Colo-rectal CancerNCT06576986
Effect of Synbiotic Supplementation on the Prevention of Mucositis in Cancer Patients Undergoing Chemotherapy
A study testing Symbiotic and Maltodextrin in people with Colo-rectal Cancer, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Introduction: In the 2023-2025 period, colorectal cancer (CRC) will be the third most common type of cancer in Brazil. The most commonly used therapeutic approaches are chemotherapy (QTx) and radiotherapy (RTx). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Symbiotic and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Dec 2023to 12 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colorectal tumor in the first oncological treatment
- Age over 18 years old
- Both sexes
- Eligible for protocol with capecitabine alone or associated with oxaliplatin
- Patients WITHOUT colostomy or WITH colostomy in the transverse/descending/sigmoid region
- Patient undergoing Radiotherapy treatment associated with Chemotherapy
- Patients residing in Belo Horizonte and the metropolitan region
- Patients who Accept and sign the Informed Consent Form (TCLE)
Who cannot join
- Diagnosis of gastrointestinal carcinoid and stromal tumor (GIST)
- Patients with Ileostomy
- Patients with colostomy in the ascending region of the colon
- Inflammatory bowel diseases: Crohn's and Colitis
- Use of antibiotics and antifungals in the last 15 days
- Use of prebiotic/probiotic and/or synbiotic in the last 15 days
Show all 10Show fewer
- Use of antidiarrheal medication in the last 15 days
- Presence of fever and mucus discharge
- Pregnant or breastfeeding women
- Patients who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Escola de Enfermagem - UFMG
Belo Horizonte, Minas Gerais, 30130-100
Simone V Generoso, 988128650 ext. +55(31), simonenutufmg@gmail.com
About this study
Official title: Effect of Synbiotic Supplementation on the Prevention of Mucositis in Cancer Patients Undergoing Chemotherapy: Randomized, Double-masked, Parallel, Single-center Clinical Trial
Introduction: In the 2023-2025 period, colorectal cancer (CRC) will be the third most common type of cancer in Brazil. The most commonly used therapeutic approaches are chemotherapy (QTx) and radiotherapy (RTx). QTx agents, such as capecitabine, affect both malignant cells and normal cells such as gastrointestinal, capillary and immune cells. Cellular damage in the gastrointestinal tract (GIT) results in various symptoms, such as mucositis and diarrhea. Diarrhea is linked to mucosal damage and can result in dehydration, malnutrition and hospitalization, leading to cardiovascular complications and death. Mucositis is inflammation that affects the GIT. This condition makes treatment difficult, leading to reductions, delays or interruption of QTx. These scenarios harm the patient's prognosis and quality of life, resulting in high costs for symptom control, nutritional assistance, management of secondary infections and hospitalization. The Mucositis Study Group (MASCC/ISOO) guidelines recommend the use of probiotics as a preventive measure against diarrhea in cancer patients undergoing QTx and/or RTx. However, the safety of using probiotics in immunosuppressed patients is still controversial and hypotheses are based on epidemiological and experimental studies. This makes it necessary to evaluate whether supplementation with pro- or synbiotics before chemotherapy would have the same beneficial results. Objective: To evaluate the effect of synbiotic supplementation on the prevention, incidence and severity of mucositis in cancer patients undergoing QTx. Method: This is a single-center parallel double-masked randomized clinical trial to be carried out at the Borges da Costa/UFMG Outpatient Clinic at Hospital das Clínicas in Belo Horizonte - Minas Gerais (HC-BH/MG). The inclusion criteria are patients diagnosed with CRC eligible for first-line treatment with Capecitabine, aged ≥ 18 years, both sexes, signed the informed consent form. The study was approved by CEP-UFMG. Expected results: It is expected that supplementation with synbiotics in the pre-QTx period will promote modulation of the microbiota and strengthening of the intestinal barrier, resulting in a lower incidence and severity of mucositis and diarrhea, improving the quality of life of these patients.
