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Research on the Regulation of Intestinal Immune Microecology to Reduce Postoperative Complications Following Hirschsprung's Disease

Research on the Regulation of Intestinal Immune Microecology to Reduce Postoperative Complications Following Hirschsprung's Disease - PMI-HD RCT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129694
Enrollment
Unknown
Registered
2026-08-07
Start date
2025-12-02
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Hirschsprung disease

Interventions

Intervention group:Routine perioperative management plus perioperative microecological combined intervention, including live combined Bifidobacterium-Lactobacillus tablets, Clostridium butyricum powde
Control group:Routine perioperative management, including preoperative bowel preparation, perioperative antibiotic-based treatment, anesthesia and surgical management, intravenous nutritional support,

Sponsors

shanghai Children’s Medical Center Guizhou Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.2 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1.Definitive diagnosis: The patient must have a confirmed diagnosis of Hirschsprung's disease established by a physician. 2.Age range: Participants must be within a specified age range (e.g., >1 year of age) to ensure homogeneity of the study population. 3.Surgical plan: The patient must have a clear surgical plan and be scheduled to undergo surgery in the near future. 4.Parental/guardian consent: Written informed consent must be obtained from the parent or legal guardian of all children to allow participation in this study. For children over 8 years of age, the child's own assent must also be obtained, and the child must sign the informed consent form. Written informed consent obtained from the guardians.

Exclusion criteria

Exclusion criteria: 1.Other serious diseases: Patients with other serious diseases besides Hirschsprung's disease, such as congenital heart disease or immune system disorders, which may 2.Prior treatment: Patients who have received treatments that may affect the gut microbiota or immune system within the recent period. 3.Inability to comply with the study: Parents or guardians who are unable or unwilling to cooperate with study requirements, such as sample collection and data recording. 4.Known allergy to study drugs or treatments: If the study involves specific drugs or therapies, patients with known allergies to these drugs or therapies will be excluded.

Design outcomes

Primary

MeasureTime frame
Incidence of Hirschsprung-associated enterocolitis within 6 months after surgery;Changes in gut microbiota diversity and relative abundance of major genera;

Secondary

MeasureTime frame
Length of postoperative hospital stay;Changes in perioperative inflammatory and immune indices;

Countries

China

Contacts

Public ContactZhuang Yize

shanghai Children’s Medical Center Guizhou Hospital, Shanghai Jiao Tong University School of Medicine

853144755@qq.com+86 187 8512 2823

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026