Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05623098
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-11-21
First Post:
2022-08-31
Brief Title:
Effects of Dietary Fiber on Bone Metabolism
Sponsor:
Zhujiang Hospital
Organization:
Zhujiang Hospital
Study Overview
Official Title:
Effects of Dietary Fiber Enteral Nutrition on Bone Metabolism in Septic Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 theInvisible killerof 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 theInitiating organandCentral organ of multiple organ dysfunction and forms a complex and powerfulGut-bone axiswith 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 aGut-microcology-boneaxis
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None