Impact of Supplementation With Synbiotics and Prebiotics on Cognitive Decline Associated With Neoadjuvant Chemotherapy in First-line Patients With Breast Cancer

March 6, 2026 updated by: Jose Alfonso Cruz-Ramos, Instituto Jalisciense de Cancerologia

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?

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Zapopan, Jalisco, Mexico, 44660
        • Instituto Oncológico Nacional

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Synbiotic

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)
Dietary supplement: Synbiotics Blend
Lactobacillus and inulin
Active Comparator: Synbiotic with vitamin D3

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)
Dietary supplement: Synbiotics + Vitamin D
Lactobacillus, inulin and colecalciferol.
Active Comparator: Prebiotic

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.
Dietary supplement: Prebiotic
Agave Inulin
No Intervention: No synbiotic/prebiotic
Participants in this arm won't have an intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive Protein
Time Frame: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.
Serum C-reactive Protein
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.
Calprotectine in stool sample
Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Jalisciense de Cancerologia

Collaborators

University of Guadalajara
Instituto Tecnológico y de Estudios Superiores de Occidente
Instituto Oncológico Nacional

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-106-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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