Effect of Probiotics on Functional Constipation in Adults
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Introduction:

      Functional constipation is a symptom-based gastrointestinal disorder without an organic
      origin (eg, bowel obstruction). It has a prevalence of 14% in adults.

      Objective:

      The objective of trial is to evaluate the efficacy and safety of two different probiotic
      blends in adults subjects with functional constipation.

      Methods:

      A double-blind, randomized, placebo-controlled study will be conducted for up to two years to
      evaluate the efficacy of two different probiotic mixtures: (Mixture 1) Lactobacillus
      acidophilus, Bifidobacterium bifidum and Lactobacillus rhamnosus (3 billion CFU); (Mixture 2)
      Lactobacillus acidophilus, Bifidobacterium bifidum, Lactobacillus rhamnosus, Lactobacillus
      paracasei, Bifidobacterium longum, Bifidobacterium lactis, Lactobacillus defensis,
      Bifidobacterium animallis (8 billion CFU).
    

Detailed description: 
      The study involve 150 healthy volunteers with functional constipation.The sample size was
      based on literature reviews of the probiotics' effect comparing the differences between
      means.

      After confirmation of eligibility and obtaining written informed consent, the patients will
      be randomized (stratification for blocks) to recivied the interventions. The patients and the
      phisician will be blinded to the treatment received. The eligible patients will be allocated
      (1:1:1) to treatment with either the probiotics supplements or placebo. Subjects will be
      instructed to ingest one sachet before breakfast, by mixing the powder in water and drinking
      it. The sachets will be stored at room temperature.

      Data handling and record keeping Case report forms will be used to record data for all
      participants, and will be completed by the research doctor, who will also enter the data into
      an electronic database.

      Study schedule and location After inclusion, all further treatments will be managed at the
      primary care center where the subject was recruited. A research doctor and a research
      pharmacist will be responsible for all contacts with patients.

      Local of study development Recruitment of patients to this study will be made by
      collaboration with the Gastroenterolgy Clinic at Avenue Dr Armando Sales de Oliveira 371,
      Trujilo, Sorocaba, State of São Paulo, Brazil from March 2020 to April 2020. Sorocaba is a
      Brazilian municipality in the interior of the state of São Paulo. It is the fourth most
      populous in the interior of São Paulo in the Southeast of the country, and the most populous
      in the southern region of São Paulo, with a population of 671,186 inhabitants, estimated by
      IBGE for July 1, 2018.

      For comparison of three groups, an independent t-test will be applied for continuous
      variables and Mann-Whitney for non-continuous variables. Analysis of adverse events (if any)
      will be performed using Chi-Square test and Fisher's exact test following assumptions of
      randomness, independence and size. Significance differences will be set at p<0.05.
    

Intervention name(s): Placebo; 3 Billion UFC strains of probiotics; 8 Billion UFC strains of probiotics
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Fibers with vitamins and minerals will be administered for 30 days once a day in sachets; Fibers with vitamins and minerals will be administered for 30 days once a day in sachets with 3 billion CFU strains of probiotics; Fibers with vitamins and minerals will be administered for 30 days once a day in sachets with 8 billion CFU strains of probiotics
Other intervention name(s): Group Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventions: in particular, subjects were divided into 3 groups: i) 50 subjects in the group A will receive placebo, ii) 50 subjetcs in the group B will receive mixed L. acidophilus LA 02 ID 1688, B. bifidum BB 01 ID 1722 and L. rhamnosus LR 04 ID 1132 (1 x 10⁹ colony-forming units/d of each strain) and 50 subjects em the group C will receive L. acidophilus LA 02 ID 1688, B. bifidum BB 01 ID 1722, L. rhamnosus LR 04 ID 1132, L. paracasei LPC 00 ID 1076, B. longum BL 03 ID 1152, B. lactis BS 01 ID 1195, L. casei LC 03 ID 1872, B. animalis LMG 10508 (1 x 10⁹ colony-forming units/d of each strain) for 30 days. At the beginning of the interventional study, the healthy status of volunteers will be evaluated by a complete, laboratory and by the clinical evaluation by the doctor using as reference ROMA IV for intestinal constipation. Exclusion criteria will be items of gastrointestinal diseases, pregnant and antibiotic intake.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lactobacillus; Bifidobacterium