An interventional study of Synbiotics Blend and Synbiotics + Vitamin D in Chemobrain, Breast Cancer and Inflammatory Disease, sponsored by Instituto Jalisciense de Cancerologia. Enrolling by invitation at 1 site in Mexico. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Instituto Jalisciense de Cancerologia · Not applicable, Interventional, and Supportive care
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.
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.
39 studies on the registry are indexed under Chemotherapy-Related Cognitive Impairment; 19 are open to participants now.
This study's planned enrollment of 80 is below the median of 95 across 30 interventional studies indexed under Chemotherapy-Related Cognitive Impairment.
Browse Chemotherapy-Related Cognitive Impairment studies →Instituto Jalisciense de Cancerologia is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Participants in this arm won't have an intervention.
Lactobacillus and inulin
Lactobacillus, inulin and colecalciferol.
Agave Inulin
Neuropsychological battery
Cognitive assessments using the CERAD neuropsychological battery.
Time frame: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.
C-reactive Protein
Serum C-reactive Protein
Time frame: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.
Calprotectin
Calprotectine in stool sample
Time frame: Before the first cicle of chemotherapy and intervention, and after the four months of cancer treatment and intervention.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.
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Studies of the drug tested here: Prebiotics
Chemotherapy-Related Cognitive Impairment →
Instituto Jalisciense de Cancerologia