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Therapeutic Effect of Olive Leaf Tea on SIBO (SIBO)

Primary Purpose

Small Intestinal Bacterial Overgrowth, Gastrointestinal Disorder, Functional

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Olive leaf tea
Sponsored by
University of Veterinary and Animal Sciences, Lahore - Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Intestinal Bacterial Overgrowth focused on measuring Olive leaf tea, Olive leaf, Body composition, Gastrointestinal symptoms

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    olive leaf tea

    Control group

    Arm Description

    SIBO diagnosed individuals in this group will receive olive leaf tea orally, twice a day after meals for 8 weeks.

    SIBO diagnosed individuals in this group will not receive olive leaf tea or any intervention for 8 weeks.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Weight change in kilograms
    Electronic weighing scale will be used to assess weight change in both groups.
    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 in BMI in kg/m^2
    The BMI will be calculated using weight(kg) and height(m^2).
    Change in basal metabolic rate (BMR) in kcal
    The BMR will be calculated using analyzer InBody 270.

    Full Information

    First Posted
    May 18, 2023
    Last Updated
    June 13, 2023
    Sponsor
    University of Veterinary and Animal Sciences, Lahore - Pakistan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05915767
    Brief Title
    Therapeutic Effect of Olive Leaf Tea on SIBO
    Acronym
    SIBO
    Official Title
    Assessment of Therapeutic Effect of Olive (Olea Europaea L.) Leaf Tea on Gastrointestinal Symptoms and Body Composition in Adults With Small Intestinal Bacterial Overgrowth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 20, 2023 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Veterinary and Animal Sciences, Lahore - Pakistan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Small Intestinal Bacterial Overgrowth, Gastrointestinal Disorder, Functional
    Keywords
    Olive leaf tea, Olive leaf, Body composition, Gastrointestinal symptoms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    olive leaf tea
    Arm Type
    Experimental
    Arm Description
    SIBO diagnosed individuals in this group will receive olive leaf tea orally, twice a day after meals for 8 weeks.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    SIBO diagnosed individuals in this group will not receive olive leaf tea or any intervention for 8 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Olive leaf tea
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Gastrointestinal mean symptomatic score at week 8.
    Description
    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.
    Time Frame
    Change from baseline mean symptomatic score at 2 months
    Title
    Normalization of methane and hydrogen levels in breath test
    Description
    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.
    Time Frame
    Change from baseline H2 and CH4 levels at 2 months
    Secondary Outcome Measure Information:
    Title
    Weight change in kilograms
    Description
    Electronic weighing scale will be used to assess weight change in both groups.
    Time Frame
    Change from baseline weight at 2 months
    Title
    Change in Body fat mass in kilograms
    Description
    The fat analysis will be done by using InBody 270. It will also tell about percentage of fat in different body segments.
    Time Frame
    Change from baseline fat mass at 2 months
    Title
    Change in BMI in kg/m^2
    Description
    The BMI will be calculated using weight(kg) and height(m^2).
    Time Frame
    Change from baseline BMI at 2 months
    Title
    Change in basal metabolic rate (BMR) in kcal
    Description
    The BMR will be calculated using analyzer InBody 270.
    Time Frame
    Change from baseline BMR at 2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ayesha Zafar, MPhil
    Phone
    +923207981670
    Email
    ashazafar123@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sanaullah Iqbal, PhD
    Phone
    +923338981489
    Email
    sanaullah.iqbal@uvas.edu.pk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sanaullah Iqbal, PhD
    Organizational Affiliation
    University of Veterinary and animal Sciences, Lahore, Punjab, Pakistan.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Therapeutic Effect of Olive Leaf Tea on SIBO

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