ChemobrainNCT07465497
Impact of Supplementation With Synbiotics and Prebiotics on Cognitive Decline Associated With Neoadjuvant Chemotherapy in First-line Patients With Breast Cancer
A study testing Synbiotics Blend, Synbiotics + Vitamin D and Prebiotic in people with Chemobrain and Breast Cancer, run by Instituto Jalisciense de Cancerologia at 1 site in Mexico.
Trial summary
The goal of this research protocol is to evaluate whether supplementation with: synbiotics (probiotics with agave inulin), synbiotics with vitamid D or prebiotics (agave inulin) can reduce cognitive decline in patients with breast cancer undergoing neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemobrain, Breast Cancer, Inflammatory Disease
- What is being tested?
- Synbiotics Blend, Synbiotics + Vitamin D and Prebiotic
- 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 siteMexico
- Study dates
- 27 Feb 2026to Feb 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Participants must be between 18 and 75 years old.
- Diagnosis: Must have a confirmed diagnosis of breast cancer at stages IB to IIIC.
- Treatment Status: Participants should be scheduled to receive neoadjuvant chemotherapy as part of their treatment plan.
- Cognitive Function: Must demonstrate baseline cognitive function as assessed by the CERAD neuropsychological battery, indicating no severe cognitive impairment.
- Informed Consent: Participants must provide written informed consent to participate in the study and comply with all study procedures.
- Health Status: Should not have any significant comorbidities that could interfere with the study outcomes, such as severe psychiatric disorders or neurological conditions.
- No Previous Probiotic Use: Must not have used probiotics or prebiotics in the month prior to the study
Who cannot join
- Severe Cognitive Impairment: Participants with significant cognitive impairment or dementia as assessed by the CERAD neuropsychological battery will be excluded.
- Severe Comorbidities: Participants with serious comorbid conditions, such as uncontrolled diabetes, severe cardiovascular diseases, or active infections, will be excluded.
- Psychiatric Disorders: Individuals with a history of severe psychiatric disorders that could affect cognitive function or compliance with the study protocol will be excluded.
- Neurological Conditions: Participants with neurological disorders such as multiple sclerosis, Parkinson's disease, or other conditions that affect cognitive function will be excluded.
- Pregnant or Lactating Women: Pregnant or breastfeeding women will not be eligible to participate in the study.
- Allergies: Individuals with known allergies to any of the components of the synbiotics or prebiotics used in the study will be excluded.
- Non-compliance Risk: Participants who are deemed at risk of non-compliance with study procedures or follow-up will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Supplementation With Synbiotics and Prebiotics on Cognitive Decline Associated With Neoadjuvant Chemotherapy in First-line Patients With Breast Cancer at Stages IB to IIIC of Any Molecular Subtype.
The goal of this research protocol is to evaluate whether supplementation with: synbiotics (probiotics with agave inulin), synbiotics with vitamid D or prebiotics (agave inulin) can reduce cognitive decline in patients with breast cancer undergoing neoadjuvant chemotherapy. It will also assess the safety of these supplements. The main questions it aims to answer are:
Does supplementation with synbiotics and prebiotics decrease cognitive decline in participants? What adverse effects do participants experience while taking these supplements? Are there significant changes in inflammation markers (calprotectin and C-reactive protein) before and after treatment?
Read more
Participants will:
Receive either synbiotics, prebiotics or none daily for 4 months. Undergo cognitive assessments using the CERAD neuropsychological battery at the beginning and end of the study.
Provide blood and stool samples for analysis of inflammation markers. Report any adverse effects experienced during the supplementation period.
Read the detailed description
The primary aim of this research is to investigate the effects of supplementation with synbiotics and prebiotics on cognitive decline in patients diagnosed with breast cancer who are undergoing neoadjuvant chemotherapy.
This study will utilize a double-blind, randomized design. Group 1: synbiotics (Lactobacillus acidophilus (LA3) Lactobacillus delbrueckii subsp. bulgaricus (SP 96) Lactobacillus casei (BGP 93) Lactobacillus plantarum (BG 112) Lactobacillus sporogenes, Lactobacillus rhamnosus and Agave Inulin) Group 2: synbiotics with D-vitamin (Inulin, Lactobacillus rhamnosus, Lactobacillus plantarum, D3 Vitamin/Colecalciferol, Lactobacillus bulgaricus, Lactobacillus paracasei, Lactobacillus lactis) Group 3: prebiotics (agave inulin) Group 4: None
Duration: The intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period.
