Efficacy of Bifidobacterium Lactis CCT 7858 in Adults Using Antibiotics
Condition: Surgery; Infection
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effectiveness of the probiotic Bifidobacterium lactis CCT 7858 in preventing
      and / or improving gastrointestinal symptoms in adults using antibiotics. For this, a
      randomized, double-blind, placebo-controlled clinical trial will be carried out. The sample
      will be composed of adults who will be recruited in a hospital, who have been hospitalized
      and receive a prescription for antibiotics. The individuals will be separated into two
      groups: intervention and placebo. 104 patients will be included, 52 for each group. Inclusion
      criteria:

      adults of both sexes and aged between 18 and 65 years, who have been recruited within 24
      hours after starting antibiotic treatment, the prescribed treatment should be with
      antibiotics for a minimum of 9 days and a maximum of 14 days. The informed consent must be
      signed before starting the study.
    

Detailed description: 
      Two groups (placebo and intervention) will receive supplementation, the Placebo group will
      receive maltodextrin and Intervention group will receive probiotic B. lactis, that should be
      consumed for a period of 10 to 14 days depending on the duration of administration of the
      antibiotic (should be consumed until 7 day after the last antibiotic).

      As a way of ensuring an equal distribution of the number of participants in the study groups
      and ensuring that the groups are similar, a randomization by blocks will be carried out and
      stratified by sex and age. The program that will be used to generate random numbers is the
      Research Randomizer Form v4.0. The packaging of both supplements will be identical except for
      the color, which will distinguish maltodextrin from probiotic.

      Supplements will be delivered by a research collaborator as a way to guarantee blinding.

      The probiotic to be supplied will be Bifidobacterium lactis CCT 7858 (GABBIA® Biotechnology
      and Development, Santa Catarina, Brazil). The probiotic will be offered in capsule and in the
      concentration of 9x10 10 UFC.

      The groups will be evaluated in two moments: baseline and final.

      The evaluation of the individuals will be performed through the collection of the following
      data: necessity and duration of antibiotic therapy (type of antibiotic) used while
      participating in the study.

      Blood pressure will also be assessed.

      Body weight will be measured. The body mass index will be calculated

      In order to verify the tolerance and effectiveness of the supplements, questions regarding
      the frequency and consistency of feces will be asked, evaluated using the Bristol scale (1:
      separate pieces, 2: segmented sausage shape, 3: cracked sausage shape, 4: smooth and soft
      sausage shape, 5: soft pieces, 6: aerated pieces, 7: watery) and gastrointestinal symptoms
      (excess flatulence in the rectum, abdominal distention, borborisms, abdominal pain and the
      occurrence of vomiting or nausea), will be assessed daily throughout the study period using a
      five-point scale (0: none, 1: weak, 2: moderate, 3: strong, 4: very strong).

      In addition, the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire will be used to
      assess symptomatic evolution.

      Before starting the intervention, each participant will record the frequency of defecation,
      characteristics and feeling of defecation (as an initial assessment) and daily after the
      start of the intervention.

      They will fill out a questionnaire about bowel function weekly.

      Changes in quality of life during the study will be measured by the SF-36 questionnaire,
      which consists of 36 items encompassed in 8 scales or components: functional capacity,
      physical aspects, pain, general health, vitality, social aspects, emotional aspects, mental
      health and another question of comparative evaluation between the current health conditions
      and that of a year ago.

      The data will be organized and recorded in a database in the Microsoft Office Excel 2007®
      program with double entry. The statistical analysis will be performed in the Statistical
      statistical program Package for the Social Sciences (SPSS) version 24.0 for Windows.

      Quantitative variables will be described and presented in mean and standard deviation from
      the mean if the distribution is symmetrical or in median and interquartile range if it is
      asymmetric. Nominal variables will be described in frequency categories as of the appearance
      in the described groups. To assess the distribution of data, the Shapiro-Wilk normality test
      will be applied. If the data is asymmetric, it will undergo logarithmic normalization or the
      non-parametric test will be used.

      The intragroup changes will be analyzed by the difference (Basal and End) between the
      variables, using the paired Student t test or Wilcoxon.

      When including 60% of patients, the data will be evaluated by an independent researcher to
      check whether the difference estimates are true. If necessary, the sample calculation will be
      reassessed

      The assessment of treatment adherence will be measured by self-report on the daily assessment
      and telephone interviews, and at the end of the study you will be asked to deliver the
      supplement package.
    

Intervention name(s): Bifidobacterium Lactis CCT7858; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic B Lactis; Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: probiotic; antibiotic; B lactis