miRNA in Pediatric Gastritis (microRNA)

Role of miRNA-155 and miRNA-204 in Pediatric Gastritis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HELICOBACTER PYLORI INFECTIONS
• Intervention / Treatment: Diagnostic test: miRNA gene expression

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: nashwa f mohamed, MD; Phone Number: 00201013085679; Email: nashwafarouk16@gmail.com
• Study Contact Backup: Name: ola G behairy, MD; Email: OLAPED99@YAHOO.COM

Study Locations

• Egypt
  • Banhā, Egypt
    • Faculty of Medicine Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Diagnostic test: 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
Placebo Comparator: Control healthy group; miRNA gene expression	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
differential expression of mRNA-204 and mRNA-155 in relation to gastritis, and assess their relation with the presence of H. pylori in children	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 Tissue Ruptor. 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.	in 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight and height will be combined to report BMI in kg/m	Body Mass Index (BMI) is a screening tool using your weight and height to estimate body fat, calculated by dividing weight (kg) by height (m²) to categorize enrolled children into underweight, healthy, overweight, or obese, kilogram/meters^2	1 month

Collaborators and Investigators

• Sponsor: Benha University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2026
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: gastritis; H.pylori; miRNA-155; miRNA-204
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis
• Other Study ID Numbers: MD 5-10-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No