CancerNCT06088940
The Chemo-Gut Probiotic Trial for Cancer Survivors
A study testing Multistrain Probiotic in people with Cancer and Psychosocial Problem, run by University of Calgary.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Psychosocial Problem, Gastrointestinal Dysfunction
- What is being tested?
- Multistrain Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, female, and non-binary, any ethnicity
- Aged 18 years or older
- Diagnosed with hematological cancers (leukemia, Hodgkin's, and non-Hodgkin lymphoma), breast, osteosarcoma, Ewing's sarcoma, gynecological (cervical, endometrial), prostate, or testicular
- Stages I - IV, including metastatic if stable and off treatment
- Have received chemotherapy (with or without radiation, surgery, or hormone therapy)
- Have completed primary cancer treatments
Show all 12Show fewer
- Within 5 years from their final cancer treatments, with emphasis placed on recruiting those within the first year post-treatment
- Not currently pregnant or planning to become pregnant during the 12-week study
- 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
- Able to provide stool samples
- Fluent in English, and have access to a computer, smartphone, or tablet with internet access to complete questionnaires
- Provide written informed consent
Who cannot join
- Diagnosis of central nervous system tumor, or colorectal cancer
- Taken antibiotics and/or daily probiotic (including probiotic yogurt) within the 1 month prior to study participation
- Currently or previously receiving immunotherapy
- Diagnosed with irritable bowel syndrome or inflammatory bowel disease prior to being diagnosed with cancer
- Diagnosed with a developmental/cognitive delay prior to cancer (e.g. autism spectrum disorder, downs syndrome)
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
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
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:
Read more
- 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.
Read the detailed 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.
- Conditions
- Cancer, Psychosocial Problem, Gastrointestinal Dysfunction
- Being tested
- Multistrain Probiotic, Placebo
- Keywords
- Gut microbiome, Patient Reported Outcomes, Probiotics, Cancer survivor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multistrain ProbioticDietary supplement
The probiotic capsule contains Lactobacillus and Bifidobacterium strains, ingested orally once daily.
PlaceboOther
Placebo is composed of maltodextrin, that is an identically formulated and packaged inactive substance
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group (Group 1: Experimental intervention) | Experimental | Participants will be given a 12-week supply of the probiotic supplement and asked to take 1 capsule daily by mouth at the same time as their first meal of the day. Receives: Dietary Supplement: Multistrain Probiotic |
| Placebo Group (Group 2: Control condition) | Placebo comparator | Participants will be given a 12-week supply of the placebo capsules and asked to take 1 capsule daily by mouth at the same time as their first meal of the day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Secondary outcomes (10)
Effects of probiotic on Gas/Bloating symptoms
Endpoint: Effects of probiotics on: Gas/bloating Measure: PROMIS Gas and Bloating - Scale v1.1 13a
Measured: 12 weeks
Effects of probiotic on Diarrhea symptoms
Endpoint: Effects of probiotics on: Diarrhea Measure: PROMIS Diarrhea - Scale v1.0, 6a
Measured: 12 weeks
Effects of probiotic on Constipation symptoms
Endpoint: Effects of probiotics on: Constipation Measure: PROMIS constipation - Scale v1.0, 9a
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Effects of probiotic on cognitive function
Measure: PROMIS v2.0 - Cognitive Function; Scores range from 80 (high function) to 20 (severe dysfunction).
Measured: 12 weeks
Effects of probiotic on global health symptoms
Measure: PROMIS Global Health - Scale v1.2; Scores range from 80 (Excellent health) to 20 (Poor health).
Measured: 12 weeks
Probiotic effects on gut microbiota alpha diversity composition
Measure: Chao1, Shannon, and Simpson index for statistically significant differences in alpha diversity between groups
Measured: 12 weeks
Probiotic effects on gut microbiota beta diversity composition
Measure: Bray-Curtis index for statistically significant differences in beta diversity between groups
Measured: 12 weeks
Probiotic effects on gut microbiota differential taxonomic abundance
Measure: statistically significant differences in differential taxonomic abundance (ASV's) between groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start10 Nov 2023 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie M Deleemans, PhD, Study director, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088940
- Sponsor's protocol ID
- HREBA.CC-22-0289
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be published. Deidentified data will be made available to other researchers after primary data has been published and upon reasonable request to the PI.
