Clinical trial · Interventional
Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT
Effects of Prebiotics on Gut Microbiome in Patients Undergoing Stem Cell Transplants
NCT04629430CI-TRIAL-00063007HCTDietcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hodgkin Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myelofibrosis | Primary Myelofibrosis | ALIAS |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pre-biotic foods/drinks | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prebiotic diet
- description
- 2 servings a day of pre-biotics every day from start of conditioning regimen for HSCT through 100 days following HSCT
- interventionNames
- Other: Pre-biotic foods/drinks
Primary outcomes (1)
- measure
- Frequency of participants ingesting the required diet
- timeFrame
- From initiation of conditioning regimen for HSCT through 100 days following HSCT
- description
- Frequency of participants reporting ingesting at least 2 servings of prebiotics on ≥ 80% of study days
Secondary outcomes (4)
- measure
- Incidence and severity of acute GVHD (aGVHD) and acute GI GVHD
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Agreement to adhere to Lifestyle Considerations(prebiotic diet) throughout study duration 2. Adults (≥18 yrs of age) 3. Able to provide informed consent 4. Are willing/able to incorporate the required foods in their diet 5. Eligible, suitable and planning to undergo a stem cell transplant: 1. Either allogeneic or autologous 2. With any conditioning regimen (e.g. both myeloablative and reduced intensity conditioning) 3. Matched related, matched unrelated, haplo-identical and cord blood transplants will be included. Exclusion Criteria: 1. Patients undergoing a second allogeneic or autologous transplant or an allogeneic transplant after an autologous transplant. 2. Anticipation of requirement of broad spectrum antibiotics 1 week prior to admission for HSCT (through HSCT) 3. Patients with any prior history of C.Diff infection
References
Publications (0)
Data not yet available
No reference posted for this study.