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NCT Number: NCT07194954

Dietary Fiber and Probiotics in Advanced Colorectal Cancer

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.

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Key information

Conditions

Colorectal Cancer (MSI-H) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Malnutrition Malnutrition (Calorie) Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. Change in Immunoglobulin A (IgA) level

    Time frame: Baseline and 12 weeks

    Measurement of plasma IgA levels to assess humoral immune response.

  2. Change in Immunoglobulin G (IgG) level

    Time frame: Baseline and 12 weeks

    Measurement of plasma IgG levels to assess humoral immune response.

  3. Change in CD4+/CD8+ T-lymphocyte ratio

    Time frame: Baseline and 12 weeks

    Measurement of the ratio of CD4+ to CD8+ T-lymphocytes from peripheral blood to assess cellular immune status.

  4. Change in Gut Microbiota Alpha Diversity

    Time frame: Baseline and 12 weeks

    Assessment of microbial diversity within fecal samples, measured by the Shannon index based on 16S rRNA gene sequencing.

  5. Change in Relative Abundance of Probiotics

    Time frame: Baseline and 12 weeks

    Quantification of the relative abundance of key probiotic genera (Bifidobacterium, Lactobacillus) in fecal samples via 16S rRNA sequencing.

Secondary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: Baseline and 12 weeks

    Calculated as weight in kilograms divided by the square of height in meters (kg/m²).

  2. Change in Patient-Generated Subjective Global Assessment (PG-SGA) score

    Time frame: Baseline and 12 weeks

    A validated tool for assessing nutritional status in cancer patients, where lower scores indicate better nutritional status.

  3. Change in Quality of Life (WHOQOL-100) score

    Time frame: Baseline and 12 weeks

    Assessed using the World Health Organization Quality of Life-100 questionnaire, with higher scores indicating better quality of life.

  4. 3-Year Overall Survival Rate

    Time frame: Up to 3 years

    Percentage of patients alive at 3 years from the date of study entry.

  5. Incidence of Major Treatment-Related Complications

    Time frame: During the 12-week intervention period

    Number of patients experiencing grade ≥3 complications (e.g., diarrhea, neutropenic fever) during the intervention period.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

Effects of Combined Dietary Fiber and Probiotic Supplementation on Gut Microbiota, Immune Function, and Clinical Outcomes in Patients With Advanced Colorectal Cancer: A Prospective Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 26, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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