The Chemo-Gut Probiotic Trial for Cancer Survivors

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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

1. Male, female, and non-binary, any ethnicity
2. Aged 18 years or older
3. Diagnosed with hematological cancers (leukemia, Hodgkin's, and non-Hodgkin lymphoma), breast, osteosarcoma, Ewing's sarcoma, gynecological (cervical, endometrial), prostate, or testicular
4. Stages I - IV, including metastatic if stable and off treatment
5. Have received chemotherapy (with or without radiation, surgery, or hormone therapy)
6. Have completed primary cancer treatments
7. Within 5 years from their final cancer treatments, with emphasis placed on recruiting those within the first year post-treatment
8. Not currently pregnant or planning to become pregnant during the 12-week study
9. Evidence of clinically elevated levels (i.e. a score of 56 or higher) of GI and/or comorbid psychosocial symptoms as determined using PROMIS short forms for abdominal pain, gas/bloating, and general mental and physical health
10. Able to provide stool samples
11. Fluent in English, and have access to a computer, smartphone, or tablet with internet access to complete questionnaires
12. Provide written informed consent

Exclusion Criteria:

1. Diagnosis of central nervous system tumor, or colorectal cancer
2. Taken antibiotics and/or daily probiotic (including probiotic yogurt) within the 1 month prior to study participation
3. Currently or previously receiving immunotherapy
4. Diagnosed with irritable bowel syndrome or inflammatory bowel disease prior to being diagnosed with cancer
5. Diagnosed with a developmental/cognitive delay prior to cancer (e.g. autism spectrum disorder, downs syndrome)
6. Pregnancy

• BACKGROUNDDeleemans JM, Chleilat F, Reimer RA, Henning JW, Baydoun M, Piedalue KA, McLennan A, Carlson LE. The chemo-gut study: investigating the long-term effects of chemotherapy on gut microbiota, metabolic, immune, psychological and cognitive parameters in young adult Cancer survivors; study protocol. BMC Cancer. 2019 Dec 23;19(1):1243. doi: 10.1186/s12885-019-6473-8. PMID 31870331
• BACKGROUNDDeleemans JM, Toivonen K, Reimer RA, Carlson LE. The Chemo-Gut Study: A Cross-Sectional Survey Exploring Physical, Mental, and Gastrointestinal Health Outcomes in Cancer Survivors. Glob Adv Health Med. 2022 Dec 21;11:2164957X221145940. doi: 10.1177/2164957X221145940. eCollection 2022. PMID 36583068
• BACKGROUNDDeleemans JM, Gajtani Z, Baydoun M, Reimer RA, Piedalue KA, Carlson LE. The Use of Prebiotic and Probiotic Interventions for Treating Gastrointestinal and Psychosocial Health Symptoms in Cancer Patients and Survivors: A Systematic Review. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211061733. doi: 10.1177/15347354211061733. PMID 34844479