Health TrialsbyHealthPanel

Probiotics for Abemaciclib-Induced Abdominal Discomfort.

ConditionsBreast CancerChemotherapy-induced Diarrhea
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeeuwenhoek Laboratories Co. Ltd.

About this trial

This study aims to evaluate whether the addition of probiotics can help reduce abdominal discomfort (such as diarrhea) in breast cancer patients receiving Abemaciclib treatment. Abemaciclib is an effective targeted therapy but often causes gastrointestinal side effects. While Loperamide is the standard treatment for diarrhea, this study explores if probiotics can provide additional relief and improve metabolic health.Participants will be randomly assigned to receive either probiotics or a placebo alongside their standard care. The study will monitor the frequency of abdominal symptoms and analyze blood samples to observe changes in metabolic factors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Absolute Neutrophil Count (ANC) ≥ 1,500/μL without G-CSF support within 14 days of enrollment.

Platelet count ≥ 100,000/μL.

Hemoglobin ≥ 8.0 g/dL (red blood cell transfusion is permitted prior to enrollment).

Serum alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 3× the upper limit of normal.

Disqualifiers

Severe renal impairment (e.g., estimated creatinine clearance < 30 mL/min).

Interstitial lung disease.

Severe dyspnea at rest or the requirement for oxygen therapy.

History of major gastrointestinal surgeries, such as gastrectomy or small bowel resection.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Synbiotic supplement followed by Placebo

    Dietary supplement

    The synbiotic supplement contains Bifidobacterium longum (probiotics), Oligonol® lychee polyphenol (prebiotics), and functional postbiotics. Participants will take two capsules daily for 2 months during the assigned study phase. This intervention is administered orally to evaluate its efficacy in alleviating Abemaciclib-induced abdominal discomfort.

  • Placebo followed by Probiotics

    Dietary supplement

    Participants in this sequence will receive the placebo for the first 2 months, followed by a 2-month period of receiving the synbiotic supplement (containing Bifidobacterium longum, lychee polyphenol, and postbiotics). All participants continue their prescribed Abemaciclib and endocrine therapy. Standard anti-diarrhea medication (Loperamide) is available as needed.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Synbiotic Supplement followed by PlaceboExperimental treatment 1 intervention
Group B: Placebo followed by Synbiotic SupplementPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Grade 2 or Higher Diarrhea

The primary endpoint is the proportion of patients experiencing Grade 2 or higher diarrhea, defined as an increase of 4 to 6 stools per day from baseline. This measure will compare the incidence between the experimental and control groups across each treatment cycle during the first two months.

Time frame
During the first 2 months of the intervention.

Secondary outcomes

1

Abemaciclib Dose Intensity

To compare the total administered dose of Abemaciclib between the synbiotic and placebo groups.

Time frame
4 months
2

Loperamide Utilization Rate

The total amount/dosage of standard anti-diarrhea medication (Loperamide) used by participants to manage GI symptoms.

Time frame
4 months
3

Total Duration of Diarrhea

The duration of diarrhea (any grade) experienced by participants during the 4-month study period.

Time frame
4 months
4

Duration of Grade 2 Diarrhea

The duration of Grade 2 diarrhea experienced by participants.

Time frame
4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Leeuwenhoek Laboratories Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov
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