Therapeutic Effect of Olive Leaf Tea on SIBO (SIBO)

January 11, 2024 updated by: Sanaullah Iqbal, University of Veterinary and Animal Sciences, Lahore - Pakistan

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • UVAS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: olive leaf tea
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
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.
No Intervention: Control group
SIBO diagnosed individuals in this group will not receive olive leaf tea or any intervention for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gastrointestinal mean symptomatic score at week 8.
Time Frame: Change from baseline mean symptomatic score at 2 months
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
Time Frame: Change from baseline H2 and CH4 levels at 2 months
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
Time Frame: Change from baseline weight at 2 months
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
Time Frame: Change from baseline fat mass at 2 months
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
Time Frame: Change from baseline BMI at 2 months
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
Time Frame: Change from baseline BMR at 2 months
The BMR will be calculated using analyzer InBody 270.
Change from baseline BMR at 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Veterinary and Animal Sciences, Lahore - Pakistan

Investigators

  • Principal Investigator: Sanaullah Iqbal, PhD, University of Veterinary and animal Sciences, Lahore, Punjab, Pakistan.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

November 15, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIBO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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