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A Randomized Controlled Trial Investigating the Impact of Colon-Specific Probiotic Delivery Technology on Gastrointestinal Function and Gut Microbiota in Stroke Patients

A Randomized Controlled Trial Investigating the Impact of Colon-Specific Probiotic Delivery Technology on Gastrointestinal Function and Gut Microbiota in Stroke Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084918
Enrollment
Unknown
Registered
2024-05-28
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

Stroke

Interventions

Control group:The same probiotic compound administered via a nasogastric tube using conventional delivery techniques at 4 times daily doses of 20-40mg per dose, with a maximum of up to 80mg per dose i
Colonic Targeted Delivery Group:Probiotic compound preparation delivered through a nasogastric tube using colon-targeted delivery technology (probiotic compound formulation that remains structurally s

Sponsors

Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.According to the guidelines for the management of spontaneous intracerebral hemorrhage, the management guidelines for acute ischemic stroke, and the CT imaging diagnosis for stroke, 2. GCS score = 8 3. Age between 18 and 80, any gender 4. Individuals without legal capacity will have their participation determined by a legal representative, who will sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. After cardiopulmonary resuscitation or brain death (brain death criteria based on Determination of Brain Death/Death by Neurologic Criteria). 2. Previous or pre-existing history of gastrointestinal surgery, or experiencing gastrointestinal complications (intestinal obstruction, gastrointestinal bleeding). 3. Hemodynamic instability (norepinephrine >0.5ug/kg/min, according to Surviving sepsis campaign: international guidelines for management of sepsis). 4.Broad-spectrum antibiotics (cephalosporins of the fourth generation or above, or combination therapy) are required upon admission.

Design outcomes

Primary

MeasureTime frame
The percentage of Bristol Stool Chart types 3-5;

Secondary

MeasureTime frame
Bowel movements frequency;Incidence of gastrointestinal complications;Gut microbiota diversity;Intestinal Flora Metabolites;ICU hospitalization time;14 days survival rate;60 days survival rate;

Countries

China

Contacts

Public ContactMingli Zhu

Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital.

ate_ate@163.com+86 137 0190 3155

Outcome results

None listed

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