preparation | – | Dietary Supplement: dietary fiber nutrientsDietary fiber was added to enteral nutrition preparation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1) sepsis 20163.0: infection + sequential organ failure assessment (Sofa) score ≥2 points. (rapid SOFA (qSOFA) scoring tool criteria: (1) respiratory frequency ≥22 beats/min; (2) change in state of consciousness; (3) systolic blood pressure ≤100 mm Hg) .
Key inclusion criteria (5 listed)
- The subjects voluntarily cooperated with the study and signed the informed consent form, and could be followed up
- Age 18-70
- It meets the diagnostic criteria of Sepsis 2016 Sepsis 3.0 guidelines
- After treatment, the Hemodynamics is stable and the patient is ready to start enteral nutrition support
- Those who need tube feeding for more than 14 days because of the need of illness and can not take food by mouth
Key exclusion criteria (6 listed)
- People who have had osteoporosis in the past
- Admission due to fracture
- The shock was not corrected, and the patients were maintained with a large amount of vaso-active drugs (0.5 ug/kg/min of noradrenaline) , but could not be given enteral nutrition
- Supplement with probiotics or prebiotics alone
- Parturients
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 |
|---|---|---|
| dietary fiber nutrientsWhether to add nutrients containing dietary fiber | Dietary supplement | Dietary fiber was added to enteral nutrition preparation |
Primary outcome
The changes of bone metabolic markers β-CTX
Time frame: 28 day
The venous blood was drawn daily before and after the enrollment (the first, third, seventh and fourteenth days) ，and β- CTX for comparison
The changes of bone metabolic markers PINP
Time frame: 28 day
9 secondary outcomes
Changes in intestinal flora
Time frame: 28 day
Changes in short-chain fatty acid of metabolites
Time frame: 28 day
Abdominal symptoms (abdominal distention)
Time frame: 28 day
Abdominal symptoms ( diarrhea incidence)
Time frame: 28 day
The change of systemic inflammatory response index: the value of TNF-α in systemic inflammatory response
Time frame: 28 day
The change of systemic inflammatory response index: the value of IL-6 in systemic inflammatory response
Time frame: 28 day
The change of systemic inflammatory response index: the value of Procalcitonin in systemic inflammatory response
Time frame: 28 day
Length of ICU stay
Time frame: 28 day
Length of Apache II score
Time frame: 28 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Zhujiang Hospital at 1 site in China.
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 5 inclusion and 6 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 21 Nov 2022. 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 China. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of bone metabolic markers β-CTX (time frame: 28 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2022.