Read the detailed description
Introduction: In the triennium 2023-2025, colorectal cancer (CRC) will be the third most common type of cancer in Brazil. The most used therapeutic approaches are chemotherapy (QTx) and radiotherapy (RTx). Chemotherapeutic agents, such as capecitabine, affect both malignant cells and normal cells such as gastrointestinal, capillary, and immune cells. Cellular damage in the gastrointestinal tract (GIT) results in various symptoms, such as mucositis and diarrhea. Diarrhea is linked to mucosal injury and can lead to dehydration, malnutrition, hospitalization, cardiovascular complications, and death. Mucositis, on the other hand, is inflammation that affects the GIT. This condition hinders treatment, leading to reductions, delays, or interruption of QTx. These scenarios impair the prognosis and quality of life of the patient, resulting in high costs for symptom control, nutritional support, management of secondary infections, and hospitalization. The Mucositis Study Group guidelines (MASCC/ISOO) recommend the use of probiotics as a preventive measure against diarrhea in cancer patients undergoing QTx and/or RTx. However, the safety of probiotic use in immunosuppressed patients is still controversial, and hypotheses are based on epidemiological and experimental studies. Therefore, it is necessary to evaluate whether supplementation with probiotics or symbiotics before chemotherapy would have the same beneficial results. Objective: The general objective of this study is to evaluate if symbiotic supplementation can reduce the incidence and severity of oral mucositis in cancer patients undergoing chemotherapy. Specific objectives include assessing the tolerability of supplementation, analyzing clinical and laboratory parameters related to mucositis, and investigating the impact of the intervention on the quality of life of patients. Methodology: This is a randomized, double-blind, parallel, single-center clinical trial to be conducted at the Borges da Costa Outpatient Clinic located at the Hospital das Clínicas of the Federal University of Minas Gerais in Belo Horizonte (HC-UFMG). Inclusion criteria involve adult patients, aged ≥ 18 years, of both sexes, diagnosed with colorectal cancer and candidates for first-line chemotherapy treatment with Capecitabine alone or in combination with Oxaliplatin, treated at HC/UFMG under the signature of the Informed Consent Form (ICF) and able to follow the research guidelines. The study was approved by the Research Ethics Committee of UFMG (CEP-UFMG) under protocol number CAAE 30177920.2.0000.5149. The study involves 80 participants distributed according to the chemotherapy protocol. Patients will be randomly divided into two groups designated as A and B: one control group receiving Maltodextrin, and the other intervention group receiving Symbiotic. The supplementation will be administered for 10 days, twice a day, before the start of chemotherapy treatment. Biological samples, such as feces and blood, will be collected for analysis of intestinal microbiota, short-chain fatty acid (SCFA) levels, presence of infection, intestinal permeability, and inflammatory markers. Biological collections will be performed at different time points throughout the study, including before supplementation (D0-D1), on the 10th day of supplementation (D10 pre-QTx), and on days 14 and 21 of the first chemotherapy cycle (D14-QTx and D21-QTx). Data will be collected through nutritional, anthropometric, and dietary assessments, including the Subjective Global Assessment (SGA), Anthropometric Assessment, Dietary Assessment (24h Recall and Food Frequency Questionnaire), as well as assessment of intestinal function and digestive complaints. Patients will be monitored daily, along with follow-up during treatment and data recording in the electronic medical record. Statistical analysis of the data will include sample size calculation, appropriate statistical tests, and an exploratory approach to evaluate clinical outcomes and study results. Expected Results It is expected that the results of this study will provide evidence on the efficacy of symbiotic supplementation in preventing oral mucositis in CRC patients undergoing chemotherapy. If the intervention proves to be effective, it could contribute to the development of more effective nutritional strategies in managing the side effects of oncological treatment, improving the quality of life and well-being of patients.
