Children with medical complexity who are scheduled to undergo gastrostomy, fundoplication, or trache dysbiosis
Conditions
Interventions
Participants will be instructed to take Symprotec (the investigational food).
The administration period will be 2 to 4 weeks.
One dose consists of one packet of Symprotec powder (containing live Lacto
Sponsors
Kawaguchi Yunosuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Patients must meet all of the following conditions. 1) Patients with severe motor and intellectual disabilities (criteria described below) as an underlying condition. 2) Patients undergoing gastrostomy placement, fundoplication, or tracheostomy. 3) Patients receiving tube feeding. 4) Patients aged 3 years or older at the time of obtaining consent. 5) Patients (or their legally authorized representatives) who have received a sufficient explanation regarding participation in this study, fully understood the content, and provided voluntary written informed consent.
Exclusion criteria
Exclusion criteria: Participants who meet any of the following conditions will be excluded from the study: 1. Patients whose primary nutrition consists of oral meals or paste meals (including blenderized diets). 2. Patients who have changed their method of nutritional administration within 2 weeks prior to the start of the investigational product. 3. Patients who have changed the type of probiotics administered within 2 weeks prior to the start of the investigational product. 4. Patients who have received therapeutic-dose antibiotics within 2 weeks prior to the start of the investigational product. 5. Patients with renal impairment (creatinine clearance < 30 mL/min, or estimated GFR by creatinine or cystatin C < 30 mL/min/1.73 m2, calculated using predictive equations). 6. Patients with a history of hypersensitivity to Lactobacillus casei strain Shirota, Bifidobacterium strains, or galacto-oligosaccharides. 7. Patients with hypersensitivity to probiotics or other components included in the investigational product. 8. Patients with milk allergy. 9. Any other patient deemed unsuitable for safe participation in this study by the principal investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in gut microbiota alpha diversity from pre administration (Day 1) to post administration (Day 14-28), | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in gut microbiota alpha diversity from post administration (Day 14-28) to the preoperative period, and from pre administration to the preoperative period. 2) Change in the relative abundance of Bifidobacteriaceae in the gut microbiota from pre-administration (Day 1) to post administration (Day 14-28), from post-administration (Day 14-28) to the preoperative period, and from pre-administration (Day 1) to the preoperative period. 3) Incidence and severity of postoperative complications, including wound infection, aspiration pneumonia, atelectasis, duration of postoperative fever, peristomal leakage, and dumping syndrome. 4) Absolute white blood cell (WBC) count, C reactive protein (CRP) level, and neutrophil-to-lymphocyte ratio (NLR) at pre-administration, post-administration, and preoperative timepoints. 5) Changes in weekly average stool frequency and stool consistency from pre-administration to post-administration. Secondary safety outcome Incidence and severity of adverse events | — |
Contacts
Public ContactYuunosuke Kawaguchi
Chiba University Hospital
Outcome results
None listed