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The Chemo-Gut Probiotic Trial for Cancer Survivors

NCT06088940 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-10-18

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Multistrain Probiotic

The probiotic capsule contains Lactobacillus and Bifidobacterium strains, ingested orally once daily.

OTHER

Placebo

Placebo is composed of maltodextrin, that is an identically formulated and packaged inactive substance

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Julie M Deleemans, PhD · University of Calgary Cumming School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2024-11-30
Completion
2025-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06088940 on ClinicalTrials.gov