Bone Marrow Transplant - Autologous or AllogeneicNCT02470104
Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
A study testing Breastmilk in people with Bone Marrow Transplant - Autologous or Allogeneic, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The investigators hypothesize that children receiving human milk will maintain a greater diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in the blood compared with children not receiving human milk. Read more about this study
- Who is it for?
- Ages Up to 4 years
- Conditions the study is for
- Bone Marrow Transplant - Autologous or Allogeneic
- What is being tested?
- Breastmilk
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 4 May 2018
- 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 Up to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children less than 5 years old receiving transplant (autologous or allogeneic)
- Parents must give informed consent
Who cannot join
- Failure to meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: A Randomized Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
The investigators hypothesize that children receiving human milk will maintain a greater diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in the blood compared with children not receiving human milk.
Read the detailed description
The investigators hypothesize that the gut microbiota during bone marrow transplant could be influenced by administration of enteral donor breast milk. This study will attempt to address this hypothesis, by feeding donor breast milk to young children undergoing transplant, and serially comparing the gut microbiota in children receiving human milk, with those receiving conventional feeding.
- Being tested
- Breastmilk
- Keywords
- children, bone marrow transplant, autologous, allogeneic, breastmilk, hematopoietic stem cell transplantation (HSCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastmilkDietary supplement
- A registered dietician will supervise milk provision.
- If a nursing mother enrolls on the study, maternal and not donor milk will be given in the maximum volume possible with Prolacta supplementation if clinically indicated and recommended by the registered dietician.
| Study group | Role | What they receive |
|---|---|---|
| Enteral Donor Breastmilk | Experimental | * Donor milk will be pasteurized prior to use.
* Given orally or by nasogastric (NG) or nasojejunal (NJ) tube.
* Feeding will be supervised and will be advanced as quickly as tolerated with a goal of providing 40-50% of nutritional needs from the donor milk.
* It is recognized that the volume of enteral feeds will need to be adjusted per patient tolerance. Receives: Dietary Supplement: Breastmilk |
| Control | No intervention | • Children randomized to the control arm will receive standard enteral or parenteral nutrition per standard clinical practice, supervised by a registered dietician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of lactobacillales
Bar chart to indicate percentage of lactobacillales in stool samples.
Measured: 21 days after transplant
Secondary outcomes (3)
Pro-inflammatory cytokine level
Mean fold increase above baseline for the cytokine will be calculated and compared to control. Value will be tested for statistical significance using the Wilcoxon Rank Sum test.
Measured: weekly during study course; up to approximately one year
Incidence of bacteremia
Frequency of bacterial sepsis to be compared against controls.
Measured: though day 14 post transplant
Incidence of graft versus host disease (GVHD)
Frequency of GVHD will be compared to controls.
Measured: through study course; approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startMar 2015
- Primary completion25 May 2017
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow Transplant - Autologous or AllogeneicStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Prolacta Bioscience
- Responsible party
- Sponsor
- Investigators
- Stella Davies, MB.BS, PhD, MRCP, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470104
- Sponsor's protocol ID
- 2014-4127
- Status last verified
- Aug 2020
- First submitted
- 1 Apr 2015
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT02470104
- Acronym / sponsor ID
- 2014-4127
- Keywords
- children, bone marrow transplant, autologous, allogeneic, breastmilk, hematopoietic stem cell transplantation (HSCT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Prolacta Bioscience
- Study start
- Mar 2015
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 12 Jun 2015 (estimated)
- 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 investigators hypothesize that children receiving human milk will maintain a greater diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in the blood compared with children not receiving human milk.
Detailed description
The investigators hypothesize that the gut microbiota during bone marrow transplant could be influenced by administration of enteral donor breast milk. This study will attempt to address this hypothesis, by feeding donor breast milk to young children undergoing transplant, and serially comparing the gut microbiota in children receiving human milk, with those receiving conventional feeding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral Donor Breastmilk | Experimental | Dietary Supplement: Breastmilk* Donor milk will be pasteurized prior to use. * Given orally or by nasogastric (NG) or nasojejunal (NJ) tube. * Feeding will be supervised and will be advanced as quickly as tolerated with a goal of providing 40-50% of nutritional needs from the donor milk. * It is recognized that the volume of enteral feeds will need to be adjusted per patient tolerance. |
| Control | No intervention | –• Children randomized to the control arm will receive standard enteral or parenteral nutrition per standard clinical practice, supervised by a registered dietician. |
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children less than 5 years old receiving transplant (autologous or allogeneic)
- Parents must give informed consent
Key exclusion criteria (1 listed)
- Failure to meet inclusion criteria
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 |
|---|---|---|
| Breastmilk* A registered dietician will supervise milk provision. * If a nursing mother enrolls on the study, maternal and not donor milk will be given in the maximum volume possible with Prolacta supplementation if clinically indicated and recommended by the registered dietician. | Dietary supplement | Enteral Donor Breastmilk |
Primary outcome
Percentage of lactobacillales
Time frame: 21 days after transplant
Bar chart to indicate percentage of lactobacillales in stool samples.
3 secondary outcomes
Pro-inflammatory cytokine level
Time frame: weekly during study course; up to approximately one year
Incidence of bacteremia
Time frame: though day 14 post transplant
Incidence of graft versus host disease (GVHD)
Time frame: through study course; approximately one year
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 20 Aug 2020.
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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.
Stella Davies, MB.BS, PhD, MRCP principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastmilk in people with Bone Marrow Transplant - Autologous or Allogeneic, run by Children's Hospital Medical Center, Cincinnati 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 2 inclusion and 1 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 20 Aug 2020. 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?
Percentage of lactobacillales (time frame: 21 days after transplant). 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 20 Aug 2020.