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Clinical ntrition intervention of Novasource GI Control in patients after gastrointestinal surgery: a prospective, multicenter, open, non-inferiority, randomized, placebo-controlled trial

Clinical ntrition intervention of Novasource GI Control in patients after gastrointestinal surgery: a prospective, multicenter, open, non-inferiority, randomized, placebo-controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038429
Enrollment
Unknown
Registered
2020-09-22
Start date
2020-10-01
Completion date
Unknown
Last updated
2022-03-07

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

Conditions

Patients requiring enteral nutritional support after gastrointestinal surgery

Interventions

Group 1:NSGI
Group 2:Nutrison

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients requiring enteral nutrition support after gastrointestinal surgery; 2. Aged 18-75 years; 3. BMI 18.5-28.0 kg/m2 at admission; 4. Apache-II score = 7 days; 6. The informed consent is signed, and the questionnaire survey and follow-up need to be completed as required.

Exclusion criteria

Exclusion criteria: 1. Unable to establish enteral nutritional pathways; 2. Patients with enteral nutrition contraindications such as hemodynamic instability, gastrointestinal bleeding, postoperative acute pancreatitis, inflammatory bowel disease (Crohn's disease or ulcerative colitis), intestinal ischemia, persistent intestinal obstruction, intestinal paralysis, high flow intestinal fistula and inability to establish distal access; 3. The presence of infectious diarrhea; 4. Bone marrow or organ transplant patients; 5. Other patients with leukopenia, neutropenia, malignant blood diseases, HIV and other diseases are considered not suitable to participate in this study clinically; 6. Patients with renal insufficiency (eGFR < 60mL/min) or in need of dialysis treatment; 7. Abnormal thyroid function; 8. The patient, legal representative or guardian refuses to participate in the study; 9. Pregnant or lactating female patients; 10. Known to be allergic to any of the ingredients in the study or control product, or determined by the investigator to require dietary fiber restriction; 11. Galactosemia; 12. Expected survival <= 10 days.

Design outcomes

Primary

MeasureTime frame
the proportion of patients with diarrhea >=1 day;

Secondary

MeasureTime frame
The proportion of diarrhea days in the total feeding days;the proportion of patients with constipation;the proportion of patients with abdominal distension;the proportion of patients with Nausea or vomiting;change of body weight and BMI;Changes of prealbumin level before and after 5 days of enteral nutrition support after gastrointestinal surgery;Fasting blood glucose after gastrointestinal surgery;Total intake of enteral nutrient solution and total energy intake per day;Length and total costs in hospital stay;Quality of life;Number of rehospitalizations within 30 days of discharge;Changes in gut microbiota;

Countries

China

Contacts

Public ContactTing Han

Shanghai Tenth People's Hospital

253255849@qq.com+86 13817178163

Outcome results

None listed

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