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

NCT ID: NCT06268834

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-04

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Proton Pump Inhibitor Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Using PPI

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.

Group Type EXPERIMENTAL

Blood for zonulin level was drawn from the group.

Intervention Type DIAGNOSTIC_TEST

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

Control

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

Group Type EXPERIMENTAL

Blood for zonulin level was drawn from the group.

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Semih Sezer

clinic physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 16265432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12404235 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29658189 (View on PubMed)

Other Identifiers

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ZonulinPPI

Identifier Type: -

Identifier Source: org_study_id

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