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Studies

Interventional Not yet recruiting

NCT06088940 on ClinicalTrials.gov

The Chemo-Gut Probiotic Trial for Cancer Survivors

Official title: The Chemo-Gut Trial: A Double-blind Randomized Controlled Trial Investigating the Effects of a Multi-strain Probiotic on Gut Microbiota, Gastrointestinal Symptoms, and Psychosocial Health in Cancer Survivors

  • Sponsor: University of Calgary
  • Enrollment: 66 (Estimated)
  • Study start: 2023-11-10 (Estimated)
  • Primary completion: 2024-11-30 (Estimated)
  • Study completion: 2025-09-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Theoretical Framework: This line of research follows the NIH ORBIT model for intervention development. Briefly, the ORBIT model provides a generic, systematic framework that emphasizes using a set of studies to form a chain of evidence that ultimately indicates readiness for an efficacy trial. Study Design. Consistent with the National Institutes for Health (NIH) clinical trial phases for drug development, this study will fit into phase II, where investigators are focused on examining treatment effectiveness. A placebo-controlled randomized double-blinded study design is the gold standard for intervention research involving medications or natural health products, such as probiotics.
  • Masking: Double (Participant, Investigator)
  • PrimaryPurpose: Supportive Care

Brief Summary

Purpose: The goal of this clinical trial is to determine whether probiotics can reduce gastrointestinal and psychosocial symptoms in post-treatment cancer survivors by impacting the gut microbiome.

Objectives: The main questions the investigators aim to answer are:

* Does taking the probiotic reduce gastrointestinal (e.g. belly pain) and psychosocial (e.g. depressive symptoms, fatigue) symptoms, and impact the gut microbiome?
* What relationships exist between gut bacteria, gastrointestinal, and psychosocial symptoms?

Methods: The study team will investigate this by giving a group of adult post-treatment cancer survivors either a probiotic capsule (intervention) or placebo capsule (control) over 12 weeks. Investigators will then analyze the bacterial diversity in participants' stool samples before and after these 12 weeks to see how the bacterial composition changed due to the treatment. Surveys will be used to ask participants questions about their physical and mental health, including specific gastrointestinal and psychosocial symptoms.

Implications: Cancer recovery is tough enough, and to minimize treatment-related long-term effects through a simple probiotic capsule would immensely improve the well-being and health of survivors.

Conditions

  • Cancer
  • Psychosocial Problem
  • Gastrointestinal Dysfunction

Intervention / Treatment

  • Dietary Supplement: Multistrain Probiotic
  • Other: Placebo

Primary Outcome Measures

  • Effects of probiotic on abdominal pain (12 weeks)
    Endpoint: Clinically meaningful effects will be defined as reductions of 3 points or more from baseline scores of abdominal pain symptoms on PROMIS measures. Measure: PROMIS Belly Pain - Scale v1.0, 5a; Scores range from 20 to 80. Higher scores \>60 indicate more symptoms.
  • Effects of probiotic on depression symptoms (12 weeks)
    Endpoint: Clinically meaningful effects will be defined as reductions of 3 points or more from baseline scores of depression on PROMIS measures. Measure: PROMIS Ca Item Bank v1.0 - Emotional Distress - Depression questionnaire; Scores range from 20 to 80. Higher scores \>60 indicate more symptoms.

Study Officials