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Effects of Dietary Fiber on Bone Metabolism

Z

Zhujiang Hospital

Status

Active, not recruiting

Conditions

Sepsis

Treatments

Dietary Supplement: dietary fiber nutrients

Study type

Observational

Funder types

Other

Identifiers

NCT05623098
2022LX0036_GC

Details and patient eligibility

About

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.

Full 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

Enrollment

2 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

2 participants in 2 patient groups

Dietary fiber was not added to enteral nutrition preparation
Description:
Dietary fiber was not added to enteral nutrition preparation
Dietary fiber was added to enteral nutrition preparation
Description:
Dietary fiber was added to enteral nutrition preparation
Treatment:
Dietary Supplement: dietary fiber nutrients

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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