Colorectal CancerNCT07863154
Probiotic Supplementation During Neoadjuvant Chemoradiotherapy in Colorectal Cancer
A study testing Multistrain Probiotic Formulation in people with Colorectal Cancer, run by University of Malaga at 1 site in Spain.
Trial summary
This prospective randomized, double-blind, placebo-controlled study evaluated the effects of multistrain probiotic supplementation in patients with stage II-III colorectal cancer undergoing neoadjuvant chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Multistrain Probiotic Formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2015to 10 Jul 2019
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 35 and 75 years of age.
- Histologically diagnosed stage II-III colorectal cancer.
- Tumor stage T2-T4 and/or N1-N2.
- Scheduled to receive neoadjuvant chemoradiotherapy consisting of pelvic radiotherapy and oral capecitabine.
Who cannot join
- Previous colorectal cancer.
- Previous bowel resection.
- Type 2 diabetes mellitus.
- Chronic inflammatory bowel disease.
- Severe infections.
- Hereditary colorectal cancer syndromes.
Show all 14Show fewer
- Metastatic disease.
- Pregnancy.
- Previous pelvic radiotherapy or anti-tumor treatment during the preceding two years.
- Antibiotic or immunosuppressive treatment during the preceding two months.
- Regular use of NSAIDs.
- Regular use of statins.
- Regular consumption of probiotics or prebiotics.
- Excessive dietary fiber consumption.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Multistrain Probiotic Supplementation During Neoadjuvant Chemoradiotherapy in Patients With Colorectal Cancer: A Randomized Placebo-Controlled Study
This prospective randomized, double-blind, placebo-controlled study evaluated the effects of multistrain probiotic supplementation in patients with stage II-III colorectal cancer undergoing neoadjuvant chemoradiotherapy. Participants received either a multistrain probiotic or placebo twice daily for five weeks during chemoradiotherapy. The study evaluated changes in gut microbiota composition and diversity, as well as fecal short-chain fatty acids, inflammatory cytokines, zonulin, gastrointestinal symptoms, and quality of life. Participants were assessed at baseline, during treatment, at the end of treatment, and seven weeks after completion of treatment.
Read the detailed description
Neoadjuvant chemoradiotherapy is commonly used in patients with locally advanced colorectal cancer, but treatment may be associated with gastrointestinal toxicity, intestinal dysbiosis, disruption of epithelial barrier function, systemic inflammation, and deterioration of health-related quality of life. Modulation of the intestinal microbiota using probiotics has been proposed as a potential supportive strategy to mitigate these treatment-related alterations.
This study was designed to evaluate the effects of a multistrain probiotic formulation administered during neoadjuvant chemoradiotherapy in patients with stage II-III colorectal cancer. The study focused on the potential effects of probiotic supplementation on treatment-related alterations in the intestinal microbiota and other biological and patient-reported parameters.
The primary objective was to evaluate the effect of multistrain probiotic supplementation on gut microbiota composition and diversity in patients with stage II-III colorectal cancer undergoing neoadjuvant chemoradiotherapy. Secondary objectives included evaluating the effects of probiotic supplementation on fecal short-chain fatty acid concentrations, systemic inflammatory cytokines, intestinal permeability, and gastrointestinal symptoms and health-related quality of life.
- Conditions
- Colorectal Cancer
- Being tested
- Multistrain Probiotic Formulation, Placebo
- Keywords
- Gut Microbiota, Probiotics, Neoadjuvant Chemoradiotherapy, Short-Chain Fatty Acids, Intestinal Permeability, Quality of Life
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multistrain Probiotic FormulationDietary supplement
Multistrain probiotic formulation containing Saccharomyces boulardii 600 mg, Lactobacillus rhamnosus GG 6 × 10^9 CFU, Lactobacillus helveticus 4 × 10^9 CFU, Bifidobacterium longum 4 × 10^9 CFU, fructooligosaccharides 500 mg, and vitamin D3 2.5 μg (100 IU). The probiotic was administered orally twice daily for five weeks during neoadjuvant chemoradiotherapy.
