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CancerPhase 3NCT01839721

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

A Phase 3 study testing Bifilact® in people with Cancer and Diarrhea, run by CHU de Quebec-Universite Laval at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Diarrhea, Abdominal Pain
What is being tested?
Bifilact®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
246 participants
Where
1 siteCanada
Study dates
Dec 2006to Dec 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • CHU de Québec, radio-oncology departement

    Québec, Quebec, G1R 2J6

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Bifilact®, placebo
Keywords
Probiotics, radiation-induced enteritis, radiation-induced diarrhea, radiation, diarrhea, enteritis, diet, nutrition
Medical subject headings
Neoplasms, Diarrhea, Abdominal Pain, Enteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bifilact®Drug

    Also called probiotics

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

  • placeboOther

Study groups in NCT01839721
Study groupRoleWhat they receive
Bifilact® probiotics standard doseActive comparatorconcentration 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
Receives: Drug: Bifilact®
Bifilact® probiotics high doseActive comparatorcontaining 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
Receives: Drug: Bifilact®
placeboPlacebo comparatorEach capsule contained maltodextrin and magnesium stearate as excipient. One pill twice a day
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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

    Measured: day 1-60

Secondary outcomes (5)

  1. Secondary objectives were to assess whether intake of Bifilact® lowered the interruption of radiotherapy treatments or doses of both radiotherapy or chemotherapy

    Registered Dietitian assessed respect of the preview protocol treatment each week (radiotherapy and chemotherapy) if not respected: diarrhea is it involved. For patients that received chemotherapy, a weekly blood profile was obtained and study pills were discontinued if neutrophil count became ≤1.5 X 10(9)/L.

    Measured: week 1-9

  2. Secondary objective were to assess whether intake of Bifilact® decreased or delayed the consumption of anti-diarrheal medication

    Patients were asked to note, each day during the treatment,in a daily logbook intake of anti-diarrheal medication, laxatives, and antibiotics. The Registered Dietitian assessed symptoms noted with the patient each week.The duration of daily logbook was 4-9 weeks depending of the total dose of external radiotherapy

    Measured: day 1-60

  3. Secondary objectives were to assess whether intake of Bifilact® reduced abdominal pain

    Abdominal pain was evaluated according to the NCI scale version 3.0: Grade 1 = mild pain, not interfering with function, grade 2 = moderate pain: pain or analgesics interfering with function, but not interfering with activity of daily living, grade 3 =: severe pain: pain or analgesics severely interfering with activity of daily living. The Registered Dietitian assessed information with the patient each week

    Measured: day 1-60

  4. Secondary objectives were to assess whether the overall well-being of patients was improved during treatment.

    Quality of life (EORTC-QLQ-C30) assessment was filled three times during the study: once at the outset, once at the end, and then again two weeks after the last radiotherapy treatment.

    Measured: week 0, 4-9, 6-11

  5. Secondary objectives were to assess whether intake of Bifilact® decreased need for hospitalization

    Registered Dietitian assessed each week if the patient had need hospitalization and if the diarrhea has involved

    Measured: week 1-9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2013 (estimated)
  2. Study startDec 2006
  3. Primary completionNov 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01839721
Sponsor's protocol ID
5.7.06.09
Status last verified
May 2013
First submitted
16 Apr 2013
Last updated
17 May 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24200199

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bifilact® in people with Cancer and Diarrhea, run by CHU de Quebec-Universite Laval at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 (time frame: day 1-60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01839721, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2013.

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