Dietary Fiber and Probiotics in Advanced Colorectal Cancer

NCT07194954 | Completed

• 1 other identifier: 2022S00116
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (5)

• Change in Body Mass Index (BMI)

  Baseline and 12 weeks

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

  Baseline and 12 weeks

• Change in Quality of Life (WHOQOL-100) score

  Baseline and 12 weeks

• 3-Year Overall Survival Rate

  Up to 3 years

• Incidence of Major Treatment-Related Complications

  During the 12-week intervention period

Study Arms (2)

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.

Dietary Supplement: Combined Dietary Fiber and Probiotics.

Active Comparator: Control Group

ACTIVE COMPARATOR

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

Other: Standard Nutritional Support

Interventions

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).

Experimental: Intervention Group

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.

Active Comparator: Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Malnutrition

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 26, 2025
• Study Start: May 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2024
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

CN (1)