Trial reportBreast (Edinburgh, Scotland)2023
Efficacy of probiotics and trimebutine maleate for abemaciclib-induced diarrhea: A randomized, open-label phase II trial (MERMAID, WJOG11318B).
Trial report in Breast (Edinburgh, Scotland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.
- Impact of CDK4/6 inhibitors on health-related quality of life outcomes in patients with metastatic breast cancer: A systematic review and meta-analysis.Journal of managed care & specialty pharmacy · 2025Pooled it
- Multidisciplinary Practical Guidance for Implementing Adjuvant CDK4/6 Inhibitors for Patients with HR-Positive, HER2-Negative Early Breast Cancer in Canada.Current oncology (Toronto, Ont.) · 2025Guideline
- Effectiveness of PsychobioticNutrients · 2024Trial
- A mixed prebiotic/probiotic intervention (MBR-01) for the management of diarrhea during abemaciclib treatment of early breast cancer in postmenopausal patients: A single-center prospective case-control pilot study.Breast (Edinburgh, Scotland) · 2026Article
- Fecal metagenome and plasma metabolome analyses reveal changes in gut microbiota composition and plasma metabolites in rats with abemaciclib-induced diarrhea.BMC gastroenterology · 2026Article
- Esomeprazole plus trimebutine maleate improves symptoms, esophageal function, and acid control without increasing risks in elderly GERD: a real-world retrospective study.American journal of translational research · 2026Article
- Optimizing breast cancer chemotherapy by harnessing gut microbiota with insights from artificial intelligence.NPJ biofilms and microbiomes · 2025Review
- Poly-γ-glutamic acid alleviates slow transit constipation by regulating aquaporin and gut microbes.Scientific reports · 2025Article
- One of the Short-Chain Fatty Acids (SCFAs), Sodium Propionate, Can Reduce the Dosage of Sishen Pill in Regulating the Intestinal Microbiota in Diarrhea with Kidney-Yang Deficiency Syndrome.Journal of inflammation research · 2025Article
- Risk factors for adverse reactions caused by abemaciclib in breast cancer therapy.Frontiers in oncology · 2025Article
- Safety assessment of cyclin-dependent kinase 4/6 inhibitors and comparison of time to adverse events.PloS one · 2025Article
- Optimizing abemaciclib-induced diarrhea management in patients with breast cancer: a pragmatic 2-group study using a postbiotic microbiota stabilizer.The oncologist · 2024Observational
- Prebiotics and Probiotics for Gastrointestinal Disorders.Nutrients · 2024Review
- Sticking to the Rules: Outcome and Success Rate of Guideline-Based Diarrhea Management in Metastatic Breast Cancer Patients Treated with Abemaciclib.Journal of clinical medicine · 2023Article
- The dysfunction in intestinal microorganisms and enzyme activity as significant contributors to diarrhea with kidney-yang deficiency syndrome.Frontiers in microbiology · 2023Article
Corrections and comments
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Authors and funding
15 authors at 11 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAbemaciclib-induced diarrhea (AID) impairs quality of life (QOL) and treatment adherence in patients with breast cancer. Supportive treatment with loperamide is associated with constipation. We hypothesized that probiotics and trimebutine maleate (TM) would decrease the frequency of AID without causing constipation.
methodsHormone receptor-positive, human epidermal growth factor 2-negative advanced breast cancer patients were randomized into the probiotic Bifidobacterium (A) or probiotic Bifidobacterium and TM (B) groups. Endocrine therapy, Abemaciclib and probiotic Bifidobacterium three times a day for 28 days, was administered to both arms. Arm B was treated with TM upon the onset of diarrhea. The primary endpoint was the percentage of patients who experienced grade ≥2 diarrhea. The secondary endpoints were safety, frequency, and duration of all-grade diarrhea; frequency of emesis and constipation; usage of loperamide; and health-related QOL/patient-reported outcome during the study. We evaluated whether the primary endpoint of each arm exceeded the predetermined threshold.
resultsFifty-one patients completed treatment. Grade 2 diarrhea occurred in 52% and 50% of patients in Arm A and Arm B, respectively. One patient experienced grade 3 diarrhea in each arm. The median duration of grade2 diarrhea was 2 and 2.5day, and only one patient required dose reduction. Grade ≥2 constipation was observed in 4% of Arm A and 3.6% of Arm B.
conclusionsProbiotic Bifidobacterium or the combination of probiotic Bifidobacterium with TM did not decrease the incidence of grade 2 or greater diarrhea compared with historical control, although the grade 3 or greater diarrhea was reduced. CLINICAL
trial registrationjRCT (Japan registry of clinical trials). jRCTs031190154.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.