Each participant performed nasal saline irrigation at 2 periods:
Day -14 to Day 0
Day 14 to Day 28

Each participant performed Probiotic lactococcus lactis W136 nasal irrigation from Day 0 to D14

Chronic Rhinosinusitis

Nasal and sinus irrigation with reconstituted live probiotic bacteria

Topical probiotic treatment with Lactococcus lactis W136

Nasal and sinus irrigation with saline solution

Saline irrigation

Centre Hospitalier de l'Université de Montréal (CHUM)

Safety and Efficacy of Lactococcus Lactis Probiotic Bacteria for the Treatment of Chronic Rhinosinusitis

Subjective symptoms of nasal function.
The sino-nasal symtom score (SNSS) is the sum of the following nasal and sinus symptoms:
Nasal obstruction
Facial pain
Need to blow nose
Headache
Post-nasal drip
Each individual item is scored on a 0-3 ordinal scale, with a higher score indicating a worst/more severe symptom. The TNSS is the sum of the five symptoms and has a range of 0-15. A lower score is better.

SNOT-22 validated disease - specific quality of life score. The Sino-Nasal Outcome Test is a validated, disease specific quality of life questionnaire. It contains 22 items, which contributes to the SNOT-22 acronym. Each of the individual items is scored on a 0-5 ordinal score. A higher score indicate worst quality of life. Individual results are summed with equal weight. The sum is the SNOT-22 score, which has a range of 0-110. A lower score is better.

Validated endoscopic scoring system. The Perioperative Sinus Endoscopy score assesses the condition of the sinuses and sinus mucosa as assessed with direct endoscopic visualization of the sinus passages. Presence of oedema, polyps, scarring and nasal secretions, and status of the principal sinus drainage passages (frontal and sphenoid), are assessed on a 0-2 ordinal scale. A higher score indicate worse disease.
POSE score is determined as the sum of each of the individual items and has a range of 0-12.

Swab culture for monitoring of infection/probiotic over growth

Centre hospitalier de l'Université de Montréal (CHUM)

McGill University

Rituximab 375 mg/m2 by vein. Cyclophosphamide (CTX) 300 mg/m2 by vein. Doxorubicin 50 mg/m2 by vein. Vincristine 2 mg by vein. Dexamethasone 40 mg by vein or by mouth (P.O.). Methotrexate (MTX) 12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7 - 200 mg/m2 by vein followed by 800 mg/m2 for Courses 2,4,6,8. Cytarabine 100 mg intrathecal for Courses 1,3,5,7 - 3 gm/m2 by vein for Courses 2,4,6,8. G-CSF 10 ug/kg subcutaneous injection. Mesna 600 mg/m2 a day by vein. Pegylated asparaginase 2000 International units/m2 by vein. Pegfilgrastim 6 mg (flat dose) within 72 hrs after completion of chemotherapy. Solumedrol 40 mg by vein for Courses 2,4,6,8.

Leukemia

Acute Lymphoblastic Leukemia

Rituximab

Cyclophosphamide (CTX)

Doxorubicin

Vincristine

Dexamethasone

12 mg intrathecally (6 mg if via Ommaya reservoir) for Courses 1,3,5,7
200 mg/m2 by vein followed by 800 mg/m2 for Courses 2,4,6,8

Methotrexate (MTX)

100 mg intrathecal for Courses 1,3,5,7
3 gm/m2 by vein for Courses 2,4,6,8

Cytarabine

G-CSF

Mesna

Pegylated asparaginase

6 mg (flat dose) within 72 hrs after completion of chemotherapy

Pegfilgrastim

Solumedrol

UT MD Anderson Cancer Center

Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia

Phase II Study of The Modified Hyper-CVAD Program for Acute Lymphoblastic Leukemia

ALL Response: Complete remission (CR) - Normalization peripheral blood & bone marrow 5% or < blasts in normocellular or hypercellular marrow granulocyte count of 1 x 109/L or > & platelet count >100 x 109/L. CR with incomplete platelet recovery (CRp)- per CR but platelet count <100 x 109/L. CR with incomplete recovery (CRi) - per CR but platelet count <100 x 109/L or absolute neutrophil count < 1 x 109/L. Partial response (PR) - As above except for presence of 6-25% marrow blasts. Lymphoblastic lymphoma (& ALL subtypes with extramedullary disease): CR - disappearance of all known disease. PR - >50% decrease in tumor size using sum of product, includes 50% volume decrease in lesions measurable in 3 dimensions. No Response (NR) - No significant change (includes stable disease). Lesions decreased size but <50% or lesions with slight enlargement <25% increase in size. Progressive Disease (PD) - Appearance of new lesions, 25% or > increase in size existing lesions (>50% if 1 lesion & <2).

M.D. Anderson Cancer Center

Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.

Hyper-CVAD + Imatinib

Sex: Female, Male

Region of Enrollment

Complete Remission (CR): Defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count of 1.0 × 109/L or higher and a platelet count of 100 × 109/L and no extramedullary disease.
Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.
Molecular CR: Same as for CR with RT-PCR negativity for bcr-abl.
Induction Death: Defined as death occurring after start of therapy without meeting the definition of CR or resistant disease.

Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate

Overall survival (OS) was calculated from the date of initiation of therapy until death.

Overall Survival Rate at 2-year and 5-year.

Disease-Free Survival (DFS) was calculated from the time of complete remission until relapse or death due to any cause.

Disease-Free Survival Rate at 2-year and 5-year.

Overall Study

Naval Daver, MD/Leukemia

600 mg by mouth on days 1 - 14 for course 1, and 600 mg by mouth daily days 1-14 (or daily if tolerated with course 1) for courses 2, 4, 6, 8.

Imatinib Mesylate

300 mg/m^2 by vein every 12 hours for 6 doses days 1, 2, 3 (total dose 1800 mg/m^2) for courses 1, 3, 5, 7.

Cyclophosphamide

50 mg/m^2 by vein on day 4 after last dose of CTX for courses 1, 3, 5, 7.

2 mg by vein on day 4 and day 11 for courses 1, 3, 5, 7.

40 mg by vein or by mouth daily on days 1 - 4 and days 11 - 14 for courses 1, 3, 5, 7.

12 mg intrathecally (6 mg if via Ommaya reservoir) day 2 for courses 1, 3, 5, 7.
200 mg/m^2 by vein over 2 hours followed by 800 mg/m^2 over 22 hours on day 1 of courses 2, 4, 6, 8.

Methotrexate

100 mg intrathecally day 7 for courses 1, 3, 5, 7.
3 gm/m2 by vein over 2 hrs every 12 hrs for 4 doses on days 2 and 3 for courses 2, 4, 6, 8.

600 mg/m^2 by vein daily for 24 hours for courses 1, 3, 5, 7.

10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.

University of Texas MD Anderson Cancer Center Website

antidote/dental caries

Safety and Efficacy of Lactococcus Lactis Probiotic Bacteria for the Treatment of Chronic Rhinosinusitis

Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia

Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia

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