Dietary Fiber and Probiotics in Advanced Colorectal Cancer
NCT ID: NCT07194954
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2022-05-01
2024-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Experimental: Intervention Group
Patients were randomized to receive standard nutritional support supplemented with a daily combined formulation of dietary fiber and multi-strain probiotics for 12 weeks.
Combined 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).
Active Comparator: Control Group
Patients were randomized to receive standard nutritional support alone for 12 weeks.
Standard 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.
Interventions
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Combined 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).
Standard 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe, uncontrolled organ dysfunction (cardiac, hepatic, renal).
* Known allergy to any component of the nutritional supplements.
* Concurrent participation in another interventional trial.
18 Years
75 Years
ALL
No
Sponsors
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The First Hospital of Hebei Medical University
OTHER
Responsible Party
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Feifei Wang
Principal Investigator
Locations
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First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Countries
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Other Identifiers
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2022S00116
Identifier Type: -
Identifier Source: org_study_id
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