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Completed

NCT Number: NCT06268834

Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome

Our study aims to investigate the effect of bacterial overgrowth induced by long-term PPI use on zonulin levels.

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Key information

Conditions

Proton Pump Inhibitor Adverse Reaction

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

About this study

The study included a total of 75 participants, with 45 individuals classified as long-term PPI users and 30 as non-PPI users. The PPI user group was defined as those who had been consistently using PPIs (specifically omeprazole, lansoprazole, pantoprazole, esomeprazole, or rabeprazole) on a daily basis for a minimum of 6 months or at least twice a week for a minimum of 2 years. The control group comprised individuals who had never used PPIs. Venous blood samples were taken from all participants to measure serum zonulin levels.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The patient group was patients taking long-term PPIs (omeprazole, lansoprazole, pantoprazole, esomeprazole and rabeprazole) every day for at least 6 months or at least twice a week for at least 2 years.

A control group was formed from individuals who had never used PPI.

Exclusion criteria

Those with inflammatory bowel disease, celiac disease, type 1 diabetes, active gastroenteritis, acute kidney failure, chronic kidney failure, and those who had used antibiotics for any reason in the last 3 months, as well as those receiving probiotic drug support, were not included in the study

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Treatment and study plan

Blood for zonulin level was drawn from the group.

Diagnostic Test

Serum zonulin levels were determined by taking 5 cc blood from the antebrachial veins of the patients.

Primary outcomes

  1. Zonulin levels in long-term proton pump inhibitor users

    Time frame: Blood was drawn and collected during the examination and studied collectively after 3 months

    Approximately 5 cc of blood was drawn from the antebrachial veins of the patients to determine serum zonulin levels. Serum örnekleri -80 santigrat derecede 3 ay süreyle saklanmıştır. Serum örneklerindeki Zonulin seviyeleri Shanghai Crystal Day Biotech Co, Ltd, Shanghai, Çin'den ticari BT-LAB Human Zonulin ELISA kitleri (Kat. No. E1117Hu) kullanılarak ölçülmüştür. The test range of the kit was 2-600 ng/ml. The sensitivity of the test was 1.09 ng/ml. A serum zonulin level above 12 ng/ml was considered positive.

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Official study title

Is Long-Term Proton Pump Inhibitor Use a Cause of Leaky Gut Syndrome: A Cross-Sectional Case-Control Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2024
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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