Multiple MyelomaHCTDietNCT04629430
Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT
A study testing Pre-biotic foods/drinks in people with Multiple Myeloma and Acute Myeloid Leukemia, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to see whether hematopoietic stem cell transplant (HSCT) patients can consistently eat a diet rich in prebiotics. This type of diet may be helpful in maintaining diversity in the gastrointestinal (GI) system and therefore potentially decreasing risk of other GI problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
- What is being tested?
- Pre-biotic foods/drinks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2021to 28 Oct 2022
- 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
- Agreement to adhere to Lifestyle Considerations(prebiotic diet) throughout study duration
- Adults (≥18 yrs of age)
- Able to provide informed consent
- Are willing/able to incorporate the required foods in their diet
- Eligible, suitable and planning to undergo a stem cell transplant:
- Either allogeneic or autologous
- With any conditioning regimen (e.g. both myeloablative and reduced intensity conditioning)
- Matched related, matched unrelated, haplo-identical and cord blood transplants will be included.
Who cannot join
- Patients undergoing a second allogeneic or autologous transplant or an allogeneic transplant after an autologous transplant.
- Anticipation of requirement of broad spectrum antibiotics 1 week prior to admission for HSCT (through HSCT)
- Patients with any prior history of C.Diff infection
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
Official title: Effects of Prebiotics on Gut Microbiome in Patients Undergoing Stem Cell Transplants
The purpose of this study is to see whether hematopoietic stem cell transplant (HSCT) patients can consistently eat a diet rich in prebiotics. This type of diet may be helpful in maintaining diversity in the gastrointestinal (GI) system and therefore potentially decreasing risk of other GI problems.
Read the detailed description
Maintaining gastrointestinal (GI) microbiome diversity has been shown to improve treatment related mortality in HSCT patients. Interventions to improve GI microbial diversity could be beneficial to this patient population. Diets rich in prebiotics have been shown to increase gut microbial diversity and improve symptoms in other gastrointestinal diseases. Prebiotics are non-digestible carbohydrates that promote growth of commensal organisms in the gut by providing nutrition. Some examples are brown rice, green apples, and tomatoes. Our theory is that consuming a diet rich in prebiotics pre- and during the first 100 days following HSCT will help to reduce acute graft versus host disease (aGVHD) overall, and specifically acute GI GVHD, and clostridium difficile (C.Diff). Participants will be encouraged to eat at least 2 servings of a prebiotic-rich food from time of admission for HSCT through 100 days following HSCT and will be clinically monitored, including for acute GVHD, acute GI GVHD and C.Diff. Stool samples will be collected from all participants about once every 4 weeks.
- Conditions
- Multiple Myeloma, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Non Hodgkin Lymphoma, Acute Lymphocytic Leukemia, Hodgkin Lymphoma
- Being tested
- Pre-biotic foods/drinks
- Keywords
- hematopoietic stem cell transplant, stem cell transplant, bone marrow transplant, GI microbiome
- Medical subject headings
- Multiple Myeloma, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Hodgkin Disease, Primary Myelofibrosis, Myelodysplastic Syndromes, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-biotic foods/drinksOther
2 servings per day
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic diet | Experimental | 2 servings a day of pre-biotics every day from start of conditioning regimen for HSCT through 100 days following HSCT Receives: Other: Pre-biotic foods/drinks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of participants ingesting the required diet
Frequency of participants reporting ingesting at least 2 servings of prebiotics on ≥ 80% of study days
Measured: From initiation of conditioning regimen for HSCT through 100 days following HSCT
Secondary outcomes (4)
Incidence and severity of acute GVHD (aGVHD) and acute GI GVHD
Stage and grade of aGVHD (allogeneic HSCT participants only)
Measured: Within the first 100 days following HSCT
Incidence of CDiff infection
Number of people diagnosed with CDiff during the time frame
Measured: Within the first 100 days following HSCT
Patient weight
Measured: From initiation of conditioning regimen for HSCT through 100 days following HSCT
Number of days to neutrophil engraftment
Absolute neutrophil count >1000 for 1 day or > 500 for 3 consecutive days
Measured: From initiation of conditioning regimen for HSCT through 100 days following HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start19 Feb 2021
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Indumathy Varadarajan, MD, University of Virginia
- Investigators
- Indumathy Varadarajan, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629430
- Sponsor's protocol ID
- HSR 200296
- Acronym
- HCTDiet
- Status last verified
- Jan 2023
- First submitted
- 10 Nov 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prebiotics on Gut Microbiome in Patients Undergoing Stem Cell Transplants
- ClinicalTrials.gov ID
- NCT04629430
- Acronym / sponsor ID
- HCTDiet / HSR 200296
- Conditions
- Multiple Myeloma, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Non Hodgkin Lymphoma, Acute Lymphocytic Leukemia, Hodgkin Lymphoma
- Keywords
- hematopoietic stem cell transplant, stem cell transplant, bone marrow transplant, GI microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 16 Nov 2020 (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.