- Conditions
- Colo-rectal Cancer
- Being tested
- Symbiotic, Maltodextrin
- Keywords
- colorectal cancer, symbiotic, Mucositis, diarrhea, chemotherapy
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, Mucositis, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymbioticDietary supplement
Also called Simbioflora
The synbiotic used will be Simbioflora® (commercial preparation containing 5.5g of FOS added with four species of probiotic, Lactobacillus paracasei LPC-31; Lactobacillus rhamnosus HN001; Lactobacillus acidophilus NCFM; Bifidobacterium lactis HN019, at a concentration of 109 UFC per strain) supplied by Farmoquímica S.A. Supplementation will be administered orally, twice a day, before lunch and dinner, for ten days before chemotherapy treatment. Patients will be guided by researchers on dilution (100 mL of filtered water) and the correct purchase of the modules. Consumption control will be carried out daily, via telephone contact.
MaltodextrinDietary supplement
Maltodextrin, used as control, will be purchased from the company PRODIET® under the trade name Carboch®. Supplementation will be administered orally, twice a day, before lunch and dinner, for ten days before chemotherapy treatment. Patients will be guided by researchers on dilution (100 mL of filtered water) and the correct purchase of the modules. Consumption control will be carried out daily, via telephone contact.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine alone control | Placebo comparator | n the Control Group, patients received Maltodextrin as supplementation Receives: Dietary Supplement: Maltodextrin |
| Capecitabine alone synbiotic | Experimental | In the Intervention Group, patients received the symbiotic Simbioflora as supplementation. Receives: Dietary Supplement: Symbiotic |
| Capecitabine associated with control Oxaliplatin | Placebo comparator | n the Control Group, patients received Maltodextrin as supplementation Receives: Dietary Supplement: Maltodextrin |
| Capecitabine associated with synbiotic Oxaliplatin | Experimental | In the Intervention Group, patients received the symbiotic Simbioflora as supplementation. Receives: Dietary Supplement: Symbiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal Microbiota
Fecal calprotectin measured by ELISA.
Measured: six months after collecting data from all research participants
Intestinal Microbiota
production of short-chain fatty acids.
Measured: six months after collecting data from all research participants
Intestinal Microbiota
analysis of intestinal microbiota composition by sequencing the 16S rRNA gene.
Measured: six months after collecting data from all research participants
Clinical Nutritional Diagnostic
Body mass index BMI in kg/m²
Measured: six months after collecting data from all research participants
Nutritional Diagnostic
body weight in kg
Measured: six months after collecting data from all research participants
Nutritional Diagnostic
height in m
Measured: six months after collecting data from all research participants
Nutritional Diagnostic
circumferences in cm
Measured: six months after collecting data from all research participants
Nutritional Diagnostic
body composition via triceps skin fold thickness in mm
Measured: six months after collecting data from all research participants
Nutritional Diagnostic
hand grip resistance assessed by dynamometry in kg
Measured: six months after collecting data from all research participants
Nutritional Diagnostic
Food Frequency Questionnaire
Measured: six months after collecting data from all research participants
Nutritional Diagnostic
24-hour recall
Measured: six months after collecting data from all research participants
Effect of the synbiotic in pain
Visual Analogue Score for Pain using the Visual Analogue Scale
Measured: six months after collecting data from all research participants
inflammatory marker
Blood samples for Tumor Necrosis Factor TNF in pg/mL
Measured: six months after collecting data from all research participants
inflammatory marker
Fatty Acid Binding Protein FABP2 in ng/mL
Measured: six months after collecting data from all research participants
inflammatory marker
Lipopolysaccharide Binding Protein LBP in µg/mL
Measured: six months after collecting data from all research participants
inflammatory marker
Lipopolysaccharide LPS in µg/mL
Measured: six months after collecting data from all research participants
inflammatory marker
leukogram White Blood Cell Count in cells/µL
Measured: six months after collecting data from all research participants
Questionnaire to assess quality of life
EORTC QLQ-C30 for all cancer patients
Measured: six months after collecting data from all research participants
Questionnaire to assess quality of life
EORTC QLQ-CR29 for colorectal cancer patients
Measured: six months after collecting data from all research participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start12 Dec 2023
- Primary completion12 Dec 2025 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
- Investigators
- Simone de Vasconcelos Generoso, Principal investigator, Escola de Enfermagem - UFMG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576986
- Sponsor's protocol ID
- 30177920200005149
- Status last verified
- Aug 2024
- First submitted
- 11 May 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Synbiotic Supplementation on the Prevention of Mucositis in Cancer Patients Undergoing Chemotherapy: Randomized, Double-masked, Parallel, Single-center Clinical Trial
- ClinicalTrials.gov ID
- NCT06576986
- Acronym / sponsor ID
- 30177920200005149
- Conditions
- Colo-rectal Cancer
- Keywords
- colorectal cancer, symbiotic, Mucositis, diarrhea, chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 29 Aug 2024 (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.
