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

NCT06268834 | Completed

• 1 other identifier: ZonulinPPI
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Proton Pump Inhibitor Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• 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 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.

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

Study Arms (2)

Using PPI

EXPERIMENTAL

Group receiving a long-term PPI (omeprazole, lansoprazole, pantoprazole, esomeprazole and rabeprazole) every day for at least 6 months or at least twice a week for at least 2 years.

Diagnostic Test: Blood for zonulin level was drawn from the group.

Control

EXPERIMENTAL

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

Diagnostic Test: Blood for zonulin level was drawn from the group.

Interventions

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.

Control; Using PPI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Sites (1)

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 16265432 BACKGROUND

• 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.

  PMID: 12404235 BACKGROUND

• 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.

  PMID: 29658189 BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

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

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: October 4, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)