Probiotics and Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      This clinical trial was conducted on 90 IBS patients, who fulfill ROME IV criteria and the
      IBS diagnostic questionnaire (Arabic version licensed by Rome Foundation) in Egyptair
      hospital outpatient clinic, Cairo, Egypt between May and December 2019. Data of the patient,
      with suspected IBS during the study period, were reviewed and the patients who fulfilled the
      inclusion criteria were enrolled into this study. A written consent was obtained from all
      included patients. The patients who agreed to participate were then randomly assigned into
      two equal groups and were followed up after 4 weeks from the first visit.
    

Detailed description: 
      The study includes 90 patients assigned into2 equal groups the first was prescribed
      probiotics (10 billion colony of lactobacillus delbruekii and lactobacillus fermentum) and
      itopride hcl 50mg three times daily, while the second group receivedonly itopridehcl 50mg by
      the same dose for four weeks.All patients fulfill ROME IV criteria and the IBS diagnostic
      questionnaire (Arabic version licensed by Rome Foundation). Data of the patient, with
      suspected IBS during the study period, were reviewed and the patients who fulfilled the
      inclusion criteria were enrolled into this study. A written consent was obtained from all
      included patients. The patients who agreed to participate were then randomly assigned into
      two equal groups and were followed up after 4 weeks from the first visit.

      Any patient with red flags (e.g. weight or appetite loss, iron deficiency anemia, fever or
      rectal bleeding), Known inflammatory bowel disease or celiac disease patients, patients above
      50 years of age and immuno-compromised patients were excluded from the study.

      The included patients aged from 18 to 50 years fulfilling Rome IV criteria for diagnosis of
      IBS:Recurrent abdominal pain (on average, at least 1 day/week in the last 3 months)
      associated with two or more of the following: (Related to defecation, Associated with a
      change in frequency of stool, Associated with a change in form of stool).Patients should
      fulfill Rome Foundation IBS-Diagnostic Questionnaire.

      All patients were subjected to initial evaluation byfull history taking, questionnaires for
      (IBS diagnostic questionnaire, IBS-SSSand QOL -IBS survey), clinical examination,
      investigations (including CBC, ESR, CRP, random sugar, HbA1c, thyroid profile and stool
      analysis) and radiological assessment bypelvi-abdominal ultrasound to exclude any organic
      cause..Group one(45 patients) was prescribed probiotic (lactobacillus delbruekii and l.
      fermentum) 10billion colony forming units and itopride 50mg three times daily for four weeks
      while group two was prescribed only itopride 50mg three times daily for four weeks.Then
      reassessment of the questionnaires was done after 4 weeks of treatment for comparison
    

Intervention name(s): lactobacillus delbruekii
Intervention type(s): Drug
Intervention description(s): Comarsion between probiotics and one of the most widely used symptomatc treatment for IBS itopride hcl
Other intervention name(s): and lactobacillus fermentum); and itopride hcl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intestinal microbiota,; probiotics,; quality of life,