Introduction: In the 2023-2025 period, colorectal cancer (CRC) will be the third most common type of cancer in Brazil. The most commonly used therapeutic approaches are chemotherapy (QTx) and radiotherapy (RTx). QTx agents, such as capecitabine, affect both malignant cells and normal cells such as gastrointestinal, capillary and immune cells. Cellular damage in the gastrointestinal tract (GIT) results in various symptoms, such as mucositis and diarrhea. Diarrhea is linked to mucosal damage and can result in dehydration, malnutrition and hospitalization, leading to cardiovascular complications and death. Mucositis is inflammation that affects the GIT. This condition makes treatment difficult, leading to reductions, delays or interruption of QTx. These scenarios harm the patient's prognosis and quality of life, resulting in high costs for symptom control, nutritional assistance, management of secondary infections and hospitalization. The Mucositis Study Group (MASCC/ISOO) guidelines recommend the use of probiotics as a preventive measure against diarrhea in cancer patients undergoing QTx and/or RTx. However, the safety of using probiotics in immunosuppressed patients is still controversial and hypotheses are based on epidemiological and experimental studies. This makes it necessary to evaluate whether supplementation with pro- or synbiotics before chemotherapy would have the same beneficial results. Objective: To evaluate the effect of synbiotic supplementation on the prevention, incidence and severity of mucositis in cancer patients undergoing QTx. Method: This is a single-center parallel double-masked randomized clinical trial to be carried out at the Borges da Costa/UFMG Outpatient Clinic at Hospital das Clínicas in Belo Horizonte - Minas Gerais (HC-BH/MG). The inclusion criteria are patients diagnosed with CRC eligible for first-line treatment with Capecitabine, aged ≥ 18 years, both sexes, signed the informed consent form. The study was approved by CEP-UFMG. Expected results: It is expected that supplementation with synbiotics in the pre-QTx period will promote modulation of the microbiota and strengthening of the intestinal barrier, resulting in a lower incidence and severity of mucositis and diarrhea, improving the quality of life of these patients.
