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Synbiotics and Post-Intensive Care Syndrome in Sepsis Patients

A study on the effects of synbiotic supplementation on post-intensive care syndrome in patients with sepsis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1060250008
Enrollment
780
Registered
2025-04-28
Start date
2025-04-28
Completion date
Unknown
Last updated
2025-07-18

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

Conditions

sepsis sepsis

Interventions

Administer a synbiotic product to the patient

Sponsors

Saijo Saki
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients diagnosed with sepsis and admitted to the ICU, in whom enteral nutrition was initiated within 24 hours of ICU admission

Exclusion criteria

Exclusion criteria: Patients who died within 24 hours after ICU admission Pregnant or breastfeeding women Patients with conditions that contraindicate enteral nutrition (intestinal obstruction, gastrointestinal perforation) Patients who had been continuously using synbiotic products prior to the study Patients with a known allergy to synbiotic products If the patient (or their legal representative) refuses to participate in the study

Design outcomes

Primary

MeasureTime frame
Incidence of post-intensive care syndrome (PICS) within 30 days after ICU discharge, including physical, cognitive, and psychological impairments

Secondary

MeasureTime frame
Severity of post-intensive care syndrome (PICS) Length of ICU stay Length of hospital stay 28-day mortality rate Incidence of infections (e.g., ventilator-associated pneumonia [VAP], catheter-related bloodstream infection [CRBSI], urinary tract infection) Duration of antibiotic use Gastric residual volume Bowel conditions (frequency and amount of defecation, stool characteristics) Changes in blood inflammatory markers (e.g., C-reactive protein [CRP])

Contacts

Public ContactSaki Saijo

Tokushima University Graduate School

saki.saijo@tokushima-u.ac.jp+81-70-6586-0442

Outcome results

None listed

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