Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05882968 |
| Other study ID # |
H.pylori in CKD patients |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2023 |
| Est. completion date |
September 2025 |
Study information
| Verified date |
May 2023 |
| Source |
Assiut University |
| Contact |
Hanaa Zakaria |
| Phone |
01033721014 |
| Email |
hanaazakaria30[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The study aims to:-
- Investigate the relationship between H. pylori and CKD, in order to determine whether an
association exists between H.pylori and kidneys.
Description:
Helicobacter pylori is a spiral-shaped, gram-negative flagellated bacterium that usually
resides in the gastric mucosa [1]. It affects approximately 50% of the world's population,
even 80% in lower and middle outcome countries [1] [2].
The prevalence according to a study conducted by Ankouane et al. in Yaoundé (Cameroon) is up
to 72.5% in hospital [3]. The main route of transmission is person to person transmission and
often occurs in the first 5 years of life [4].
Helicobacter pylori is the most common human chronic infection, causing gastrointestinal
diseases such as gastric malignancies, gastritis, and ulcerative diseases. H. pylori can also
be involved in other non-gastrointestinal infections such as diabetes and metabolic syndrome,
heart disease, hematologic disorders, cancer, and chronic kidney disease (CKD) as well as
chronic renal failure (CRF) [5].
The risk factors for infection with H. pylori are low socioeconomic level, promiscuity,
family history of H. pylori infection or gastritis, alcohol consumption, smoking [6].
The stomach is reported to be associated with conditions affecting other organs. Such as, an
association between atrophic gastritis (AG) and coronary artery disease has been described,
with AG representing a potential independent risk factor for coronary artery disease [7].
The diagnosis of H. pylori is made by noninvasive methods (the rapid urease test, the breath
test, serology, stool antigen test) or invasive methods biopsy-based tests (culture and
histology) [8]. The gold standard is histology, but current methods have been developed,
using high-definition endoscopy [9].
Chronic kidney disease (CKD) is a growing disease and public health problem worldwide [10].
Gastrointestinal (GI) symptoms are common among subjects with CKD, and their intensity vary
slightly to very severe, altering the quality of life and potentially hindering the
effectiveness of the treatment [11] and also affects their nutrition status leading to the
development of malnutrition, which is a potent predictor of morbidity and mortality [12].
Patients with chronic renal failure (CRF) often have gastrointestinal symptoms caused not
only by H. pylori infection, but also by high urea levels, decline of gastrointestinal
motility, hypergastrinemia and high ammonia levels [10-13].
Moreover, patients with CRF may have higher risks of gastric mucosal damages compared with
individuals with normal renal function because of systemic and/or local chronic circulatory
failure [14].
Epidemiological studies have revealed a link between H. pylori with insulin resistance and
metabolic syndrome , which may increase the risk of CKD. However, up to date there is no
conclusive evidence regarding the association between H. pylori infection and CKD [15].
A previous study reported that individuals infected with H. pylori had a higher risk of
subsequent renal dysfunction than those not infected [12]. Conversely, the H. pylori
infection rate is lower in patients with peptic ulcer disease and concomitant chronic kidney
disease (CKD) than in those without CKD [13]. However, the relationship between H. pylori
infection and/or gastric disorders and CKD has not been elucidated.
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