Therapeutic Effect of Olive Leaf Tea on SIBO
Condition: Small Intestinal Bacterial Overgrowth; Gastrointestinal Disorder, Functional
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      The goal of this study is to learn about the effect of olive leaf tea (OLT) in patients with
      small intestinal bacterial overgrowth aging from 18 to 60 years old. This study aims to
      answer the following questions:

        -  Will OLT consumption help decrease severity of gastrointestinal signs and symptoms

        -  Will OLT help normalize the intestinal methane and hydrogen gases levels measured by
           glucose breath test

        -  Does olive leaf tea have an effect on body composition parameters including weight,
           muscle mass and fat mass Participants with complain of gastrointestinal symptoms like
           abdominal gas, constipation, diarrhea etc. will undergo glucose breath test(GBT).
           Participants with diagnosed SIBO by GBT will randomly assigned to two groups. Group A
           will take the olive leaf tea(1.8g leave powder /tea bag) twice/day after meals for the
           duration of 2 months. Group B (control group) will not take olive leaf tea. For both
           groups Symptomatic questionnaire, Glucose breath test, Body composition by InBody
           analyzer 270 and 24-hour dietary recall will be taken. Researcher will compare readings
           of group A and Group B taken at Baseline and after 2 months of intervention to assess
           the effect of Olive leaf tea
    

Detailed description: 
      Small intestinal bacterial overgrowth (SIBO), characterized by an abnormal increase in the
      population of overall or harmful bacteria species in the small intestine, resulting in
      malabsorption, malnutrition, alter body composition and can lead to further complications if
      not addressed timely. Herbal therapy is considered quite effective in treating SIBO. No
      literal data is available concerning therapeutic effect of olive leaf tea on SIBO patients.
      Olive leaves consist of high concentration of phenolic compounds and essential fatty acids
      that assist in restoring altered gut microbiota and in weight management, also possess
      significant antimicrobial effect against opportunistic intestinal bacteria. Objective of this
      study is to evaluate the antimicrobial potential of olive leaf infusion on intestinal
      microbiota analyzed by hydrogen and methane breath test and its effect on body composition
      parameters in SIBO individuals. This study will also observe the effect of OLT on
      gastrointestinal signs and symptoms. This study comprises of 3 phases:

      Phase 1: Olive leaf tea preparation

      Phase 2: Participants recruitment Study participants will be recruited via circulating SIBO
      screening questionnaires throughout the university. Individuals with mean symptomatic score
      (≥4) and fulfilling the inclusion criteria will be examined using a confirmatory test known
      as the hydrogen/methane breath test (BT). 50g glucose solubilized in 250 mL water given to
      participants orally. Breath samples will be taken every 15 minutes for 2 hours. After written
      and oral consent, 50 participants with positive BT results will be included in the study.
      Experimental design: SIBO-diagnosed individuals will be randomly assigned to two groups
      (treatment and control) with 25 participants in each group. The treatment group will take tea
      twice a day after meals for 2 months. Participants will be requested to record the following
      information daily: consumption of OLT and any side effects if experienced the control group
      will not receive tea or any other intervention.

      Phase 3: Assessment tests: GI symptoms, Hydrogen and methane breath test, 24-hour dietary
      intake, and body composition analysis will be done before and after the intervention.

      Statistical analysis:

      Microsoft excel will be used for data coding. Descriptive analysis will be carried out by
      using SPSS version 23 (SPSS for Windows version 23; SPSS Inc., Chicago, IL, USA). Independent
      sample t-test and Pearson chi-square test will be used to compare control and treatment
      groups. Paired sample t-test will be performed to measure within-group differences from the
      baseline. A chi-square test will be applied to develop a correlation between age, gender, and
      BMI with SIBO. P<0.05 was considered significant for all analysis
    

Intervention name(s): Olive leaf tea
Intervention type(s): Dietary Supplement
Intervention description(s): Fresh olive leaves will be procured from Chakwal, Pakistan. The leaves will be rinsed to remove dust and debris and dried at 40℃ in the oven. The leaves will be ground into powder form and then incorporated in tea bags containing 1.8 g leave powder/tea bag. Participants in treatment group will be instructed to dip the tea bag in 200-250 ml boiling water for 3-5 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be divided into two groups. One group will take olive leaf tea, and the other group will receives no tea.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Olive leaf tea; Olive leaf; Body composition; Gastrointestinal symptoms