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Effect of galactomannan (PHGG)-enriched enteral formula on GI tolerance and gut microbiota for critical ill patients

Effect of galactomannan (PHGG)-enriched enteral formula on GI tolerance and gut microbiota for critical ill patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041789
Enrollment
Unknown
Registered
2021-01-05
Start date
2020-12-29
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

Critical illness

Interventions

Trial group:NSGI

Sponsors

Ruijin Northern Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

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) x 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. BMI 30 kg/m2; 2. Enteral nutrition products containing dietary fiber and whole nutrient were received within 24 hours before ICU admission; 3. Expected stay in ICU < 10 days; 4. Patients with known presence of inflammatory bowel disease (Crohn's disease or ulcerative colitis); 5. Patients who are undergoing chemotherapy and radiation; 6. Patients who recieved bone marrow or organ transplant; 7. HIV positivity; 8. Pregnant or lactating woman; 9. A history of galactosemia; 10. 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; 11. Other patients considered not suitable for this study by researchers.

Design outcomes

Primary

MeasureTime frame
Targeted feeding rate;

Secondary

MeasureTime frame
The proportion of patients with gastrointestinal intolerance;Blood glucose during ICU stay;Changes of prealbumin on the day of admission, before and after 5, 10 days of enteral nutrition support;Rate of ventilator-associated pneumonia during ICU stay;Rate of catheter-related bloodstream infection during ICU stay;Rate of gastrointestinal stress ulcer bleeding during ICU stay;Usage of parenteral nutrition;28 days mortality after ICU admission;Length of hospital stay;Length of ICU stay;Length of mechanical ventilation;SOFA and APECHE-II;Changes in gut microbiota;

Countries

China

Contacts

Public ContactChen Dechang

Ruijin Northern Hospital Affiliated to Shanghai Jiaotong University School of Medicine

15168887139@163.com+86 18918520002

Outcome results

None listed

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