![[Visit Client Website]](images/banner.gif)
Myeloablative regimens are associated with prolonged periods of cachexia/anorexia, nausea/vomiting, mucositis, and compromised gut integrity (CGI). Studies suggest that CGI could increase the risk of developing acute Graft versus Host Disease (aGVHD). Preserving gastrointestinal integrity may decrease the risk of aGVHD which occurs in approximately 35% of children undergoing allogeneic HCT. Probiotics (nutritional supplements that contain viable microorganisms and confer a benefit to the host) have emerged as a possible therapeutic agent in preserving gut integrity. Animal studies have found that administration of probiotics reduced the incidence of aGVHD when compared to placebo. Clinical trials in children with HIV infections and adults receiving organ transplants have found probiotics to reduce morbidity and mortality. Prior to our Pilot Trial, probiotics had not been investigated in the HCT setting. This pilot study evaluated the safety and feasibility of probiotics administered to children undergoing allogeneic HCT. Patients received once daily supplementation with L.plantarum 299v (1 x107 CFU/kg/day) beginning on Day – 7 and continued until Day + 14. Thirty-one patients who were undergoing myeloablative allogeneic HCT were enrolled. One patient was not evaluated for safety because only one dose was given and the patient withdrew from the study. Safety: Of 30 evaluable patients, there were no cases of Lactobacillus plantarum bacteremia (0% (0/30) with 95% exact binomial CI (0%, 12%)). Feasibility: Of the 31 eligible patients, only one (#12) received < 50% of the dose. Therefore, 97% of the eligible patients (30/31), 95% CI (83%-100%), received at least 50% of the probiotic dose. Clostridium difficile infections were noted in 20% of the patients by Day + 100. Non-lactobacillus bacteremia was noted in 23% of evaluable patients. Three patients died before Day + 100, but no deaths were associated with lactobacillus administration. Stage 1-3 acute Gastrointestinal aGVHD was noted in 22% of patients who survived to Day + 100. The overall incidence of Grades II-III GVHD was 26%. No patients had Grade 4 GVHD. Lactobacillus plantarum can safely and feasibly be administered to children undergoing myeloablative HCT.
| Evaluable Patients (N=30) |
Age at enrollment (years) |
|
Mean(SD) | 7.7 (4.7) |
Median (range) | 6.9 (2.2-17.3) |
Age at enrollment (years) |
|
2-3.99 | 10 (33%) |
4 or older | 20 (67%) |
Stem Cell Source |
|
Cord blood | 5 (16%) |
Marrow | 21 (70%) |
Marrow and cord blood | 1 (3%) |
PBSC | 3 (10%) |
Stage of Acute GI GVHD for patients alive through Day 100 |
|
0 | 21 (78%) |
1 | 2 (7%) |
2 | 1 (4%) |
3 | 3 (11%) |
Overall Grade of Acute GVHD for patients alive through Day 100 |
|
0 | 20 (74%) |
2 | 4 (15%) |
3 | 3 (11%) |