Detailed description
Introduction: In the triennium 2023-2025, colorectal cancer (CRC) will be the third most common type of cancer in Brazil. The most used therapeutic approaches are chemotherapy (QTx) and radiotherapy (RTx). Chemotherapeutic agents, such as capecitabine, affect both malignant cells and normal cells such as gastrointestinal, capillary, and immune cells. Cellular damage in the gastrointestinal tract (GIT) results in various symptoms, such as mucositis and diarrhea. Diarrhea is linked to mucosal injury and can lead to dehydration, malnutrition, hospitalization, cardiovascular complications, and death. Mucositis, on the other hand, is inflammation that affects the GIT. This condition hinders treatment, leading to reductions, delays, or interruption of QTx. These scenarios impair the prognosis and quality of life of the patient, resulting in high costs for symptom control, nutritional support, management of secondary infections, and hospitalization. The Mucositis Study Group guidelines (MASCC/ISOO) recommend the use of probiotics as a preventive measure against diarrhea in cancer patients undergoing QTx and/or RTx. However, the safety of probiotic use in immunosuppressed patients is still controversial, and hypotheses are based on epidemiological and experimental studies. Therefore, it is necessary to evaluate whether supplementation with probiotics or symbiotics before chemotherapy would have the same beneficial results. Objective: The general objective of this study is to evaluate if symbiotic supplementation can reduce the incidence and severity of oral mucositis in cancer patients undergoing chemotherapy. Specific objectives include assessing the tolerability of supplementation, analyzing clinical and laboratory parameters related to mucositis, and investigating the impact of the intervention on the quality of life of patients. Methodology: This is a randomized, double-blind, parallel, single-center clinical trial to be conducted at the Borges da Costa Outpatient Clinic located at the Hospital das Clínicas of the Federal University of Minas Gerais in Belo Horizonte (HC-UFMG). Inclusion criteria involve adult patients, aged ≥ 18 years, of both sexes, diagnosed with colorectal cancer and candidates for first-line chemotherapy treatment with Capecitabine alone or in combination with Oxaliplatin, treated at HC/UFMG under the signature of the Informed Consent Form (ICF) and able to follow the research guidelines. The study was approved by the Research Ethics Committee of UFMG (CEP-UFMG) under protocol number CAAE 30177920.2.0000.5149. The study involves 80 participants distributed according to the chemotherapy protocol. Patients will be randomly divided into two groups designated as A and B: one control group receiving Maltodextrin, and the other intervention group receiving Symbiotic. The supplementation will be administered for 10 days, twice a day, before the start of chemotherapy treatment. Biological samples, such as feces and blood, will be collected for analysis of intestinal microbiota, short-chain fatty acid (SCFA) levels, presence of infection, intestinal permeability, and inflammatory markers. Biological collections will be performed at different time points throughout the study, including before supplementation (D0-D1), on the 10th day of supplementation (D10 pre-QTx), and on days 14 and 21 of the first chemotherapy cycle (D14-QTx and D21-QTx). Data will be collected through nutritional, anthropometric, and dietary assessments, including the Subjective Global Assessment (SGA), Anthropometric Assessment, Dietary Assessment (24h Recall and Food Frequency Questionnaire), as well as assessment of intestinal function and digestive complaints. Patients will be monitored daily, along with follow-up during treatment and data recording in the electronic medical record. Statistical analysis of the data will include sample size calculation, appropriate statistical tests, and an exploratory approach to evaluate clinical outcomes and study results. Expected Results It is expected that the results of this study will provide evidence on the efficacy of symbiotic supplementation in preventing oral mucositis in CRC patients undergoing chemotherapy. If the intervention proves to be effective, it could contribute to the development of more effective nutritional strategies in managing the side effects of oncological treatment, improving the quality of life and well-being of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Capecitabine alone control | Placebo comparator | Dietary Supplement: Maltodextrinn the Control Group, patients received Maltodextrin as supplementation |
| Capecitabine alone synbiotic | Experimental | Dietary Supplement: SymbioticIn the Intervention Group, patients received the symbiotic Simbioflora as supplementation. |
| Capecitabine associated with control Oxaliplatin | Placebo comparator | Dietary Supplement: Maltodextrinn the Control Group, patients received Maltodextrin as supplementation |
| Capecitabine associated with synbiotic Oxaliplatin | Experimental | Dietary Supplement: SymbioticIn the Intervention Group, patients received the symbiotic Simbioflora as supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Colorectal tumor in the first oncological treatment
- Age over 18 years old
- Both sexes
- Eligible for protocol with capecitabine alone or associated with oxaliplatin
