Assessment of Therapeutic Effect of Olive (Olea Europaea L.) Leaf Tea on Gastrointestinal Symptoms and Body Composition in Adults With Small Intestinal Bacterial Overgrowth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Normalization of methane and hydrogen levels in breath test
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •positive hydrogen or methane breath test
排除标准
- •Hospitalized
- •Coronary obstructive pulmonary disease (COPD)
- •Diabetes mellitus
- •history of GI surgeries except cholecystectomy
- •history of GI surgeries except hysterectomy and appendectomy.
结局指标
主要结局
Normalization of methane and hydrogen levels in breath test
时间窗: 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 in Gastrointestinal mean symptomatic score at week 8.
时间窗: 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.
次要结局
- Change in Body fat mass in kilograms(Change from baseline fat mass at 2 months)
- Weight change in kilograms(Change from baseline weight at 2 months)
- Change in BMI in kg/m^2(Change from baseline BMI at 2 months)
- Change in basal metabolic rate (BMR) in kcal(Change from baseline BMR at 2 months)
研究者
Sanaullah Iqbal
Professor
University of Veterinary and Animal Sciences, Lahore - Pakistan