Colorectal Cancer (MSI-H), Malnutrition (Calorie)
Conditions
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTCombined Dietary Fiber and Probiotics.
The intervention consisted of a daily oral administration of 20g of a mixed dietary fiber powder (FibroBalance®, containing inulin, pectin, and β-glucan) and one multi-strain probiotic capsule (ProbioCare Forte®, delivering 10\^9 CFU of Lactobacillus acidophilus NCFM, Bifidobacterium lactis Bi-07, and Streptococcus thermophilus St-21).
OTHERStandard Nutritional Support
This included dietary counseling from a registered dietitian and, if necessary, a standard oral nutritional supplement (Ensure®) to meet estimated energy and protein requirements.
Sponsors
The First Hospital of Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Relative Abundance of Probiotics | Baseline and 12 weeks | Quantification of the relative abundance of key probiotic genera (Bifidobacterium, Lactobacillus) in fecal samples via 16S rRNA sequencing. |
| Change in Immunoglobulin A (IgA) level | Baseline and 12 weeks | Measurement of plasma IgA levels to assess humoral immune response. |
| Change in Immunoglobulin G (IgG) level | Baseline and 12 weeks | Measurement of plasma IgG levels to assess humoral immune response. |
| Change in CD4+/CD8+ T-lymphocyte ratio | Baseline and 12 weeks | Measurement of the ratio of CD4+ to CD8+ T-lymphocytes from peripheral blood to assess cellular immune status. |
| Change in Gut Microbiota Alpha Diversity | Baseline and 12 weeks | Assessment of microbial diversity within fecal samples, measured by the Shannon index based on 16S rRNA gene sequencing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | Baseline and 12 weeks | Calculated as weight in kilograms divided by the square of height in meters (kg/m²). |
| Change in Patient-Generated Subjective Global Assessment (PG-SGA) score | Baseline and 12 weeks | A validated tool for assessing nutritional status in cancer patients, where lower scores indicate better nutritional status. |
| Change in Quality of Life (WHOQOL-100) score | Baseline and 12 weeks | Assessed using the World Health Organization Quality of Life-100 questionnaire, with higher scores indicating better quality of life. |
| 3-Year Overall Survival Rate | Up to 3 years | Percentage of patients alive at 3 years from the date of study entry. |
| Incidence of Major Treatment-Related Complications | During the 12-week intervention period | Number of patients experiencing grade ≥3 complications (e.g., diarrhea, neutropenic fever) during the intervention period. |
Countries
China
Outcome results
None listed