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Preliminary study on anal function and wound healing in infants after anal fistula surgery with the method of replenishing Qi and strengthening the spleen based on gut microbiota

Preliminary study on anal function and wound healing in infants after anal fistula surgery with the method of replenishing Qi and strengthening the spleen based on gut microbiota

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070162
Enrollment
Unknown
Registered
2023-04-04
Start date
2023-04-05
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Infantile Anal fistula

Interventions

Traditional Chinese medicine group:Routine treatment after surgery and Shenlingjianpi prescription
Control group:Routine treatment after surgery

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged between 28 days and 3 years old; 2. Patients should meet diagnostic criteria for low anal fistula defined by The Guidelines for Diagnosis and Treatment of Common Diseases of Coloproctology in Traditional Chinese Medicine established by the China Association of Chinese Medicine; 3. Willing to receive traditional Chinese medicine.

Exclusion criteria

Exclusion criteria: 1. Patients have the severe underlying disease of inflammatory bowel disease, necrotizing enterocolitis, leukemia, hidradenitis suppurativa, cellulitis, anorectal malformations, etc.; 2. Those who are undergoing other clinical trials and taking medication; 3. Patients have received any antibiotics within 3 months and probiotics within 1 week before their samples are taken; 4. Unwilling to receive traditional Chinese medicine.

Design outcomes

Primary

MeasureTime frame
Anal function;Wound healing performance;

Secondary

MeasureTime frame
Defecation frequency;Stool consistency;TCM syndrome score;Anorectal manometry;Gut microbiota;

Countries

China

Contacts

Public ContactLu Jingen

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

jingen.lu@shutcm.edu.cn+8618117285738

Outcome results

None listed

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