PlaceboDietary supplement
Placebo containing fructooligosaccharides 500 mg and vitamin D3 2.5 μg (100 IU), without probiotic strains or yeast. The placebo was administered orally twice daily for five weeks during neoadjuvant chemoradiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Multistrain Probiotic | Experimental | Participants received a multistrain probiotic formulation orally twice daily for five weeks during neoadjuvant chemoradiotherapy. Receives: Dietary Supplement: Multistrain Probiotic Formulation |
| Placebo | Placebo comparator | Participants received a placebo orally twice daily for five weeks during neoadjuvant chemoradiotherapy. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota composition and diversity
Gut microbiota composition and diversity assessed in fecal samples using 16S rRNA gene sequencing, including alpha diversity, beta diversity, and taxonomic composition.
Measured: At baseline (T0), week 2 (T1), week 5/end of treatment (T2), and seven weeks after completion of treatment (T3).
Secondary outcomes (4)
Fecal short-chain fatty acid concentrations
Fecal concentrations of acetic, propionic, isobutyric, butyric, isovaleric, and valeric acids were determined by gas chromatography coupled to triple quadrupole mass spectrometry (GC-MS/MS).
Measured: Baseline (T0) and 7 weeks after treatment completion (T3).
Serum inflammatory cytokine concentrations
Circulating concentrations of IL-6, IFN-α, IL-10, and IL-1β were quantified using enzyme-linked immunosorbent assays (ELISA) and compared between the probiotic and placebo groups.
Measured: Baseline (T0) and 7 weeks after treatment completion (T3).
Circulating zonulin concentration as a marker of intestinal permeability
Zonulin concentrations were measured by ELISA as a marker of intestinal permeability and compared between the probiotic and placebo groups.
Measured: Baseline (T0) and 7 weeks after treatment completion (T3).
Health-related quality of life and gastrointestinal symptoms assessed using the EORTC QLQ-C30
Health-related quality of life and symptom burden were evaluated using the EORTC QLQ-C30 version 3.0. The questionnaire assesses global health status/quality of life, functional domains, symptom scales, and individual symptoms including diarrhea, constipation, appetite loss, nausea and vomiting, fatigue, pain, dyspnea, insomnia/sleep disturbance, and other cancer-related symptoms. Scores were transformed to a 0-100 scale according to the EORTC scoring manual. Higher functional and global health scores indicate better functioning/quality of life, whereas higher symptom scores indicate greater symptom burden.
Measured: 7 weeks after treatment completion (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Nov 2015
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Isabel Queipo Ortuño, University of Malaga
- Investigators
- María Isabel Queipo Ortuño, PhD, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863154
- Sponsor's protocol ID
- PI15/000256
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chitapanarux I, Chitapanarux T, Traisathit P, Kudumpee S, Tharavichitkul E, Lorvidhaya V. Randomized controlled trial of live lactobacillus acidophilus plus bifidobacterium bifidum in prophylaxis of diarrhea during radiotherapy in cervical cancer patients. Radiat Oncol. 2010 May 5;5:31. doi: 10.1186/1748-717X-5-31.
PubMed 20444243
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multistrain Probiotic Supplementation During Neoadjuvant Chemoradiotherapy in Patients With Colorectal Cancer: A Randomized Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07863154
- Acronym / sponsor ID
- PI15/000256
- Conditions
- Colorectal Cancer
- Keywords
- Gut Microbiota, Probiotics, Neoadjuvant Chemoradiotherapy, Short-Chain Fatty Acids, Intestinal Permeability, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 7 Oct 2026 (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 prospective randomized, double-blind, placebo-controlled study evaluated the effects of multistrain probiotic supplementation in patients with stage II-III colorectal cancer undergoing neoadjuvant chemoradiotherapy. Participants received either a multistrain probiotic or placebo twice daily for five weeks during chemoradiotherapy. The study evaluated changes in gut microbiota composition and diversity, as well as fecal short-chain fatty acids, inflammatory cytokines, zonulin, gastrointestinal symptoms, and quality of life. Participants were assessed at baseline, during treatment, at the end of treatment, and seven weeks after completion of treatment.
Detailed description
Neoadjuvant chemoradiotherapy is commonly used in patients with locally advanced colorectal cancer, but treatment may be associated with gastrointestinal toxicity, intestinal dysbiosis, disruption of epithelial barrier function, systemic inflammation, and deterioration of health-related quality of life. Modulation of the intestinal microbiota using probiotics has been proposed as a potential supportive strategy to mitigate these treatment-related alterations.