At the beginning of the study and at the end of the 4-month period, participants will undergo cognitive assessments using the CERAD neuropsychological battery. Additionally, blood and stool samples will be collected to analyze inflammation markers.
- Conditions
- Chemobrain, Breast Cancer, Inflammatory Disease
- Being tested
- Synbiotics Blend, Synbiotics + Vitamin D, Prebiotic
- Medical subject headings
- Chemotherapy-Related Cognitive Impairment, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotics BlendDietary supplement
Lactobacillus and inulin
Synbiotics + Vitamin DDietary supplement
Lactobacillus, inulin and colecalciferol.
PrebioticDietary supplement
Agave Inulin
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic | Active comparator | The intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period. Each participant will take one capsule daily.
Capsule: Lactobacillus acidophilus (LA3) Lactobacillus delbrueckii subsp. bulgaricus (SP 96) Lactobacillus casei (BGP 93) Lactobacillus plantarum (BG 112) Lactobacillus sporogenes, Lactobacillus rhamnosus and Agave Inulin) Receives: Dietary Supplement: Synbiotics Blend |
| Synbiotic with vitamin D3 | Active comparator | The intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period. Each participant will take one capsule daily.
Capsule: Inulin, Lactobacillus rhamnosus, Lactobacillus plantarum, D3 Vitamin/Colecalciferol, Lactobacillus bulgaricus, Lactobacillus paracasei, Lactobacillus lactis) Receives: Dietary Supplement: Synbiotics + Vitamin D |
| Prebiotic | Active comparator | The intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period. Each participant will take one capsule daily.
Capsule: Agave inulin. Receives: Dietary Supplement: Prebiotic |
| No synbiotic/prebiotic | No intervention | Participants in this arm won't have an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological battery
Cognitive assessments using the CERAD neuropsychological battery.
Measured: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.
Secondary outcomes (2)
C-reactive Protein
Serum C-reactive Protein
Measured: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.
Calprotectin
Calprotectine in stool sample
Measured: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start27 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChemobrainStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Jalisciense de Cancerologia
- Sponsor type
- Other government
- Collaborators
- Instituto Tecnológico y de Estudios Superiores de Occidente, Instituto Oncológico Nacional, University of Guadalajara
- Responsible party
- Principal investigator, Jose Alfonso Cruz-Ramos, Instituto Jalisciense de Cancerologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465497
- Sponsor's protocol ID
- PRO-106-25
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Supplementation With Synbiotics and Prebiotics on Cognitive Decline Associated With Neoadjuvant Chemotherapy in First-line Patients With Breast Cancer at Stages IB to IIIC of Any Molecular Subtype.
- ClinicalTrials.gov ID
- NCT07465497
- Acronym / sponsor ID
- PRO-106-25
- Conditions
- Chemobrain, Breast Cancer, Inflammatory Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Instituto Jalisciense de CancerologiaOther government
- Collaborators
- Instituto Tecnológico y de Estudios Superiores de Occidente, Instituto Oncológico Nacional, University of Guadalajara
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 12 Mar 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.
The goal of this research protocol is to evaluate whether supplementation with: synbiotics (probiotics with agave inulin), synbiotics with vitamid D or prebiotics (agave inulin) can reduce cognitive decline in patients with breast cancer undergoing neoadjuvant chemotherapy. It will also assess the safety of these supplements. The main questions it aims to answer are:
Does supplementation with synbiotics and prebiotics decrease cognitive decline in participants? What adverse effects do participants experience while taking these supplements? Are there significant changes in inflammation markers (calprotectin and C-reactive protein) before and after treatment?
Participants will:
Receive either synbiotics, prebiotics or none daily for 4 months. Undergo cognitive assessments using the CERAD neuropsychological battery at the beginning and end of the study.
Provide blood and stool samples for analysis of inflammation markers. Report any adverse effects experienced during the supplementation period.
Detailed description
The primary aim of this research is to investigate the effects of supplementation with synbiotics and prebiotics on cognitive decline in patients diagnosed with breast cancer who are undergoing neoadjuvant chemotherapy.
