Gut Decontamination In Pediatric Allogeneic Hematopoietic
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02641236|
Recruitment Status : Active, not recruiting
First Posted : December 29, 2015
Last Update Posted : May 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic Stem Cell Transplantation (HSCT) Acute GVH Disease||Drug: Vancomycin-polymyxin B||Phase 2|
This research study is a Phase 2 clinical trial. Phase 2 clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease.
"Investigational" means that the intervention is being studied.
Pre-clinical studies performed in the 1970's showed that killing all the bacteria in the intestine with oral antibiotics could decrease the risk of acute GVHD following allogeneic HSCT. Based on this observation, many stem cell transplant centers adopted the practice of "gut decontamination" with oral antibiotics as a preventive measure for acute GVHD. There is no standard regimen for gut decontamination between transplant centers, and there are no definitive human studies showing that gut decontamination is beneficial for lowering the risk of acute GVHD.
Recent studies in adult patients undergoing stem cell transplant indicate that the types of bacteria living in the intestine can influence bone marrow transplant outcomes such as survival and development of acute GVHD. Some types of bacteria may be protective against GVHD and others may increase the risk of GVHD. Based on this newer research, it is possible that the practice of gut decontamination ("vancopolys") may not be beneficial for HSCT patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase 2 Study to Examine the Impact of Gut Decontamination on Intestinal Microbiome Composition in Pediatric Allogeneic Hematopoietic Stem Cell Transplant Patients|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||May 2023|
Active Comparator: Gut Decontamination with vancopoly
Drug: Vancomycin-polymyxin B
No Intervention: No Gut Decontamination
- Gut Microbiome Description [ Time Frame: 2 Weeks post HSCT ]Shannon diversity index (range: 0-6), measured at 2 weeks post-HSCT.
- Stool Frequency [ Time Frame: 7 days post-HSCT ]
- Immune cell profiling: Absolute cell numbers of T-, B-, NK- and dendritic cell subsets by flow cytometry [ Time Frame: Performed prior to day -5 and at the post-transplant time points (1,2,3,6,9,12,18 and 24 months post-transplant) ]
- Presence of Acute GVHD [ Time Frame: Each stool collection time point after neutrophil engraftment until day +100 ]
- Overall Survival [ Time Frame: Time from randomization to death due to any cause, or censored at date last known alive. All participants will be followed for 2 years after study entry. ]
- Progression Free Survival [ Time Frame: Time from randomization to the earlier of progression of malignant disease or death due to any cause. All participants will be followed for 2 years after study entry. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641236
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Jennifer Whangbo, MD, PhD||Dana-Farber Cancer Institute|