Dietary Fiber and Probiotics in Advanced Colorectal Cancer

Hebei Medical University

Status: Completed

Conditions: Colorectal Cancer (MSI-H); Malnutrition (Calorie)

Treatments: Other: Standard Nutritional Support; Dietary Supplement: Combined Dietary Fiber and Probiotics.

Study type: Interventional

Funder types: Other

Identifiers

NCT07194954

2022S00116

Details and patient eligibility

About

This single-center, prospective, randomized controlled trial was conducted to evaluate the efficacy of a 12-week combined dietary fiber and probiotic supplementation on gut microbiota, immune function, nutritional status, and survival outcomes in malnourished patients with advanced colorectal cancer undergoing conventional therapy, compared to standard nutritional support alone.

Full description

Patients with advanced colorectal cancer often suffer from malnutrition and immune suppression, which can negatively impact treatment outcomes. This study investigated whether modulating the gut microbiota could improve clinical outcomes. A total of 80 eligible patients were randomly assigned in a 1:1 ratio to an intervention group or a control group. The intervention group (n=40) received standard nutritional support plus a daily supplement of mixed dietary fiber and multi-strain probiotics for 12 weeks. The control group (n=40) received standard nutritional support alone. Key endpoints, including immune markers (IgA, IgG, CD4+/CD8+ ratio), gut microbiota composition (16S rRNA sequencing), nutritional status (BMI, PG-SGA), and quality of life (WHOQOL-100), were assessed at baseline and after 12 weeks. Survival was monitored for 18 months to determine the impact on short-term prognosis.

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed diagnosis of stage II-IV colorectal cancer post-resection.
• Receiving active adjuvant chemotherapy.
• Documented moderate-to-severe malnutrition (PG-SGA score ≥ 4).
• Ability to tolerate oral intake.
• Voluntarily signed the informed consent form.

Exclusion criteria

• Presence of complete bowel obstruction.
• Severe, uncontrolled organ dysfunction (cardiac, hepatic, renal).
• Known allergy to any component of the nutritional supplements.
• Concurrent participation in another interventional trial.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Experimental: Intervention Group

Experimental group

Description:

Patients were randomized to receive standard nutritional support supplemented with a daily combined formulation of dietary fiber and multi-strain probiotics for 12 weeks.

Treatment:

Dietary Supplement: Combined Dietary Fiber and Probiotics.

Active Comparator: Control Group

Active Comparator group

Description:

Patients were randomized to receive standard nutritional support alone for 12 weeks.

Treatment:

Other: Standard Nutritional Support