Colorectal Cancer (MSI-H)NCT07194954
Dietary Fiber and Probiotics in Advanced Colorectal Cancer
A study testing Combined Dietary Fiber and Probiotics. and Standard Nutritional Support in people with Colorectal Cancer (MSI-H) and Malnutrition (Calorie), run by The First Hospital of Hebei Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer (MSI-H), Malnutrition (Calorie)
- What is being tested?
- Combined Dietary Fiber and Probiotics. and Standard Nutritional Support
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer (MSI-H), Malnutrition (Calorie)
- Being tested
- Combined Dietary Fiber and Probiotics., Standard Nutritional Support
- Medical subject headings
- Colorectal Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 SupportOther
This included dietary counseling from a registered dietitian and, if necessary, a standard oral nutritional supplement (Ensure®) to meet estimated energy and protein requirements.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Nutritional Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Immunoglobulin A (IgA) level
Measurement of plasma IgA levels to assess humoral immune response.
Measured: Baseline and 12 weeks
Change in Immunoglobulin G (IgG) level
Measurement of plasma IgG levels to assess humoral immune response.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
Secondary outcomes (5)
Change in Body Mass Index (BMI)
Calculated as weight in kilograms divided by the square of height in meters (kg/m²).
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks
3-Year Overall Survival Rate
Percentage of patients alive at 3 years from the date of study entry.
Measured: 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.
Measured: During the 12-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 May 2022
- Primary completion1 Mar 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (MSI-H)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feifei Wang, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194954
- Sponsor's protocol ID
- 2022S00116
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07194954
- Acronym / sponsor ID
- 2022S00116
- Conditions
- Colorectal Cancer (MSI-H), Malnutrition (Calorie)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention Group | Experimental | Dietary Supplement: Combined Dietary Fiber and Probiotics.Patients were randomized to receive standard nutritional support supplemented with a daily combined formulation of dietary fiber and multi-strain probiotics for 12 weeks. |
| Active Comparator: Control Group | Active comparator | Other: Standard Nutritional SupportPatients were randomized to receive standard nutritional support alone for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Dietary supplement | Experimental: Intervention Group |
| Standard Nutritional SupportThis included dietary counseling from a registered dietitian and, if necessary, a standard oral nutritional supplement (Ensure®) to meet estimated energy and protein requirements. | Other | Active Comparator: Control Group |
Primary outcome
Change in Immunoglobulin A (IgA) level
Time frame: Baseline and 12 weeks
Measurement of plasma IgA levels to assess humoral immune response.
Change in Immunoglobulin G (IgG) level
Time frame: Baseline and 12 weeks
Measurement of plasma IgG levels to assess humoral immune response.
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.
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.
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.
5 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline and 12 weeks
Change in Patient-Generated Subjective Global Assessment (PG-SGA) score
Time frame: Baseline and 12 weeks
Change in Quality of Life (WHOQOL-100) score
Time frame: Baseline and 12 weeks
3-Year Overall Survival Rate
Time frame: Up to 3 years
Incidence of Major Treatment-Related Complications
Time frame: During the 12-week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Dietary Fiber and Probiotics. and Standard Nutritional Support in people with Colorectal Cancer (MSI-H) and Malnutrition (Calorie), run by The First Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Immunoglobulin A (IgA) level (time frame: Baseline and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.