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
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
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
NCT ID
NCT05915767
First Posted
May 18, 2023
Last Updated
June 13, 2023
Sponsor
University of Veterinary and Animal Sciences, Lahore - Pakistan
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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