Clinical trial · Observational
Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction
The Role of Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction Chemotherapy
- 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)
This is an observational study to collect stool, blood, and urine from acute leukemia patients undergoing induction chemotherapy in order to generate preliminary data regarding the association between microbiota and chemotherapy-induced gut barrier damage. This study consists of inpatient collections of blood, urine, and stool while the patients are undergoing inpatient induction therapy. Patients will not be scheduled for any additional procedures or testing beyond what is required for clinical care.
Conditions
Conditions (2)
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 Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Chemotherapy-Induced Gut Barrier Damage | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational: Blood Sample Collection | Diagnostic Test | — | UNRESOLVED |
| Observational: Stool Sample Collection | Diagnostic Test | — | UNRESOLVED |
| Observational: Urine Sample Collection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- AL Patients Undergoing Induction Chemotherapy
- description
- Adults undergoing inpatient induction chemotherapy for newly diagnosed/relapsed acute leukemia.
- interventionNames
- Diagnostic Test: Observational: Stool Sample Collection
- Diagnostic Test: Observational: Blood Sample Collection
- Diagnostic Test: Observational: Urine Sample Collection
Primary outcomes (1)
- measure
- Variation of Gut Microbiota Composition and Diversity
- timeFrame
- Three times weekly until day 28 of chemotherapy.
- description
- Variation of gut microbiota composition and diversity, as determined by 16s rRNA sequencing of serial stool samples, during induction chemotherapy in acute leukemia patients.
Secondary outcomes (1)
- measure
- Variation of Gut Barrier Integrity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Adults (ages 18 - 99 years) undergoing inpatient induction chemotherapy for newly diagnosed or relapsed acute leukemia (myeloid or lymphoblastic). * Any induction regimen (standard or experimental) with planned \~4 weeks of inpatient stay * Able to provide written voluntary consent before performance of any study related procedure.
References
Publications (2)
- DERIVEDRashidi A, Ebadi M, Rehman TU, Elhusseini H, Halaweish HF, Kaiser T, Holtan SG, Khoruts A, Weisdorf DJ, Staley C. Lasting shift in the gut microbiota in patients with acute myeloid leukemia. Blood Adv. 2022 Jun 14;6(11):3451-3457. doi: 10.1182/bloodadvances.2021006783. PMID 35192686
- DERIVEDRashidi A, Ebadi M, Rehman TU, Elhusseini H, Nalluri H, Kaiser T, Ramamoorthy S, Holtan SG, Khoruts A, Weisdorf DJ, Staley C. Altered microbiota-host metabolic cross talk preceding neutropenic fever in patients with acute leukemia. Blood Adv. 2021 Oct 26;5(20):3937-3950. doi: 10.1182/bloodadvances.2021004973. PMID 34478486