Microbial ColonizationNCT04111471
The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients
A study testing Prebiotics in people with Microbial Colonization, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
This study will look at the effect of the prebiotic inulin compared to placebo on children undergoing stem cell transplant. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Prebiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2019to 18 Nov 2024
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 2-18 years
- Allogeneic Stem Cell transplant
- Myeloablative therapy
- Inpatient at Lurie Children's Hospital
Who cannot join
- Previous Hematopoietic Stem Cell Transplant
- Autologous Stem Cell Transplant
- Reduced Intensity Conditioning used for transplant
- History of ulcerative colitis, Crohn's disease, irritable bowel syndrome, celiac disease
- History of Type 1 or Type 2 Diabetes Mellitus
- Previous abdominal surgery necessitating the use of an ostomy
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- G-tube dependence
- Nasal gastric/oral gastric tube dependence prior to starting the conditioning process
- Graft vs host disease prior to enrollment at any site
- Children under 2 years of age - literature shows that the microbiome is still developing in children under two years of age, and this development may skew results
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: The Use of Inulin to Prevent Dysbiosis in Pediatric Hematopoietic Stem Cell Transplant Recipients
This study will look at the effect of the prebiotic inulin compared to placebo on children undergoing stem cell transplant.
Read the detailed description
Children enrolled in the study will receive either the prebiotic inulin or a placebo for 21 days during the study period. They will start taking the product seven days before transplant starts until 14 days after transplant. Stool will be collected twice weekly until thirty days after transplant or discharge, whichever occurs first. Stool samples will be sampled for metagenomic sequencing to identify the diversity of bacteria within the stool. They will also be analyzed for amount of short-chain fatty acid content (a breakdown product of inulin) as well as for presence of genes that confer antibiotic resistance. From 30 days after transplant until 100 days after transplant, two stool samples will be collected at regularly scheduled follow up appointments (near day 60 and day 100). No product (inulin or placebo) will be given during this time frame. The study period ends 100 days after transplant.
- Conditions
- Microbial Colonization
- Being tested
- Prebiotics, Placebos
- Keywords
- Microbiome, Prebiotic
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticsDietary supplement
Also called inulin
Enrolled patients will receive 10 grams of inulin daily for 21 days
PlacebosDietary supplement
Also called Maltodextrin
Enrolled patients will receive 5.6 grams of placebo powder daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | 20 patients will receive 5.6 g of placebo product (maltodextrin) daily for a total of 21 days (7 days before and until 2 weeks after transplant) Receives: Dietary Supplement: Placebos |
| Prebiotic (Inulin) Arm | Experimental | 20 patients will receive 10 g of inulin product daily for a total of 21 days (7 days before and until 2 weeks after transplant) Receives: Dietary Supplement: Prebiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alpha and beta bacterial diversity measures in stool
Compare the effect of oral inulin vs. placebo on alpha and beta bacterial diversity in the stool of children undergoing hematopoietic stem cell transplant
Measured: Change of baseline alpha and beta bacterial diversity at 100 days after transplant
Change in Short Chain Fatty Acid (SCFA) levels in stool
Compare the effect of oral inulin vs. placebo on SCFA levels in the stool of children undergoing hematopoietic stem cell transplant
Measured: Change in baseline SCFA levels in stool at 100 days after transplant
Secondary outcomes (1)
Bacterial Resistance genes in stool
Determine the impact of inulin intake vs. placebo on the prevalence of genes associated with antibiotic resistance of children undergoing hematopoietic stem cell transplant
Measured: Measured at enrollment, on the day of transplant, 30 days after transplant, and near 100 days after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start31 Oct 2019
- Primary completion18 Nov 2024
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Qualified patients that are admitted to Lurie Children's Hospital and agree to participate will either be randomized to receive the placebo or prebiotic, inulin. Randomization will occur 1:1
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehreen Arshad, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Mehreen M Arshad, MD, Principal investigator, Lurie Children's/Northwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111471
- Sponsor's protocol ID
- 2019-2801
- Status last verified
- Nov 2024
- First submitted
- 25 Jun 2019
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Inulin to Prevent Dysbiosis in Pediatric Hematopoietic Stem Cell Transplant Recipients
- ClinicalTrials.gov ID
- NCT04111471
- Acronym / sponsor ID
- 2019-2801
- Conditions
- Microbial Colonization
- Keywords
- Microbiome, Prebiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 1 Oct 2019 (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.
