Clinical trial NCT05623098: Effects of Dietary Fiber on Bone Metabolism
Official title: Effects of Dietary Fiber Enteral Nutrition on Bone Metabolism in Septic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: short-chain fatty acid
sepsis
bone metabolism
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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) .

Brief 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 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

Eligibility criteria: Inclusion Criteria:

1. The subjects voluntarily cooperated with the study and signed the informed consent form, and could be followed up
2. Age 18-70
3. It meets the diagnostic criteria of Sepsis 2016 Sepsis 3.0 guidelines
4. After treatment, the Hemodynamics is stable and the patient is ready to start enteral nutrition support
5. Those who need tube feeding for more than 14 days because of the need of illness and can not take food by mouth

Exclusion Criteria:

1. People who have had osteoporosis in the past
2. Admission due to fracture
3. 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
4. Supplement with probiotics or prebiotics alone
5. Parturients
6. No written informed consent

Primary outcomes:
measure: The changes of bone metabolic markers β-CTX
timeFrame: 28 day
measure: The changes of bone metabolic markers PINP
timeFrame: 28 day
Secondary outcomes:
measure: Changes in intestinal flora
timeFrame: 28 day
measure: Changes in short-chain fatty acid of metabolites
timeFrame: 28 day
measure: Abdominal symptoms (abdominal distention)
timeFrame: 28 day
measure: Abdominal symptoms ( diarrhea incidence)
timeFrame: 28 day
measure: The change of systemic inflammatory response index: the value of TNF-α in systemic inflammatory response
timeFrame: 28 day
measure: The change of systemic inflammatory response index: the value of IL-6 in systemic inflammatory response
timeFrame: 28 day
measure: The change of systemic inflammatory response index: the value of Procalcitonin in systemic inflammatory response
timeFrame: 28 day
measure: Length of ICU stay
timeFrame: 28 day
measure: Length of Apache II score
timeFrame: 28 day
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang hospital
state: Guangdong
Study officials:
References: