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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Intervention Group | Experimental | Patients were randomized to receive standard nutritional support supplemented with a daily combined formulation of dietary fiber and multi-strain probiotics for 12 weeks. |
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| Active Comparator: Control Group | Active Comparator | Patients were randomized to receive standard nutritional support alone for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Dietary Fiber and Probiotics. | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Immunoglobulin A (IgA) level | Measurement of plasma IgA levels to assess humoral immune response. | Baseline and 12 weeks |
| Change in Immunoglobulin G (IgG) level | Measurement of plasma IgG levels to assess humoral immune response. | Baseline and 12 weeks |
| Change in CD4+/CD8+ T-lymphocyte ratio | Measurement of the ratio of CD4+ to CD8+ T-lymphocytes from peripheral blood to assess cellular immune status. | Baseline and 12 weeks |
| Change in Gut Microbiota Alpha Diversity | Assessment of microbial diversity within fecal samples, measured by the Shannon index based on 16S rRNA gene sequencing. | Baseline and 12 weeks |
| Change in Relative Abundance of Probiotics | Quantification of the relative abundance of key probiotic genera (Bifidobacterium, Lactobacillus) in fecal samples via 16S rRNA sequencing. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index (BMI) | Calculated as weight in kilograms divided by the square of height in meters (kg/m²). | Baseline and 12 weeks |
| Change in Patient-Generated Subjective Global Assessment (PG-SGA) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| Standard Nutritional Support | Other | This included dietary counseling from a registered dietitian and, if necessary, a standard oral nutritional supplement (Ensure®) to meet estimated energy and protein requirements. |
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A validated tool for assessing nutritional status in cancer patients, where lower scores indicate better nutritional status.
| Baseline and 12 weeks |
| Change in Quality of Life (WHOQOL-100) score | Assessed using the World Health Organization Quality of Life-100 questionnaire, with higher scores indicating better quality of life. | Baseline and 12 weeks |
| 3-Year Overall Survival Rate | Percentage of patients alive at 3 years from the date of study entry. | Up to 3 years |
| Incidence of Major Treatment-Related Complications | Number of patients experiencing grade ≥3 complications (e.g., diarrhea, neutropenic fever) during the intervention period. | During the 12-week intervention period |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D019602 |
| Food and Beverages |