This study will look at the effect of the prebiotic inulin compared to placebo on children undergoing stem cell transplant.
Detailed description
Children enrolled in the study will receive either the prebiotic inulin or a placebo for 21 days during the study period. They will start taking the product seven days before transplant starts until 14 days after transplant. Stool will be collected twice weekly until thirty days after transplant or discharge, whichever occurs first. Stool samples will be sampled for metagenomic sequencing to identify the diversity of bacteria within the stool. They will also be analyzed for amount of short-chain fatty acid content (a breakdown product of inulin) as well as for presence of genes that confer antibiotic resistance. From 30 days after transplant until 100 days after transplant, two stool samples will be collected at regularly scheduled follow up appointments (near day 60 and day 100). No product (inulin or placebo) will be given during this time frame. The study period ends 100 days after transplant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Qualified patients that are admitted to Lurie Children's Hospital and agree to participate will either be randomized to receive the placebo or prebiotic, inulin. Randomization will occur 1:1
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Dietary Supplement: Placebos20 patients will receive 5.6 g of placebo product (maltodextrin) daily for a total of 21 days (7 days before and until 2 weeks after transplant) |
| Prebiotic (Inulin) Arm | Experimental | Dietary Supplement: Prebiotics20 patients will receive 10 g of inulin product daily for a total of 21 days (7 days before and until 2 weeks after transplant) |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 2-18 years
- Allogeneic Stem Cell transplant
- Myeloablative therapy
- Inpatient at Lurie Children's Hospital
Key exclusion criteria (10 listed)
- Previous Hematopoietic Stem Cell Transplant
- Autologous Stem Cell Transplant
- Reduced Intensity Conditioning used for transplant
- History of ulcerative colitis, Crohn's disease, irritable bowel syndrome, celiac disease
- History of Type 1 or Type 2 Diabetes Mellitus
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 |
|---|---|---|
| PrebioticsAlso: inulinEnrolled patients will receive 10 grams of inulin daily for 21 days | Dietary supplement | Prebiotic (Inulin) Arm |
| PlacebosAlso: MaltodextrinEnrolled patients will receive 5.6 grams of placebo powder daily for 21 days | Dietary supplement | Placebo Arm |
Primary outcome
Change in alpha and beta bacterial diversity measures in stool
Time frame: Change of baseline alpha and beta bacterial diversity at 100 days after transplant
Compare the effect of oral inulin vs. placebo on alpha and beta bacterial diversity in the stool of children undergoing hematopoietic stem cell transplant
Change in Short Chain Fatty Acid (SCFA) levels in stool
Time frame: Change in baseline SCFA levels in stool at 100 days after transplant
Compare the effect of oral inulin vs. placebo on SCFA levels in the stool of children undergoing hematopoietic stem cell transplant
1 secondary outcome
Bacterial Resistance genes in stool
Time frame: Measured at enrollment, on the day of transplant, 30 days after transplant, and near 100 days after transplant
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 21 Nov 2024.
- 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.
Mehreen M Arshad, MD principal investigator
Lurie Children's/Northwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotics in people with Microbial Colonization, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 4 inclusion and 10 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 21 Nov 2024. 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. 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?
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?
Change in alpha and beta bacterial diversity measures in stool (time frame: Change of baseline alpha and beta bacterial diversity at 100 days after transplant). 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?
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 21 Nov 2024.