Small Intestinal Bacterial OvergrowthSIBONCT05915767

Therapeutic Effect of Olive Leaf Tea on SIBO

A study testing Olive leaf tea in people with Small Intestinal Bacterial Overgrowth and Gastrointestinal Disorder, Functional, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Small Intestinal Bacterial Overgrowth, Gastrointestinal Disorder, Functional
What is being tested?: Olive leaf tea
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 sitePakistan
Study dates: 1 Jun 2023to 15 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

positive hydrogen or methane breath test

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

UVAS
Lahore, Punjab Province

Other trials in Pakistan

About this study

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

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

Read the 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

Conditions: Small Intestinal Bacterial Overgrowth, Gastrointestinal Disorder, Functional
Being tested: Olive leaf tea
Keywords: Olive leaf tea, Olive leaf, Body composition, Gastrointestinal symptoms
Medical subject headings: Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Olive leaf teaDietary 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.

Study groups in NCT05915767
Study group	Role	What they receive
olive leaf tea	Experimental	SIBO diagnosed individuals in this group will receive olive leaf tea orally, twice a day after meals for 8 weeks. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Change from baseline H2 and CH4 levels at 2 months

Secondary outcomes (4)

Weight change in kilograms
Electronic weighing scale will be used to assess weight change in both groups.
Measured: Change from baseline weight at 2 months
Change in Body fat mass in kilograms
The fat analysis will be done by using InBody 270. It will also tell about percentage of fat in different body segments.
Measured: Change from baseline fat mass at 2 months
Change in BMI in kg/m^2
The BMI will be calculated using weight(kg) and height(m^2).
Measured: Change from baseline BMI at 2 months
Change in basal metabolic rate (BMR) in kcal
The BMR will be calculated using analyzer InBody 270.
Measured: Change from baseline BMR at 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202315 Dec 2023

First posted23 Jun 2023
Study start1 Jun 2023
Primary completion15 Nov 2023
Study completion15 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Small Intestinal Bacterial OvergrowthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be divided into two groups. One group will take olive leaf tea, and the other group will receives no tea.
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05915767
Sponsor's protocol ID: SIBO
Acronym: SIBO
Status last verified: Jan 2024
First submitted: 18 May 2023
Last updated: 12 Jan 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31610229
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.
PubMed 28210244
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.
PubMed 32824901
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.
PubMed 23302605
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.
PubMed 36112183
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.
PubMed 35086016
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.
PubMed 25600077
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.
PubMed 37125253
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.
PubMed 36766119
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).
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.
PubMed 35276825
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.
PubMed 33724592
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.
PubMed 32524177

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Small Intestinal Bacterial Overgrowth trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05915767
Acronym / sponsor ID: SIBO / SIBO
Conditions: Small Intestinal Bacterial Overgrowth, Gastrointestinal Disorder, Functional
Keywords: Olive leaf tea, Olive leaf, Body composition, Gastrointestinal symptoms
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of Veterinary and Animal Sciences, Lahore - PakistanUniversity, hospital or other
Study start: 1 Jun 2023 (actual)
Primary completion: 15 Nov 2023 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 23 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Phase 1: Olive leaf tea preparation

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:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants will be divided into two groups. One group will take olive leaf tea, and the other group will receives no tea.

Arm	Type	Receives
olive leaf tea	Experimental	Dietary Supplement: Olive leaf teaSIBO diagnosed individuals in this group will receive olive leaf tea orally, twice a day after meals for 8 weeks.
Control group	No intervention	–SIBO diagnosed individuals in this group will not receive olive leaf tea or any intervention for 8 weeks.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

positive hydrogen or methane breath test

Key exclusion criteria (7 listed)

Hospitalized
Stroke
Coronary obstructive pulmonary disease (COPD)
Cancer
Diabetes mellitus

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Olive leaf teaFresh 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.	Dietary supplement	olive leaf tea

Primary outcome

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.
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.

4 secondary outcomes

Weight change in kilograms
Time frame: Change from baseline weight at 2 months
Change in Body fat mass in kilograms
Time frame: Change from baseline fat mass at 2 months
Change in BMI in kg/m^2
Time frame: Change from baseline BMI at 2 months
Change in basal metabolic rate (BMR) in kcal
Time frame: Change from baseline BMR at 2 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
Background: PubMed 31610229Vezza 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.
Background: PubMed 28210244Liu 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.
Background: PubMed 32824901El-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.
Background: PubMed 23302605Mujico 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.
Background: PubMed 36112183Kocyigit 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.
Background: PubMed 35086016Rocchetti 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.
Background: PubMed 25600077Erdogan 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.
Background: PubMed 37125253Onana 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.
Background: PubMed 36766119Ramirez EM, Brenes M, Romero C, Medina E. Olive Leaf Processing for Infusion Purposes. Foods. 2023 Jan 30;12(3):591. doi: 10.3390/foods12030591.
BackgroundSheeza 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: PubMed 35276825Mattioli 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.
Background: PubMed 33724592Malfa 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.
Individual participant dataSharing planned: No

Related trials for Small Intestinal Bacterial Overgrowth

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sanaullah Iqbal, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Gastrointestinal mean symptomatic score at week 8. (time frame: Change from baseline mean symptomatic score at 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05915767, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.