Clinical trial · Interventional
Lactobacillus in Preventing Infection in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Myelodysplastic Syndrome
Probiotic Enteric Regimen For Easing Complications of Transplant : A Pilot Study (PERFECT Trial)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
RATIONALE: Probiotics, such as Lactobacillus, may be effective in preventing infections in patients with suppressed immune systems. PURPOSE: This phase I trial is studying the side effects and how well giving enteral nutrition, including Lactobacillus, works in preventing infections in patients undergoing donor stem cell transplant for hematologic cancer or myelodysplastic syndrome.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lactobacillus rhamnosus GG | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lactobacillus GG
- description
- Open label trial of Culturelle (Lactobacillus GG) administered to patients after engraftment, post allogeneic stem cell transplantation.
- interventionNames
- Dietary Supplement: Lactobacillus rhamnosus GG
Primary outcomes (1)
- measure
- Safety as indicated by the lack of infection attributable to probiotic organisms
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Currently undergoing allogeneic stem cell transplantation from a related or unrelated donor for a hematologic malignancy or myelodysplastic syndrome * Hematopoietic engraftment as evidenced by recovery of the absolute neutrophil count \> 1000/μL for \> 3 days without filgrastim (G-CSF) support within 30 days of transplant PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Serum creatinine ≤ 2.0 * AST or ALT ≤ 3 times upper limit of normal (ULN) * Total bilirubin ≤ 2.0 times ULN * No clostridium difficile enterocolitis diagnosed during the transplant hospitalization in the peri-transplant period * Able to take medications by mouth * No evidence of graft-vs-host disease * No history of inflammatory bowel disease or other chronic diarrheal illness * No history of hypersensitivity to milk proteins PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 3 months since prior use of probiotics supplements, excluding yogurt and cheeses with live cultures * No concurrent over-the-counter medications or herbal remedies
References
Publications (0)
Data not yet available