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Impact of Probiotics BIFILACT® on Diarrhea in Patients Treated With Pelvic Radiation

Phase 3
18 Years
Not Enrolling
Cancer, Diarrhea, Abdominal Pain, Quality of Life

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Trial Information

Impact of Probiotics BIFILACT® on Diarrhea in Patients Treated With Pelvic Radiation

This study was prospective, unicentric, controlled with comparison to a placebo, randomised
and double-blinded. Patients were stratified into three groups: prostatic cancers,
gynecologic cancers without chemotherapy and gynecologic or rectal cancers with

Patients were block-randomized by the research nurse and received a standard dose of
Bifilact® probiotics or placebo according to the random list generated by blocks of 2, 4, or
6 patients according to random permutations. A preliminary internal pilot study was
performed when the half of the expected sample size were recruited. The goal of this
analysis was to test assumptions that lead to chosen sample sizes (N0) and thus, validate
the feasibility of the study. Following preliminary results, the sample size re-calculated
at the interim analysis is similar to that originally intended. It would be advisable to
continue the recruitment as planned. No adjustment to the critical level of the test would
be required in analyzes carried out at the end of study. However, another random block
using higher probiotics dosage to the randomization was added with preservation of double
bind. New random list were generated for each strata with a 3:1:1 ratio (higher dose,
standard dose, placebo) to compensate for the starting of the latest higher dose group. All
the bottles had a similar aspect, they were all identified by the commercial brand Bifilact.
Also the group, either A, B or C, was circled on that bottle, depending on if that bottle
belong to the placebo group, standard dose group, or high dose group. Only the nurse knew
the coding system, it was also her who would assign the patient to a group, according to the
randomization list. She would also hand out the bottle to the patient every week. The two
registered dietician, caregivers, were totally excluded of this processes (preliminary study
and randomisation) to preserve the double blind.

Inclusion Criteria:

- They had a pelvic cancer: gynecologic, rectal, or prostatic,they were to receive
radiotherapy treatments for a minimum of 40 Gy at the pelvic level , with or without
chemotherapy and they had Eastern Cooperative Oncology Group(ECOG) performance status
of 0 or 1

Exclusion Criteria:

- they had previous radiotherapy treatments in the pelvic or abdominal region, medical
history of gastro-intestinal inflammation, malabsorption syndrome or inflammatory
bowel disease or coeliac disease, ileostomy, daily use of anti-diarrheal medication
before radiotherapy, pregnancy or breastfeeding, neutropenia or probiotics

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

testing the efficacy of probiotics Bifilact®, in comparison to a placebo to assess its ability to prevent or delay the incidence of moderate or severe symptoms of diarrhea during the period of treatment by radiotherapy

Outcome Description:

Patients were asked to note in a daily logbook whether they experienced digestive problems such as daily bowel movements. Severity of the diarrhea was evaluated according to toxicity criteria of the WHO: grade 1 = increase of 2-3 stools per day compared to pre-treatment, grade 2 = increase of 4-6 bowel stools per day or nocturnal stools, grade 3 = increase of 7-9 stools per day or incontinence, grade 4 = increase of 10 or more stools, need for IV hydration. The Registered Dietitian assessed symptoms in logbook with the patient once a week.The duration of daily logbook was 4-9 weeks depending of the total dose of external radiotherapy

Outcome Time Frame:

day 1-60

Safety Issue:


Principal Investigator

Dagnault Anne, PhD

Investigator Role:

Study Director

Investigator Affiliation:

CHU de Quebec


Canada: Ethics Review Committee

Study ID:



Start Date:

December 2006

Completion Date:

December 2010

Related Keywords:

  • Cancer
  • Diarrhea
  • Abdominal Pain
  • Quality of Life
  • Probiotics
  • radiation-induced enteritis
  • radiation-induced diarrhea
  • radiation, diarrhea, enteritis
  • diet
  • nutrition
  • Abdominal Pain
  • Diarrhea