- Patients WITHOUT colostomy or WITH colostomy in the transverse/descending/sigmoid region
Key exclusion criteria (10 listed)
- Diagnosis of gastrointestinal carcinoid and stromal tumor (GIST)
- Patients with Ileostomy
- Patients with colostomy in the ascending region of the colon
- Inflammatory bowel diseases: Crohn's and Colitis
- Use of antibiotics and antifungals in the last 15 days
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 |
|---|---|---|
| SymbioticAlso: SimbiofloraThe synbiotic used will be Simbioflora® (commercial preparation containing 5.5g of FOS added with four species of probiotic, Lactobacillus paracasei LPC-31; Lactobacillus rhamnosus HN001; Lactobacillus acidophilus NCFM; Bifidobacterium lactis HN019, at a concentration of 109 UFC per strain) supplied by Farmoquímica S.A. Supplementation will be administered orally, twice a day, before lunch and dinner, for ten days before chemotherapy treatment. Patients will be guided by researchers on dilution (100 mL of filtered water) and the correct purchase of the modules. Consumption control will be carried out daily, via telephone contact. | Dietary supplement | Capecitabine alone synbiotic, Capecitabine associated with synbiotic Oxaliplatin |
| MaltodextrinMaltodextrin, used as control, will be purchased from the company PRODIET® under the trade name Carboch®. Supplementation will be administered orally, twice a day, before lunch and dinner, for ten days before chemotherapy treatment. Patients will be guided by researchers on dilution (100 mL of filtered water) and the correct purchase of the modules. Consumption control will be carried out daily, via telephone contact. | Dietary supplement | Capecitabine alone control, Capecitabine associated with control Oxaliplatin |
Primary outcome
Intestinal Microbiota
Time frame: six months after collecting data from all research participants
Fecal calprotectin measured by ELISA.
Intestinal Microbiota
Time frame: six months after collecting data from all research participants
production of short-chain fatty acids.
Intestinal Microbiota
Time frame: six months after collecting data from all research participants
analysis of intestinal microbiota composition by sequencing the 16S rRNA gene.
Clinical Nutritional Diagnostic
Time frame: six months after collecting data from all research participants
Body mass index BMI in kg/m²
Nutritional Diagnostic
Time frame: six months after collecting data from all research participants
body weight in kg
Nutritional Diagnostic
Time frame: six months after collecting data from all research participants
height in m
Nutritional Diagnostic
Time frame: six months after collecting data from all research participants
circumferences in cm
Nutritional Diagnostic
Time frame: six months after collecting data from all research participants
body composition via triceps skin fold thickness in mm
Nutritional Diagnostic
Time frame: six months after collecting data from all research participants
hand grip resistance assessed by dynamometry in kg
Nutritional Diagnostic
Time frame: six months after collecting data from all research participants
Food Frequency Questionnaire
Nutritional Diagnostic
Time frame: six months after collecting data from all research participants
24-hour recall
Effect of the synbiotic in pain
Time frame: six months after collecting data from all research participants
Visual Analogue Score for Pain using the Visual Analogue Scale
inflammatory marker
Time frame: six months after collecting data from all research participants
Blood samples for Tumor Necrosis Factor TNF in pg/mL
inflammatory marker
Time frame: six months after collecting data from all research participants
Fatty Acid Binding Protein FABP2 in ng/mL
inflammatory marker
Time frame: six months after collecting data from all research participants
Lipopolysaccharide Binding Protein LBP in µg/mL
inflammatory marker
Time frame: six months after collecting data from all research participants
Lipopolysaccharide LPS in µg/mL
inflammatory marker
Time frame: six months after collecting data from all research participants
leukogram White Blood Cell Count in cells/µL
Questionnaire to assess quality of life
Time frame: six months after collecting data from all research participants
EORTC QLQ-C30 for all cancer patients
Questionnaire to assess quality of life
Time frame: six months after collecting data from all research participants
EORTC QLQ-CR29 for colorectal cancer patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
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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.
Simone de Vasconcelos Generoso principal investigator
Escola de Enfermagem - UFMG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symbiotic and Maltodextrin in people with Colo-rectal Cancer, run by Federal University of Minas Gerais at 1 site in Brazil.
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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 29 Aug 2024. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone de Vasconcelos Generoso (988128650 ext. +55(031), simonenutufmg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal Microbiota (time frame: six months after collecting data from all research participants). The study lists 19 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 29 Aug 2024.