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A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Probiotics and Prebiotics on Postoperative Defecation Following haemorrhoidectomy"

A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Probiotics and Prebiotics on Postoperative Defecation Following haemorrhoidectomy" - ProPre on Post-Hemorrhoidectomy Defecation: Multi-center RCT.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115001
Enrollment
Unknown
Registered
2025-12-19
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Haemorrhoids

Interventions

Trial group:Probiotic preparations and probiotic products were taken. Probiotics were bifidobacteria triple live enteric capsules with main components including bifidobacteria, Lactobacillus acidophil
probiotics were inulin 50g/ time, twice a day.
Control group:Take a placebo capsule composed of vitamin C and maltodextrin powder, vitamin C capsule, orally, 2 times a day, maltodextrin powder, 50g/ time, 2 times a day

Sponsors

Shenzhen Guangming District People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients aged 18-50 years old, grade II-IV patients, no more than 4 hemorrhoidectomy, internal hemorrhoidal ligation no more than 3.

Exclusion criteria

Exclusion criteria: 1. Severe circular hemorrhoids incarcerated, more than 4 hemorrhoidal nuclei removed; 2. History of inflammatory bowel disease; 3. Have been diagnosed with diseases that affect bowel movements, such as intractable constipation, constipated irritable bowel syndrome, and diarrheal irritable bowel syndrome; 4. Allergic to probiotic samples or ingredients; 5. Use of antibiotics or probiotics in the past 1 month; 6. Use of anti-anxiety, antidepressant or other psychotropic drugs in the past month; 7. Long-term use of constipation medications; 8. Chronic diseases of the kidney, liver, gastrointestinal tract, lungs or endocrine system; 9. Serious diseases such as type I or type II diabetes mellitus, myocardial infarction, cerebral infarction, malignant neoplasm and immunodeficiency diseases; 10. Patients who are being treated for gastrointestinal disorders that may affect intestinal function; 11. Use of foods, supplements or drugs that affect bowel function; 12. A person who is pregnant, breastfeeding or may become pregnant; 13. Persons who are illiterate, unable to understand the informed consent form or independently sign the informed consent form, or who have difficulty filling out various questionnaires; 14. Other patients who have been determined by the physician to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Frequency of bowel movements (times/week);Defecation trait;Bowel pain score(Visual Analogue Scale/Score);Anal distention distress score;

Secondary

MeasureTime frame
ncidence of postoperative major bleeding;

Countries

China

Contacts

Public ContactLu Ruimin

Shenzhen Guangming District People's Hospital

925491765@qq.com+86 150 1949 7212

Outcome results

None listed

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