miRNA in Pediatric Gastritis

NCT ID: NCT07300787

Last Updated: 2025-12-24

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-20

Study Completion Date

2026-06-01

Brief Summary

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The goal of this clinical trial is to assess the differential expression of miR-155 and miRNA-204 in relation to gastritis, and assess their relation with the presence of H. pylori in children.

Detailed Description

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patients will be subjected to full history taking including age, sex, residence, present illness; onset, course and duration, abdominal pain, other associated symptoms and family history. Assessment of anthropometric measurement Patients' height and weight for age and BMI percentiles were checked according to Egyptian growth curves (9).

Abdominal Ultrasonography upper GITendoscopy mi RNAGene expression was done by quantitative reverse transcription-polymerase chain reaction (qRT-PCR).

Conditions

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HELICOBACTER PYLORI INFECTIONS

Keywords

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miRNA-155 miRNA-204 gastritis H.pylori

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Gastric and duodenal biopsies specimens will obtained from patients undergoing upper gastrointestinal endoscopy for the investigation of recurrent abdominal pain. None of the patients had received any medication which may have affected gastric acidity before endoscopy. Upper GIT endoscopy was performed H.pylori was identified by Giemsa staining. Grossendoscopic findings such as peptic ulcer and erosion in the distal esophagus and stomach were regarded as pathological.Gene expression was done by quantitative reverse transcription-polymerase chain reaction (qRT-PCR).
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Gastritis group

All included patients were subjected to full history taking including age, sex, residence, present illness; onset, course and duration, abdominal pain, other associated symptoms and family history. Assessment of anthropometric measurement Patients' height and weight for age and BMI percentiles were checked according to Egyptian growth curves .

Abdominal Ultrasonography upper GIT ENDOSCOPY miRNA gene expression

Group Type ACTIVE_COMPARATOR

miRNA gene expression

Intervention Type DIAGNOSTIC_TEST

Gene expression was done by quantitative reverse transcription-polymerase chain reaction (qRT-PCR).

Paraffin-embedded biopsies were sectioned into 10-μm-thick slices, two of which were deposited into 1.5-ml microcentrifuge tubes and dewaxed via immersion in xylene at 50 °C, followed by absolute and 96% ethanol.

Extraction of total RNA (including miRNA) was performed using the Qiagen RNeasyPlus Universal Mini Kit (Qiagen, Hilden, Germany) according to manufacturer's protocol. Briefly, the samples were homogenized in QIAzol Lysis Reagent using TissueRuptor. RNA was further precipitated with chloroform, mixed with 1.5 volumes of 100% of Ethanol and following precipitation and washing steps eluted in RNase-free water. The concentration of extracted RNA was assessed using UV-spectrophotometry. MiRNA expression was quantitatively evaluated using either the TaqMan miRNA assay (Applied Biosystems, CA, USA) or SYBR Green (RNU6b) method. Approximately 20 ng of total RNA were reverse tran

Control healthy group

miRNA gene expression

Group Type PLACEBO_COMPARATOR

miRNA gene expression

Intervention Type DIAGNOSTIC_TEST

Gene expression was done by quantitative reverse transcription-polymerase chain reaction (qRT-PCR).

Paraffin-embedded biopsies were sectioned into 10-μm-thick slices, two of which were deposited into 1.5-ml microcentrifuge tubes and dewaxed via immersion in xylene at 50 °C, followed by absolute and 96% ethanol.

Extraction of total RNA (including miRNA) was performed using the Qiagen RNeasyPlus Universal Mini Kit (Qiagen, Hilden, Germany) according to manufacturer's protocol. Briefly, the samples were homogenized in QIAzol Lysis Reagent using TissueRuptor. RNA was further precipitated with chloroform, mixed with 1.5 volumes of 100% of Ethanol and following precipitation and washing steps eluted in RNase-free water. The concentration of extracted RNA was assessed using UV-spectrophotometry. MiRNA expression was quantitatively evaluated using either the TaqMan miRNA assay (Applied Biosystems, CA, USA) or SYBR Green (RNU6b) method. Approximately 20 ng of total RNA were reverse tran

Interventions

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miRNA gene expression

Gene expression was done by quantitative reverse transcription-polymerase chain reaction (qRT-PCR).

Paraffin-embedded biopsies were sectioned into 10-μm-thick slices, two of which were deposited into 1.5-ml microcentrifuge tubes and dewaxed via immersion in xylene at 50 °C, followed by absolute and 96% ethanol.

Extraction of total RNA (including miRNA) was performed using the Qiagen RNeasyPlus Universal Mini Kit (Qiagen, Hilden, Germany) according to manufacturer's protocol. Briefly, the samples were homogenized in QIAzol Lysis Reagent using TissueRuptor. RNA was further precipitated with chloroform, mixed with 1.5 volumes of 100% of Ethanol and following precipitation and washing steps eluted in RNase-free water. The concentration of extracted RNA was assessed using UV-spectrophotometry. MiRNA expression was quantitatively evaluated using either the TaqMan miRNA assay (Applied Biosystems, CA, USA) or SYBR Green (RNU6b) method. Approximately 20 ng of total RNA were reverse tran

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

recurrent abdominal pain warranting upper gastrointestinal endoscopy or gastroscopy including

* peptic-like dyspepsia (identified by two or more symptoms such as periodic pain, pain relief with food or antacid, pre-meal or hunger-induced pain, nausea/vomiting, and nighttime pain),
* dysmotility-like dyspepsia (characterized by abdominal distension, anorexia, weight loss, pain worsening with food/milk, and belching),
* and reflux-like dyspepsia (manifesting as heartburn, chest pain

Exclusion Criteria

-patients with gastrointestinal disorders explaining abdominal pain (e.g., inflammatory bowel disease, celiac disease, functional abdominal pain)

, -patients on proton pump inhibitors, as well as those with significant medical comorbidities.


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Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Nashwa farouk Mohamed

lecturer of pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine Benha University

Banhā, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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nashwa f mohamed, MD

Role: CONTACT

Phone: 00201013085679

Email: [email protected]

ola G behairy, MD

Role: CONTACT

Email: [email protected]

References

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Bordin DS, Livzan MA, Mozgovoi SI, Gaus OV. Autoimmune Gastritis and Helicobacter pylori Infection: Molecular Mechanisms of Relationship. Int J Mol Sci. 2025 Aug 11;26(16):7737. doi: 10.3390/ijms26167737.

Reference Type RESULT
PMID: 40869058 (View on PubMed)

Other Identifiers

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MD 5-10-2023

Identifier Type: -

Identifier Source: org_study_id