The Chemo-Gut Probiotic Trial for Cancer Survivors

Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06088940
• Other study ID #: HREBA.CC-22-0289
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2023
• Source: University of Calgary
• Contact: Linda E Carlson, PhD
• Phone: 403-355-3207
• Email: l.carlson[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background: Survivors of cancer experience chronic gastrointestinal (GI) and psychosocial health symptoms, and reduced gut microbial diversity. This may compromise survivors' long-term health and overall wellbeing. No studies have investigated probiotics for managing both GI and psychosocial symptoms together, or the composition of the gut microbiota in post-treatment cancer survivors. Aims: To investigate the effects of a probiotic vs. placebo on (i) abdominal pain and depressive symptoms (primary outcomes); (ii) (a) GI (i.e. gas/bloating, diarrhea, constipation) and psychosocial (i.e. anxiety, cognitive function, fatigue) symptoms, and general health; and (b) gut microbiota composition; (iii) relationships between bacteria, GI and psychosocial symptoms. Methods: This double-blinded, placebo-controlled, 2-arm, randomized trial will recruit N=66 participants allocated to the probiotic or placebo group for a 12-week trial. Adult survivors diagnosed with a solid tumour or blood cancer who have completed chemotherapy within the last 5 years, and show elevated GI or psychosocial symptoms will be included. The probiotic capsule contains Lactobacillus and Bifidobacterium strains, ingested orally once daily. Stool samples will be collected at baseline and week-12 and analyzed using GA-Map dysbiosis test and 16S rRNA gene sequencing. GI and psychosocial surveys will be completed at baseline, weeks 6 and 12. Descriptive statistics, frequencies, paired samples t-tests, linear mixed models, and Spearman's correlations analyses will be used. Implications: This study explores a novel, microbiota-based treatment for chronic GI and psychosocial symptoms in cancer survivors. These findings and commitment to patient-centred knowledge translation via creating patient materials (e.g. infographics, personal results summary) will enable patients to make informed decisions about their health.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: September 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Gastrointestinal Dysfunction
• Psychosocial Problem

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

References & Publications (3)

Deleemans 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. — View Citation

Deleemans 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. — View Citation

Deleemans 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationships between bacterial taxa and symptoms	Measure: Scores for symptom outcomes will be correlated with bacterial operational taxonomic units (ASVs) using Spearman's rho for non-parametric data	12 weeks
Primary	Effects of probiotic on abdominal pain	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.	12 weeks
Primary	Effects of probiotic on depression symptoms	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.	12 weeks
Secondary	Effects of probiotic on Gas/Bloating symptoms	Endpoint: Effects of probiotics on: Gas/bloating Measure: PROMIS Gas and Bloating - Scale v1.1 13a	12 weeks
Secondary	Effects of probiotic on Diarrhea symptoms	Endpoint: Effects of probiotics on: Diarrhea Measure: PROMIS Diarrhea - Scale v1.0, 6a	12 weeks
Secondary	Effects of probiotic on Constipation symptoms	Endpoint: Effects of probiotics on: Constipation Measure: PROMIS constipation - Scale v1.0, 9a	12 weeks
Secondary	Effects of probiotic on anxiety symptoms	PROMIS Anxiety: v1.0 - Anxiety - Short Form 8a; Scores range from 20 to 80. Higher scores >60 indicate more symptoms.	12 weeks
Secondary	Effects of probiotic on Fatigue symptoms	PROMIS v1.0 - Fatigue - Short Form 8a. Scores range from 20 to 80. Higher scores >60 indicate more symptoms.	12 weeks
Secondary	Effects of probiotic on cognitive function	Measure: PROMIS v2.0 - Cognitive Function; Scores range from 80 (high function) to 20 (severe dysfunction).	12 weeks
Secondary	Effects of probiotic on global health symptoms	Measure: PROMIS Global Health - Scale v1.2; Scores range from 80 (Excellent health) to 20 (Poor health).	12 weeks
Secondary	Probiotic effects on gut microbiota alpha diversity composition	Measure: Chao1, Shannon, and Simpson index for statistically significant differences in alpha diversity between groups	12 weeks
Secondary	Probiotic effects on gut microbiota beta diversity composition	Measure: Bray-Curtis index for statistically significant differences in beta diversity between groups	12 weeks
Secondary	Probiotic effects on gut microbiota differential taxonomic abundance	Measure: statistically significant differences in differential taxonomic abundance (ASV's) between groups	12 weeks