Clinical trial NCT05915767: Therapeutic Effect of Olive Leaf Tea on 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
Overall status: COMPLETED
Phase: NA
Conditions: Small Intestinal Bacterial Overgrowth
Gastrointestinal Disorder, Functional
Keywords: Olive leaf tea
Olive leaf
Body composition
Gastrointestinal symptoms
Lead sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Change in Gastrointestinal mean symptomatic score at week 8.
timeFrame: Change from baseline mean symptomatic score at 2 months
measure: Normalization of methane and hydrogen levels in breath test
timeFrame: Change from baseline H2 and CH4 levels at 2 months
Secondary outcomes:
measure: Weight change in kilograms
timeFrame: Change from baseline weight at 2 months
measure: Change in Body fat mass in kilograms
timeFrame: Change from baseline fat mass at 2 months
measure: Change in BMI in kg/m^2
timeFrame: Change from baseline BMI at 2 months
measure: Change in basal metabolic rate (BMR) in kcal
timeFrame: Change from baseline BMR at 2 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: UVAS
state: Punjab
Study officials:
affiliation: University of Veterinary and animal Sciences, Lahore, Punjab, Pakistan.
name: Sanaullah Iqbal, PhD
role: PRINCIPAL_INVESTIGATOR
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