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

Proton Pump Inhibitor Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06268834
• Other study ID #: ZonulinPPI
• Status: Completed
• Phase: N/A
• Start date: October 4, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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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Related Conditions & MeSH terms

• Proton Pump Inhibitor Adverse Reaction

Intervention

Diagnostic Test:
• Blood for zonulin level was drawn from the group.
Serum zonulin levels were determined by taking 5 cc blood from the antebrachial veins of the patients.

Locations

Country	Name	City	State
Turkey	Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

El Asmar R, Panigrahi P, Bamford P, Berti I, Not T, Coppa GV, Catassi C, Fasano A. Host-dependent zonulin secretion causes the impairment of the small intestine barrier function after bacterial exposure. Gastroenterology. 2002 Nov;123(5):1607-15. doi: 10.1053/gast.2002.36578. Erratum In: Gastroenterology 2003 Jan;124(1):275. El Asmar Rahzi [corrected to El Asmar Ramzi]. — View Citation

Fasano A, Shea-Donohue T. Mechanisms of disease: the role of intestinal barrier function in the pathogenesis of gastrointestinal autoimmune diseases. Nat Clin Pract Gastroenterol Hepatol. 2005 Sep;2(9):416-22. doi: 10.1038/ncpgasthep0259. — View Citation

Haastrup PF, Thompson W, Sondergaard J, Jarbol DE. Side Effects of Long-Term Proton Pump Inhibitor Use: A Review. Basic Clin Pharmacol Toxicol. 2018 Aug;123(2):114-121. doi: 10.1111/bcpt.13023. Epub 2018 May 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Zonulin levels in long-term proton pump inhibitor users	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 saklanmistir. Serum örneklerindeki Zonulin seviyeleri Shanghai Crystal Day Biotech Co, Ltd, Shanghai, Çin'den ticari BT-LAB Human Zonulin ELISA kitleri (Kat. No. E1117Hu) kullanilarak ölçülmüstür. 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.	Blood was drawn and collected during the examination and studied collectively after 3 months