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

NCT ID: NCT01839721

Last Updated: 2013-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2010-12-31

Brief Summary

In this double-blinded randomized clinical trial study, investigators assessed probiotic used to prevent or delay radiation induced grade moderate to severe diarrhea with patient treated for pelvic cancer.

Detailed Description

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 chemotherapy.

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.

Conditions

Cancer; Diarrhea; Abdominal Pain; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Bifilact® probiotics standard dose

concentration of 1.3 billion of Lactobacillus acidophilus LAC-361 and Bifidobacterium longum BB-536. one pill twice a day. Each capsule contained maltodextrin and magnesium stearate as excipient

Group Type: ACTIVE_COMPARATOR

Bifilact®

Intervention Type: DRUG

placebo, standard dose 1.3 billion twice a day, high dose 10 billion three time a day

Bifilact® probiotics high dose

containing 10 billion Lactobacillus acidophilus LAC-361 and Bifidobacterium longum BB-536. One pill three times a day. Each capsule contained maltodextrin and magnesium stearate as excipient

Group Type: ACTIVE_COMPARATOR

Bifilact®

Intervention Type: DRUG

placebo, standard dose 1.3 billion twice a day, high dose 10 billion three time a day

placebo

Each capsule contained maltodextrin and magnesium stearate as excipient. One pill twice a day

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Interventions

Bifilact®

placebo, standard dose 1.3 billion twice a day, high dose 10 billion three time a day

Intervention Type: DRUG

placebo

Intervention Type: OTHER

Other Intervention Names

probiotics

Eligibility Criteria

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 intolerance

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Mimi Demers

registered dietitian

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dagnault Anne, PhD

Role: STUDY_DIRECTOR

CHU de Quebec

Josee Desjardins, B.Sc, RD

Role: PRINCIPAL_INVESTIGATOR

Chu de Quebec

Mimi Demers, B.Sc. RD

Role: PRINCIPAL_INVESTIGATOR

CHU de Québec

Locations

CHU de Québec, radio-oncology departement

Québec, Quebec, Canada

Countries

Canada

References

Demers M, Dagnault A, Desjardins J. A randomized double-blind controlled trial: impact of probiotics on diarrhea in patients treated with pelvic radiation. Clin Nutr. 2014 Oct;33(5):761-7. doi: 10.1016/j.clnu.2013.10.015. Epub 2013 Oct 24.

Reference Type: DERIVED

PMID: 24200199 (View on PubMed)

Other Identifiers

5.7.06.09

Identifier Type: -

Identifier Source: org_study_id