The purpose of this study is to see whether hematopoietic stem cell transplant (HSCT) patients can consistently eat a diet rich in prebiotics. This type of diet may be helpful in maintaining diversity in the gastrointestinal (GI) system and therefore potentially decreasing risk of other GI problems.
Detailed description
Maintaining gastrointestinal (GI) microbiome diversity has been shown to improve treatment related mortality in HSCT patients. Interventions to improve GI microbial diversity could be beneficial to this patient population. Diets rich in prebiotics have been shown to increase gut microbial diversity and improve symptoms in other gastrointestinal diseases. Prebiotics are non-digestible carbohydrates that promote growth of commensal organisms in the gut by providing nutrition. Some examples are brown rice, green apples, and tomatoes. Our theory is that consuming a diet rich in prebiotics pre- and during the first 100 days following HSCT will help to reduce acute graft versus host disease (aGVHD) overall, and specifically acute GI GVHD, and clostridium difficile (C.Diff). Participants will be encouraged to eat at least 2 servings of a prebiotic-rich food from time of admission for HSCT through 100 days following HSCT and will be clinically monitored, including for acute GVHD, acute GI GVHD and C.Diff. Stool samples will be collected from all participants about once every 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prebiotic diet | Experimental | Other: Pre-biotic foods/drinks2 servings a day of pre-biotics every day from start of conditioning regimen for HSCT through 100 days following HSCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Agreement to adhere to Lifestyle Considerations(prebiotic diet) throughout study duration
- Adults (≥18 yrs of age)
- Able to provide informed consent
- Are willing/able to incorporate the required foods in their diet
- Eligible, suitable and planning to undergo a stem cell transplant:
Key exclusion criteria (3 listed)
- Patients undergoing a second allogeneic or autologous transplant or an allogeneic transplant after an autologous transplant.
- Anticipation of requirement of broad spectrum antibiotics 1 week prior to admission for HSCT (through HSCT)
- Patients with any prior history of C.Diff infection
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 |
|---|---|---|
| Pre-biotic foods/drinks2 servings per day | Other | Prebiotic diet |
Primary outcome
Frequency of participants ingesting the required diet
Time frame: From initiation of conditioning regimen for HSCT through 100 days following HSCT
Frequency of participants reporting ingesting at least 2 servings of prebiotics on ≥ 80% of study days
4 secondary outcomes
Incidence and severity of acute GVHD (aGVHD) and acute GI GVHD
Time frame: Within the first 100 days following HSCT
Incidence of CDiff infection
Time frame: Within the first 100 days following HSCT
Patient weight
Time frame: From initiation of conditioning regimen for HSCT through 100 days following HSCT
Number of days to neutrophil engraftment
Time frame: From initiation of conditioning regimen for HSCT through 100 days following HSCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Indumathy Varadarajan principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-biotic foods/drinks in people with Multiple Myeloma and Acute Myeloid Leukemia, run by University of Virginia at 1 site in United States.
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 8 inclusion and 3 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: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of participants ingesting the required diet (time frame: From initiation of conditioning regimen for HSCT through 100 days following HSCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2023.