Therapeutic Effect of Olive Leaf Tea on SIBO

Study Overview
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Brief Summary
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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
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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

Official Title
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Assessment of Therapeutic Effect of Olive (Olea Europaea L.) Leaf Tea on Gastrointestinal Symptoms and Body Composition in Adults With Small Intestinal Bacterial Overgrowth

Conditions
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Small Intestinal Bacterial Overgrowth, Gastrointestinal Disorder, Functional

Intervention / Treatment
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* Dietary Supplement: Olive leaf tea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: positive hydrogen or methane breath test Exclusion Criteria: Hospitalized Stroke Coronary obstructive pulmonary disease (COPD) Cancer Diabetes mellitus history of GI surgeries except cholecystectomy history of GI surgeries except hysterectomy and appendectomy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: olive leaf tea<br>SIBO diagnosed individuals in this group will receive olive leaf tea orally, twice a day after meals for 8 weeks. | Dietary Supplement: Olive leaf tea<br>* 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.<br>|
| No Intervention: Control group<br>SIBO diagnosed individuals in this group will not receive olive leaf tea or any intervention for 8 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gastrointestinal mean symptomatic score at week 8. | Gastrointestinal signs and symptoms will be assessed by using a 9 symptomatic questionnaire for SIBO. It is a validated questionnaire in which individuals will be asked to rate their GI symptoms according to frequency, intensity and duration on a 3 point Likert scale ranging from 0 (no symptom) to 3 (severe symptom).Individuals with a mean score ≥4 will be considered suspect of SIBO. | Change from baseline mean symptomatic score at 2 months | 
| Normalization of methane and hydrogen levels in breath test | Hydrogen and methane level in Breath test will be measured by QuinTron breath tracker SC analyzer. Individuals having ≥12 ppm rise in H2 and/or a ≥10 ppm rise in CH4 from the baseline reading or from the lowest preceding value will be diagnosed as positive for SIBO. | Change from baseline H2 and CH4 levels at 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change in kilograms | Electronic weighing scale will be used to assess weight change in both groups. | Change from baseline weight at 2 months | 
| Change in Body fat mass in kilograms | The fat analysis will be done by using InBody 270. It will also tell about percentage of fat in different body segments. | Change from baseline fat mass at 2 months | 
| Change in BMI in kg/m^2 | The BMI will be calculated using weight(kg) and height(m^2). | Change from baseline BMI at 2 months | 
| Change in basal metabolic rate (BMR) in kcal | The BMR will be calculated using analyzer InBody 270. | Change from baseline BMR at 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Olive leaf tea, Olive leaf, Body composition, Gastrointestinal symptoms