The Impact of Probiotic Supplementation on Antibiotic Induced Changes in Gastrointestinal Function and/or Faecal Microbiota Composition
Condition: Antibiotic Side Effect
Study type: Interventional

Summary: 
      To investigate whether probiotic supplementation during the consumption of oral antibiotics
      can impact gastrointestinal responses and/or the regrowth of the gut microbiota.
    

Detailed description: 
      The human gut (gastrointestinal tract) is home to more than a trillion mostly "friendly
      bacteria" = the gut microbiota - that support the well-being and health of an individual
      through a variety of mechanisms. Antibiotic treatment impacts on the microbiota and reduces
      the overall numbers and diversity which causes metabolic shifts and increases susceptibility
      to colonization by potentially pathogenic and/or resistant bacteria and thereby increases the
      risk of bacterial antibiotic resistance. This trial aims to investigate whether probiotic
      supplementation during the consumption of oral antibiotics can impact the gastrointestinal
      responses and/or the composition/functionality of the regrowth of the gut microbiota.

      The trial will be a double blinded, placebo-controlled study consisting of 50 participants
      (25 per group), aged 18-65, to be enrolled after being prescribed a 5 to 10-day course of
      antibiotics. The study will be randomized through an independent statistician.

      The study will involve three site visits, the first visit occurs at enrolment when the
      participant is randomised and measures of height, body weight and blood pressure are taken.
      The participants will also answer a quality of life questionnaire at visit 1 and will receive
      the study intervention. A stool sample will be collected at this visit (if possible) and the
      participant will be given two more stool sample collection kits, a gastrointestinal tract
      symptom record sheet too b completed daily throughout the study and a bowel habit diary to be
      completed per defecation..

      The second visit will take place the day after the completion of the prescribed antibiotic
      course and at this visit participants will return a stool sample collected at home the
      previous day, and asked to complete another quality of life questionnaire. The final visit
      will take place at around day 30, when again they will return a stool sample collected within
      48 hours of the visit, return all gastrointestinal symptom record sheets and bowel habit
      diaries as well as returning any unused intervention (for compliance monitoring). Scientists
      will use the information and samples collected to determine if there was any benefit to
      taking the probiotic supplement.

      It is considered that the daily intake of the probiotics will improve general wellbeing and
      mental health. Due to the chance that the participant may receive the placebo, it is
      perceived that these benefits will be confined to the participants who are randomly assigned
      the intervention. Participation in the study will bring more information and will improve our
      understanding of the benefits of daily probiotic supplementation.

      There have been no adverse reactions associated with the regular consumption of this
      probiotic product but participants may experience mild side effects such as a change in bowel
      habit and/ or increased flatulence (intestinal gas) during the first few days of taking the
      supplement.
    

Intervention name(s): LAB4 + Saccharomyces boulardii; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care