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

NCT01839721 | Completed Phase 3 DMC

• 1 other identifier: 5.7.06.09
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Diarrhea; Abdominal Pain; Quality of Life

Keywords

Probiotics; radiation-induced enteritis; radiation-induced diarrhea; radiation, diarrhea, enteritis; diet; nutrition

Outcome Measures

Primary Outcomes (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

  day 1-60

Secondary Outcomes (5)

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

  week 1-9

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

  day 1-60

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

  day 1-60

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

  week 0, 4-9, 6-11

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

  week 1-9

Study Arms (3)

Bifilact® probiotics standard dose

ACTIVE COMPARATOR

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

Drug: Bifilact®

Bifilact® probiotics high dose

ACTIVE COMPARATOR

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

Drug: Bifilact®

placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

Bifilact® DRUG

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

Also known as: probiotics

Bifilact® probiotics high dose; Bifilact® probiotics standard dose

placebo OTHER

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

CHU de Québec, radio-oncology departement

Québec, Quebec, G1R 2J6, Canada

Location

Related Publications (1)

• 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.

  PMID: 24200199 DERIVED

MeSH Terms

Conditions

Neoplasms; Diarrhea; Abdominal Pain; Enteritis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dagnault Anne, PhD

  CHU de Quebec

  STUDY DIRECTOR

• Josee Desjardins, B.Sc, RD

  Chu de Quebec

  PRINCIPAL INVESTIGATOR

• Mimi Demers, B.Sc. RD

  CHU de Québec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: registered dietitian

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 25, 2013
• Study Start: December 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 17, 2013

Record last verified: 2013-05

Locations

CA (1)