This study will utilize a double-blind, randomized design. Group 1: synbiotics (Lactobacillus acidophilus (LA3) Lactobacillus delbrueckii subsp. bulgaricus (SP 96) Lactobacillus casei (BGP 93) Lactobacillus plantarum (BG 112) Lactobacillus sporogenes, Lactobacillus rhamnosus and Agave Inulin) Group 2: synbiotics with D-vitamin (Inulin, Lactobacillus rhamnosus, Lactobacillus plantarum, D3 Vitamin/Colecalciferol, Lactobacillus bulgaricus, Lactobacillus paracasei, Lactobacillus lactis) Group 3: prebiotics (agave inulin) Group 4: None
Duration: The intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period.
At the beginning of the study and at the end of the 4-month period, participants will undergo cognitive assessments using the CERAD neuropsychological battery. Additionally, blood and stool samples will be collected to analyze inflammation markers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Synbiotic | Active comparator | Dietary Supplement: Synbiotics BlendThe intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period. Each participant will take one capsule daily. Capsule: Lactobacillus acidophilus (LA3) Lactobacillus delbrueckii subsp. bulgaricus (SP 96) Lactobacillus casei (BGP 93) Lactobacillus plantarum (BG 112) Lactobacillus sporogenes, Lactobacillus rhamnosus and Agave Inulin) |
| Synbiotic with vitamin D3 | Active comparator | Dietary Supplement: Synbiotics + Vitamin DThe intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period. Each participant will take one capsule daily. Capsule: Inulin, Lactobacillus rhamnosus, Lactobacillus plantarum, D3 Vitamin/Colecalciferol, Lactobacillus bulgaricus, Lactobacillus paracasei, Lactobacillus lactis) |
| Prebiotic | Active comparator | Dietary Supplement: PrebioticThe intervention will last for a total of 4 months, coinciding with the chemotherapy treatment period. Each participant will take one capsule daily. Capsule: Agave inulin. |
| No synbiotic/prebiotic | No intervention | –Participants in this arm won't have an intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: Participants must be between 18 and 75 years old.
- Diagnosis: Must have a confirmed diagnosis of breast cancer at stages IB to IIIC.
- Treatment Status: Participants should be scheduled to receive neoadjuvant chemotherapy as part of their treatment plan.
- Cognitive Function: Must demonstrate baseline cognitive function as assessed by the CERAD neuropsychological battery, indicating no severe cognitive impairment.
- Informed Consent: Participants must provide written informed consent to participate in the study and comply with all study procedures.
Key exclusion criteria (7 listed)
- Severe Cognitive Impairment: Participants with significant cognitive impairment or dementia as assessed by the CERAD neuropsychological battery will be excluded.
- Severe Comorbidities: Participants with serious comorbid conditions, such as uncontrolled diabetes, severe cardiovascular diseases, or active infections, will be excluded.
- Psychiatric Disorders: Individuals with a history of severe psychiatric disorders that could affect cognitive function or compliance with the study protocol will be excluded.
- Neurological Conditions: Participants with neurological disorders such as multiple sclerosis, Parkinson's disease, or other conditions that affect cognitive function will be excluded.
- Pregnant or Lactating Women: Pregnant or breastfeeding women will not be eligible to participate in the study.
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 |
|---|---|---|
| Synbiotics BlendLactobacillus and inulin | Dietary supplement | Synbiotic |
| Synbiotics + Vitamin DLactobacillus, inulin and colecalciferol. | Dietary supplement | Synbiotic with vitamin D3 |
| PrebioticAgave Inulin | Dietary supplement | Prebiotic |
Primary outcome
Neuropsychological battery
Time frame: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.
Cognitive assessments using the CERAD neuropsychological battery.
2 secondary outcomes
C-reactive Protein
Time frame: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.
Calprotectin
Time frame: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.
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 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Synbiotics Blend, Synbiotics + Vitamin D and Prebiotic in people with Chemobrain and Breast Cancer, run by Instituto Jalisciense de Cancerologia at 1 site in Mexico.
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 7 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 12 Mar 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 Mexico. 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?
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?
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?
Neuropsychological battery (time frame: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.). 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 12 Mar 2026.