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Effect on multiple organ function for patients with critical brain injury via gut microbiota regulation

Effect on multiple organ function for patients with critical brain injury via gut microbiota regulation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036916
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical brain injury

Interventions

Trial group 1:PHGG
Trial group 2:PHGG+Lostridium Butyricum
Trial group 3:TP+Lostridium Butyricum

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. ICU patients who meet the definition of critical brain injury, and expected to stay in ICU >=12 days; 2. 18-80 years old (including boundary value); 3. AGI grade I or II at ICU admission; 4. Hemodynamic stability: 1) Mean arterial pressure MAP (mean arterial pressure) >= 65 mmHg; 2) No vasoactive drugs or low-dose vasoactive drugs: norepinephrine <0.5µg/kg/min, dopamine infusion < 5µg/kg/ min (or norepinephrine equivalent price formula: (norepinephrine <12.5µg/ min = [norepinephrine (µg/ min)) + [dopamine (µg/ kg / min) ÷ 2] + [adrenal gland (Mg/min)] + [Phenylephrine (µg/min)÷10] + [vasopressin (Unit/h)×8.33]); 5. Unable to eat through the mouth, and initiating total nutritional enteral nutrition support is required and a nasointestinal or nasogastric tube can be safely established; 6. The informed consent is signed, and the questionnaire survey and follow-up need to be completed as required.

Exclusion criteria

Exclusion criteria: 1. Enteral nutrition products containing dietary fiber and whole nutrient were received within 24 hours before ICU admission; 2. Patients with known presence of inflammatory bowel disease (Crohn's disease or ulcerative colitis); 3. Patients who are undergoing chemotherapy and radiation; 4. Patients who recieved bone marrow or organ transplant; 5. HIV positivity; 6. Pregnant or lactating woman; 7. A history of galactosemia; 8. Patients who are known to be allergic to any of the ingredients in the test products or who have been identified by researchers as needing to limit their dietary fiber intake; 9. Other patients considered not suitable for this study by researchers.

Design outcomes

Primary

MeasureTime frame
Changes in gut microbiota;Organ function evaluation;

Secondary

MeasureTime frame
Targeted feeding rate;Blood glucose during ICU stay;Changes of hemoglobin, prealbumin, and quadriceps femoris thickness (QMLT) before and after 10 days of enteral nutrition support;28 days mortality after ICU admission;Length of hospital stay;Length of hospital stay;Length of ICU stay;Inflammation levels;

Countries

China

Contacts

Public ContactTan Jiaying

Huashan Hospital, Fudan University

tanjiaying@huashan.org.cn+86 13761519057

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026