An interventional study of Combined Dietary Fiber and Probiotics. and Standard Nutritional Support in Colorectal Cancer (MSI-H) and Malnutrition (Calorie), sponsored by The First Hospital of Hebei Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by The First Hospital of Hebei Medical University · Not applicable, Interventional, and Supportive care
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.
5,600 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 80 is close to the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →The First Hospital of Hebei Medical University is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Patients were randomized to receive standard nutritional support supplemented with a daily combined formulation of dietary fiber and multi-strain probiotics for 12 weeks.
Dietary Supplement: Combined Dietary Fiber and Probiotics.
Patients were randomized to receive standard nutritional support alone for 12 weeks.
Other: Standard Nutritional Support
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).
This included dietary counseling from a registered dietitian and, if necessary, a standard oral nutritional supplement (Ensure®) to meet estimated energy and protein requirements.
Change in Immunoglobulin A (IgA) level
Measurement of plasma IgA levels to assess humoral immune response.
Time frame: Baseline and 12 weeks
Change in Immunoglobulin G (IgG) level
Measurement of plasma IgG levels to assess humoral immune response.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 weeks
Change in Body Mass Index (BMI)
Calculated as weight in kilograms divided by the square of height in meters (kg/m²).
Time frame: Baseline and 12 weeks
Change in Patient-Generated Subjective Global Assessment (PG-SGA) score
A validated tool for assessing nutritional status in cancer patients, where lower scores indicate better nutritional status.
Time frame: 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.
Time frame: Baseline and 12 weeks
3-Year Overall Survival Rate
Percentage of patients alive at 3 years from the date of study entry.
Time frame: 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.
Time frame: During the 12-week intervention period
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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The First Hospital of Hebei Medical University