Trial Search Results

Probiotic Supplementation in Preventing Treatment-Related Diarrhea in Patients With Cancer Undergoing Chemotherapy

This randomized phase II clinical trial studies probiotic supplementation in preventing treatment-related diarrhea in patients with cancer undergoing chemotherapy. Probiotics may help prevent diarrhea caused by treatment with chemotherapy.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):


  • Dietary Supplement: Lactobacillus plantarum strain 299v
  • Dietary Supplement: Lactobacillus acidophilus probiotic
  • Dietary Supplement: placebo
  • Other: laboratory biomarker analysis
  • Other: questionnaire administration
  • Procedure: quality-of-life assessment
  • Dietary Supplement: Bifidobacterium lactis probiotic supplement


Phase 2


Inclusion Criteria:

   - Any patient with a documented malignancy initiating treatment including (as a single
   agent or in combination with other drugs) any one of the following cancer

   o Fluorouracil (5FU), capecitabine, irinotecan, paclitaxel, docetaxel, cabazitaxel,
   crizotinib, sorafenib, sunitinib, erlotinib, or lapatinib

   - Any pathologically confirmed malignancy for which the patient would receive any of the
   listed cancer therapeutics

   - Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2

   - Patient must have an estimated life expectancy of at least 6 months

   - Absolute neutrophil count (ANC) > 1500

   - Platelets > 100K

   - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x ULN (upper
   limit normal)

   - Serum bilirubin < 1.5 x ULN

   - Serum creatinine < 1.5 x ULN

   - Ability to understand and the willingness to sign a written informed consent document
   and comply with the treatment protocol

Exclusion Criteria:

   - Patients currently undergoing treatment with the above listed therapeutics at time of
   initiation of trial; patients can have had prior treatment(s) with one or more of the
   agents if they are initiating a new treatment with another agent on the list, provided
   they have had at least a 2 week "washout" period

   - Patients currently taking anti-diarrheal medications or therapy

   - Patients undergoing hemodialysis

   - Patients with known allergic or hypersensitivity reaction to probiotics, yoghurt, or
   similar diet or supplemental products

   - Acute or chronic diarrhea, including lactose intolerance, gluten or other dietary
   sensitivity resulting in gastrointestinal symptoms

   - Pregnant or nursing patients

   - Known human immunodeficiency virus (HIV) positive

   - Prior abdominal surgery resulting in a stoma, ostomy, fistula, or other anatomic

   - Concurrent or near future radiotherapy; prior, completed radiotherapy allowed; any
   radiotherapy within the vicinity of the GI tract must have been completed at least 4
   weeks prior to start of trial

   - Treatment with any investigational drug within 4 weeks prior to enrollment

   - Current treatment with antibiotics or other gut motility agents within 2 weeks of
   starting study medication

   - Abnormal thyroid function that is not controlled with medication

   - Patients taking other dietary supplements within 2 weeks of starting study medication

   - Any other serious or uncontrolled illness which, in the opinion of the investigator,
   makes it undesirable for the patient to enter the trial

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Denise Haas