Therapeutic Effect of Olive Leaf Tea on SIBO

NCT05915767 | Completed DMC

• 1 other identifier: SIBO
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Small Intestinal Bacterial Overgrowth; Gastrointestinal Disorder, Functional

Keywords

Olive leaf tea; Olive leaf; Body composition; Gastrointestinal symptoms

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from baseline mean symptomatic score at 2 months

• 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.

  Change from baseline H2 and CH4 levels at 2 months

Secondary Outcomes (4)

• Weight change in kilograms

  Change from baseline weight at 2 months

• Change in Body fat mass in kilograms

  Change from baseline fat mass 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

Study Arms (2)

olive leaf tea

EXPERIMENTAL

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

Control group

NO INTERVENTION

SIBO diagnosed individuals in this group will not receive olive leaf tea or any intervention for 8 weeks.

Interventions

Olive leaf tea DIETARY_SUPPLEMENT

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.

olive leaf tea

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• positive hydrogen or methane breath test

You may not qualify if:

• Hospitalized
• Stroke
• Coronary obstructive pulmonary disease (COPD)
• Cancer
• Diabetes mellitus
• history of GI surgeries except cholecystectomy
• history of GI surgeries except hysterectomy and appendectomy.

Sponsors & Collaborators

• University of Veterinary and Animal Sciences, Lahore - Pakistan: lead

Study Sites (1)

UVAS

Lahore, Punjab Province, Pakistan

Location

Related Publications (13)

• Vezza T, Rodriguez-Nogales A, Algieri F, Garrido-Mesa J, Romero M, Sanchez M, Toral M, Martin-Garcia B, Gomez-Caravaca AM, Arraez-Roman D, Segura-Carretero A, Micol V, Garcia F, Utrilla MP, Duarte J, Rodriguez-Cabezas ME, Galvez J. The metabolic and vascular protective effects of olive (Olea europaea L.) leaf extract in diet-induced obesity in mice are related to the amelioration of gut microbiota dysbiosis and to its immunomodulatory properties. Pharmacol Res. 2019 Dec;150:104487. doi: 10.1016/j.phrs.2019.104487. Epub 2019 Oct 11.

  PMID: 31610229 BACKGROUND

• Liu Y, McKeever LC, Malik NS. Assessment of the Antimicrobial Activity of Olive Leaf Extract Against Foodborne Bacterial Pathogens. Front Microbiol. 2017 Feb 2;8:113. doi: 10.3389/fmicb.2017.00113. eCollection 2017.

  PMID: 28210244 BACKGROUND

• El-Sayed NR, Samir R, Jamil M Abdel-Hafez L, Ramadan MA. Olive Leaf Extract Modulates Quorum Sensing Genes and Biofilm Formation in Multi-Drug Resistant Pseudomonas aeruginosa. Antibiotics (Basel). 2020 Aug 19;9(9):526. doi: 10.3390/antibiotics9090526.

  PMID: 32824901 BACKGROUND

• Mujico JR, Baccan GC, Gheorghe A, Diaz LE, Marcos A. Changes in gut microbiota due to supplemented fatty acids in diet-induced obese mice. Br J Nutr. 2013 Aug;110(4):711-20. doi: 10.1017/S0007114512005612. Epub 2013 Jan 10.

  PMID: 23302605 BACKGROUND

• Kocyigit A, Guler EM, Irban A, Kiran B, Atayoglu AT. Assessment of Association Between the Potential Immunomodulatory Activity and Drinking Olive Leaf Tea in the Coronavirus Disease-2019 Pandemic: An Observational Study. J Integr Complement Med. 2022 Dec;28(12):940-947. doi: 10.1089/jicm.2022.0554. Epub 2022 Sep 16.

  PMID: 36112183 BACKGROUND

• Rocchetti G, Luisa Callegari M, Senizza A, Giuberti G, Ruzzolini J, Romani A, Urciuoli S, Nediani C, Lucini L. Oleuropein from olive leaf extracts and extra-virgin olive oil provides distinctive phenolic profiles and modulation of microbiota in the large intestine. Food Chem. 2022 Jun 30;380:132187. doi: 10.1016/j.foodchem.2022.132187. Epub 2022 Jan 21.

  PMID: 35086016 BACKGROUND

• Erdogan A, Rao SS, Gulley D, Jacobs C, Lee YY, Badger C. Small intestinal bacterial overgrowth: duodenal aspiration vs glucose breath test. Neurogastroenterol Motil. 2015 Apr;27(4):481-9. doi: 10.1111/nmo.12516. Epub 2015 Jan 19.

  PMID: 25600077 BACKGROUND

• Onana Ndong P, Boutallaka H, Marine-Barjoan E, Ouizeman D, Mroue R, Anty R, Vanbiervliet G, Piche T. Prevalence of small intestinal bacterial overgrowth in irritable bowel syndrome (IBS): Correlating H2 or CH4 production with severity of IBS. JGH Open. 2023 Apr 3;7(4):311-320. doi: 10.1002/jgh3.12899. eCollection 2023 Apr.

  PMID: 37125253 BACKGROUND

• Ramirez EM, Brenes M, Romero C, Medina E. Olive Leaf Processing for Infusion Purposes. Foods. 2023 Jan 30;12(3):591. doi: 10.3390/foods12030591.

  PMID: 36766119 BACKGROUND

• Sheeza I, Sanaullah Iqbal, Rabbani I, M Asif Ali. 2021. Prevalence of Small Intestinal Bacterial Overgrowth in People with Gastrointestinal Signs and Symptoms Using Glucose Breath Test. Acta Scientific NUTRITIONAL HEALTH (ISSN:2582-1423). 05(12 December 2021).

  BACKGROUND

• Mattioli LB, Frosini M, Amoroso R, Maccallini C, Chiano E, Aldini R, Urso F, Corazza I, Micucci M, Budriesi R. Olea europea L. Leaves and Hibiscus sabdariffa L. Petals Extracts: Herbal Mix from Cardiovascular Network Target to Gut Motility Dysfunction Application. Nutrients. 2022 Jan 21;14(3):463. doi: 10.3390/nu14030463.

  PMID: 35276825 BACKGROUND

• Malfa GA, Di Giacomo C, Cardia L, Sorbara EE, Mannucci C, Calapai G. A standardized extract of Opuntia ficus-indica (L.) Mill and Olea europaea L. improves gastrointestinal discomfort: A double-blinded randomized-controlled study. Phytother Res. 2021 Jul;35(7):3756-3768. doi: 10.1002/ptr.7074. Epub 2021 Mar 16.

  PMID: 33724592 BACKGROUND

• Dekaboruah E, Suryavanshi MV, Chettri D, Verma AK. Human microbiome: an academic update on human body site specific surveillance and its possible role. Arch Microbiol. 2020 Oct;202(8):2147-2167. doi: 10.1007/s00203-020-01931-x. Epub 2020 Jun 10.

  PMID: 32524177 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Sanaullah Iqbal, PhD

  University of Veterinary and animal Sciences, Lahore, Punjab, Pakistan.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be divided into two groups. One group will take olive leaf tea, and the other group will receives no tea.

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 23, 2023
• Study Start: June 1, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 15, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)