This study was designed to evaluate the effects of a multistrain probiotic formulation administered during neoadjuvant chemoradiotherapy in patients with stage II-III colorectal cancer. The study focused on the potential effects of probiotic supplementation on treatment-related alterations in the intestinal microbiota and other biological and patient-reported parameters.
The primary objective was to evaluate the effect of multistrain probiotic supplementation on gut microbiota composition and diversity in patients with stage II-III colorectal cancer undergoing neoadjuvant chemoradiotherapy. Secondary objectives included evaluating the effects of probiotic supplementation on fecal short-chain fatty acid concentrations, systemic inflammatory cytokines, intestinal permeability, and gastrointestinal symptoms and health-related quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multistrain Probiotic | Experimental | Dietary Supplement: Multistrain Probiotic FormulationParticipants received a multistrain probiotic formulation orally twice daily for five weeks during neoadjuvant chemoradiotherapy. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants received a placebo orally twice daily for five weeks during neoadjuvant chemoradiotherapy. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females between 35 and 75 years of age.
- Histologically diagnosed stage II-III colorectal cancer.
- Tumor stage T2-T4 and/or N1-N2.
- Scheduled to receive neoadjuvant chemoradiotherapy consisting of pelvic radiotherapy and oral capecitabine.
Key exclusion criteria (14 listed)
- Previous colorectal cancer.
- Previous bowel resection.
- Type 2 diabetes mellitus.
- Chronic inflammatory bowel disease.
- Severe infections.
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 |
|---|---|---|
| Multistrain Probiotic FormulationMultistrain probiotic formulation containing Saccharomyces boulardii 600 mg, Lactobacillus rhamnosus GG 6 × 10^9 CFU, Lactobacillus helveticus 4 × 10^9 CFU, Bifidobacterium longum 4 × 10^9 CFU, fructooligosaccharides 500 mg, and vitamin D3 2.5 μg (100 IU). The probiotic was administered orally twice daily for five weeks during neoadjuvant chemoradiotherapy. | Dietary supplement | Multistrain Probiotic |
| PlaceboPlacebo containing fructooligosaccharides 500 mg and vitamin D3 2.5 μg (100 IU), without probiotic strains or yeast. The placebo was administered orally twice daily for five weeks during neoadjuvant chemoradiotherapy. | Dietary supplement | Placebo |
Primary outcome
Gut microbiota composition and diversity
Time frame: At baseline (T0), week 2 (T1), week 5/end of treatment (T2), and seven weeks after completion of treatment (T3).
Gut microbiota composition and diversity assessed in fecal samples using 16S rRNA gene sequencing, including alpha diversity, beta diversity, and taxonomic composition.
4 secondary outcomes
Fecal short-chain fatty acid concentrations
Time frame: Baseline (T0) and 7 weeks after treatment completion (T3).
Serum inflammatory cytokine concentrations
Time frame: Baseline (T0) and 7 weeks after treatment completion (T3).
Circulating zonulin concentration as a marker of intestinal permeability
Time frame: Baseline (T0) and 7 weeks after treatment completion (T3).
Health-related quality of life and gastrointestinal symptoms assessed using the EORTC QLQ-C30
Time frame: 7 weeks after treatment completion (T3).
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 7 Oct 2026.
- Background: PubMed 20444243Chitapanarux I, Chitapanarux T, Traisathit P, Kudumpee S, Tharavichitkul E, Lorvidhaya V. Randomized controlled trial of live lactobacillus acidophilus plus bifidobacterium bifidum in prophylaxis of diarrhea during radiotherapy in cervical cancer patients. Radiat Oncol. 2010 May 5;5:31. doi: 10.1186/1748-717X-5-31.
- Individual participant dataSharing planned: No
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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.
María Isabel Queipo Ortuño, PhD principal investigator
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multistrain Probiotic Formulation in people with Colorectal Cancer, run by University of Malaga at 1 site in Spain.
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 4 inclusion and 14 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 7 Oct 2026. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Gut microbiota composition and diversity (time frame: At baseline (T0), week 2 (T1), week 5/end of treatment (T2), and seven weeks after completion of treatment (T3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07863154, which also lists 1 linked publication.
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 7 Oct 2026.