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Effect of prebiotics in regulating gut microbiota of patients with colorectal cancer on the prognosis of fluorouracil treatment

Effect of prebiotics in regulating gut microbiota of patients with colorectal cancer on the prognosis of fluorouracil treatment

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046237
Enrollment
Unknown
Registered
2021-05-12
Start date
2021-05-11
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Colorectal cancer

Interventions

Experimental group:Volunteers in Xylooligosaccharide group received Xylooligosaccharide 3 g/d in addition to standard capecitabine combined with oxaliplatin adjuvant chemotherapy.
Control group:The blank control group received no additional nutritional intervention on the basis of standard capecitabine combined with oxaliplatin adjuvant chemotherapy.

Sponsors

The Affiliated Hospital of Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with primary colorectal cancer should receive and tolerate capecitabine combined with oxaliplatin (XELOX) chemotherapy after radical resection of primary tumor; Patients with unresectable or unresectable colorectal tumors should receive and tolerate chemotherapy with the XELOX regimen; 2. Aged 18 to 80 years; 3. The Eastern Cooperative Oncology Group (ECOG) physical status score was 0 or 1(KPS>= 70%), absolute number of neutrophils (ANC) >=1.5x10^9/L, platelet >=100x10^9/L, Serum creatinine <=1.5 times of ULN (upper limit of normal), total bilirubin <=1.5 times of ULN (upper limit of normal), AST/ALT<=2.5 times of ULN (upper limit of normal), carcinoembryo antigen within the normal range; 4. Patients who received primary tumor radical surgery did not receive preoperative neoadjuvant radiotherapy or chemical therapy; 5. Complete follow-up data; 6. Han people, who have lived in the local area for at least 5 years and have a fixed residence.

Exclusion criteria

Exclusion criteria: 1. Suffer from other tumors simultaneously; 2. Patients had other digestive tract diseases except digestive tract tumor, such as inflammatory bowel disease, acute gastroenteritis, etc.; 3. Take antibiotics or probiotic-containing drugs or foods within 2 weeks; 4. Patients with active infection or mental illness, cardiovascular and cerebrovascular diseases, severe cardiopulmonary dysfunction and other serious diseases are not suitable for chemotherapy; 5. Patients with previous multicourse chemotherapy, large area radiotherapy, advanced age, bone marrow metastasis, severe infection, adrenal insufficiency, or severe disease; 6. Pregnant women; 7. The patient cannot receive treatment on time and cannot fully cooperate.

Design outcomes

Primary

MeasureTime frame
Intestinal flora sequencing;Blood concentration;Toxic and side effects of chemotherapy;Quality of life;

Secondary

MeasureTime frame
Chemotherapeutic effect;Five-year survival rate;

Countries

China

Contacts

Public ContactZhang Feng

The Affiliated Hospital of Jiangnan University

zf9958@163.com+86 15301516836

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026