Skip to content

A clinical study of probiotics combined with prebiotics to improve the perioperative prognosis of patients with rectal cancer with neoadjuvant chemotherapy

A clinical study of probiotics combined with prebiotics to improve the perioperative prognosis of patients with rectal cancer with neoadjuvant chemotherapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118436
Enrollment
Unknown
Registered
2026-02-05
Start date
2024-10-10
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Rectal cancer

Interventions

intervention group:Oral probiotics (Clostridium butyricum live bacteria capsules, 1260 mg per dose, twice daily) and prebiotics (inulin rich in fructooligosaccharides, 6 g per dose, once daily)
Control group:Placebo of equivalent dosage

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Voluntarily participates in the study and signs the informed consent form; 2.Diagnosed with colorectal cancer through colonoscopy and pathological examination; 3.In generally good health, aged between 18 and 75 years; 4.No evidence of distant metastasis; 5.No severe dysfunction of the heart, lungs, kidneys, or liver prior to surgery; 6.Has completed at least four cycles of neoadjuvant chemotherapy with either the FOLFOX or XELOX regimen.

Exclusion criteria

Exclusion criteria: 1.Use of any antibiotics within one week prior to enrollment; 2.Presence of malignant tumors in other sites or a history of malignancy; 3.Presence of metabolic diseases such as obesity, diabetes, or various liver diseases; 4.Family history of clustered cases; 5.Incomplete clinical data that cannot be retrieved.

Design outcomes

Primary

MeasureTime frame
Incidence rate of infections within one month after surgery;

Secondary

MeasureTime frame
Inflammatory markers within 30 days after surgery;Comparison of postoperative adverse events evaluated by Clavien–Dindo classification at 7 and 30 days;

Countries

China

Contacts

Public ContactXiaorong Deng

The Second Affiliated Hospital of Nanchang University

dengxr77@163.com+86 183 1803 0773

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026