CompletedNot Applicable

Therapeutic Effect of Olive Leaf Tea on SIBO

Pakistan50 participantsStarted 2023-06-01

Plain-language 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

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Gastrointestinal mean symptomatic score at week 8.

Timeframe: Change from baseline mean symptomatic score at 2 months

Normalization of methane and hydrogen levels in breath test

Timeframe: Change from baseline H2 and CH4 levels at 2 months

Trial details

NCT IDNCT05915767

SponsorUniversity of Veterinary and Animal Sciences, Lahore - Pakistan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-15

View on ClinicalTrials.gov More Small Intestinal Bacterial Overgrowth trials