Publications
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.
PubMed 31870331Deleemans 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.
PubMed 36583068Deleemans 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.
PubMed 34844479
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06088940
- Acronym / sponsor ID
- HREBA.CC-22-0289
- Conditions
- Cancer, Psychosocial Problem, Gastrointestinal Dysfunction
- Keywords
- Gut microbiome, Patient Reported Outcomes, Probiotics, Cancer survivor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 10 Nov 2023 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group (Group 1: Experimental intervention) | Experimental | Dietary Supplement: Multistrain ProbioticParticipants will be given a 12-week supply of the probiotic supplement and asked to take 1 capsule daily by mouth at the same time as their first meal of the day. |
| Placebo Group (Group 2: Control condition) | Placebo comparator | Other: PlaceboParticipants will be given a 12-week supply of the placebo capsules and asked to take 1 capsule daily by mouth at the same time as their first meal of the day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male, female, and non-binary, any ethnicity
- Aged 18 years or older
- Diagnosed with hematological cancers (leukemia, Hodgkin's, and non-Hodgkin lymphoma), breast, osteosarcoma, Ewing's sarcoma, gynecological (cervical, endometrial), prostate, or testicular
- Stages I - IV, including metastatic if stable and off treatment
- Have received chemotherapy (with or without radiation, surgery, or hormone therapy)
Key exclusion criteria (6 listed)
- Diagnosis of central nervous system tumor, or colorectal cancer
- Taken antibiotics and/or daily probiotic (including probiotic yogurt) within the 1 month prior to study participation
- Currently or previously receiving immunotherapy
- Diagnosed with irritable bowel syndrome or inflammatory bowel disease prior to being diagnosed with cancer
- Diagnosed with a developmental/cognitive delay prior to cancer (e.g. autism spectrum disorder, downs syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multistrain ProbioticThe probiotic capsule contains Lactobacillus and Bifidobacterium strains, ingested orally once daily. | Dietary supplement | Probiotic Group (Group 1: Experimental intervention) |
| PlaceboPlacebo is composed of maltodextrin, that is an identically formulated and packaged inactive substance | Other | Placebo Group (Group 2: Control condition) |
Primary outcome
Effects of probiotic on abdominal pain
Time frame: 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
Time frame: 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.
10 secondary outcomes
Effects of probiotic on Gas/Bloating symptoms
Time frame: 12 weeks
Effects of probiotic on Diarrhea symptoms
Time frame: 12 weeks
Effects of probiotic on Constipation symptoms
Time frame: 12 weeks
Effects of probiotic on anxiety symptoms
Time frame: 12 weeks
Effects of probiotic on Fatigue symptoms
Time frame: 12 weeks
Effects of probiotic on cognitive function
Time frame: 12 weeks
Effects of probiotic on global health symptoms
Time frame: 12 weeks
Probiotic effects on gut microbiota alpha diversity composition
Time frame: 12 weeks
Probiotic effects on gut microbiota beta diversity composition
Time frame: 12 weeks
Probiotic effects on gut microbiota differential taxonomic abundance
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Background: PubMed 31870331Deleemans 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.
- Background: PubMed 36583068Deleemans 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.
- Background: PubMed 34844479Deleemans 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.
- Individual participant dataSharing planned: Yes. The study protocol will be published. Deidentified data will be made available to other researchers after primary data has been published and upon reasonable request to the PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie M Deleemans, PhD study director
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing Multistrain Probiotic in people with Cancer and Psychosocial Problem, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda E Carlson, PhD (403-355-3207, l.carlson@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of probiotic on abdominal pain (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06088940, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.