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A randomized controlled clinical study of intestinal bacteria transplantation in the treatment of anal sinusitis

A randomized controlled clinical study of intestinal bacteria transplantation in the treatment of anal sinusitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091852
Enrollment
Unknown
Registered
2024-11-05
Start date
2024-11-11
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Anal sinusitis

Interventions

Control group:The clinical standard treatment was adopted, fumigation and washing with compound Jingjing fumigant twice a day. One anal Tai suppository was inserted into the anus twice a day
Levator ANI exercise: withdraw the levator ANI, first withdraw and then release, 20 times each time, 2 times a day.
Experimental Group:On the basis of standard treatment, oral intestinal bacterial transplantation (FMT) capsules were given, 15 capsules each time, once every other day, for a total of 3 times, with a

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.The clinical symptoms and signs, finger examination, and anoscopy auxiliary examination results meet the diagnostic criteria for anal sinusitis in the second edition of the "Anorectal Science of Traditional Chinese Medicine" (2012), and meet the diagnosis of damp heat bet type in the syndrome differentiation and classification criteria of traditional Chinese medicine for anal sinusitis; 2.No abnormal anal morphology or function and no anal sinusitis surgery; 3. The age at least 18 years old, not more than 65 years old, gender is not required; 4.No previous treatment with enterobacterial transplantation elsewhere; 5. Patients were informed about the content of this clinical study and voluntarily joined the trial. All patients signed the informed consent. The above conditions must be met at the same time.

Exclusion criteria

Exclusion criteria: 1.Those who cannot meet the requirements of the inclusion criteria; 2.Patients with organic diseases, hematological diseases and mental disorders; 3. Patients with other perianal diseases such as mixed hemorrhoids, anal fistula, rectal tumors, Crohn's disease, inflammatory or tuberculous lesions, perianal abscess, anorectal cancer, etc., or patients with a history of anal surgery; 4.Pregnant or lactating women; 5. Patients who could not comply with the requirements of the clinical trial, which affected the results of the trial.

Design outcomes

Primary

MeasureTime frame
Anal symptom score;

Secondary

MeasureTime frame
Number of stools;Fecal character score;Self-Rating Anxiety Scale;Self-Rating Depression Scale;

Countries

China

Contacts

Public ContactChengwei Ruan

The Affiliated Hospital of Xuzhou Medical University

doctorruan666@163.com+86 158 9527 0566

Outcome results

None listed

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