Effectiveness of Probiotics Stabilized With Cryoprotection Technology in Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Irritable bowel syndrome (IBS) is one of the most common diseases of the digestive tract in
      adults, which pathogenesis is not fully understood. It is assumed that intestinal dysbiosis
      affecting the functioning of the gut-brain axis may be important. Probiotics are live
      microorganisms that, when administered at the right dose, have a positive effect on human
      health. Probiotic mechanism of action is related to the modulation of intestinal microbiota.
      Clinical studies confirm that probiotics administered to patients with IBS have positive
      health effects. Clinical effects depend primarily on the selection of probiotic strains, but
      no less important is their viability and stability in the preparation administered to
      patients. Unfortunately, obtaining stability (a strictly defined number of live probiotic
      strains in the preparation throughout the shelf life of the preparation) is very
      technologically difficult. As shown by the audit of the Polish Supreme Audit Office (NIK),
      almost 90% of probiotics sold on the Polish market do not meet these criteria. There were
      probiotic preparations that by the end of their expiration date had less than 100 live
      bacterial cells from the declared number of about one billion. The only preparations that
      successfully passed NIK inspections turned out to be preparations in which the technology of
      double microcapsulation of bacteria was used. New technologies are constantly being sought
      that increase both the survival of bacterial strains in the preparation and the resistance of
      the strains to hydrochloric acid and bile, which in turn contributes to delivering the right
      dose of probiotics to the target site of activity, i.e. the small and large intestine. Recent
      developed an innovative technology called bacterial cryoprotection, which, compared to
      traditional lyophilization, leads to an increase in the stability of the bacterial cell wall
      membranes and protects them against negative factors both external (high temperature,
      humidity etc.) and internal (gastric acid, bile). Therefore, the purpose of the clinical
      trial is to assess the effectiveness of cryoprotected probiotics in patients with IBS.
    

Detailed description: 
      A 1- to 2-week screening period will be used to establish the presence and persistence of
      trial entry criteria and train patients in the mode of data collection. The screening period
      will also be used to select patients with specified levels of severity of signs and symptoms.
      During screening visit patients will undergo physical examination. Severity of IBS will be
      determined using the Francis, Morris and Whorwell's IBS severity scale (IBS-SSS): Mild <175,
      Moderate 175-300, Severe >300. Number and type of stools will be measured in all patients
      using Bristol stool scale. All eligible patients who sign informed consent form will be
      randomized within 2 weeks to receive either probiotic product or placebo and will complete
      Quality of Life assessment measured using IBS-QOL questionnaire. They will also be instructed
      to restrain from consuming foods and dietary supplements containing probiotics according to
      the clinical study requirements. After receiving probiotic product/placebo, telephone
      interviewers will call patients 3 times per week, and they will collect the following
      information by the phone: type of stools (according to Bristol Stool Score), number of bowel
      movements per day and IBS symptoms measured in 5-point scale (abdominal pain, flatulence,
      feeling of incomplete evacuation). In addition, telephone interviewers will collect
      information regarding adverse effects and using new drugs during the study. Patients will
      report to the doctor 2 times during study every 4 weeks during 8 week lasting intervention to
      receive new dose of probiotic product/placebo and to be assessed by the doctor using IBS-SSS,
      IBS-GIS and IBS-AR questionnaires, They will also complete Quality of Life questionnaire.
    

Intervention name(s): Probiotic; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Multispecies probiotic mixture administered to patients according to the randomization list; Maltodextrin as placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome, probiotics