miRNA in Pediatric Gastritis

NCT07300787 | Not Yet Recruiting DMC

• 1 other identifier: MD 5-10-2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

miRNA-155; miRNA-204; gastritis; H.pylori

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• weight and height will be combined to report BMI in kg/m

  1 month

Study Arms (2)

Gastritis group

ACTIVE COMPARATOR

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

Control healthy group

PLACEBO COMPARATOR

miRNA gene expression

Diagnostic Test: miRNA gene expression

Interventions

miRNA gene expression 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; Gastritis group

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Faculty of Medicine Benha University

Banhā, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40869058 RESULT

MeSH Terms

Conditions

Gastritis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Central Study Contacts

nashwa f mohamed, MD

CONTACT

00201013085679; nashwafarouk16@gmail.com

ola G behairy, MD

CONTACT

OLAPED99@YAHOO.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pediatrics

Model Details: 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).

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 24, 2025
• Study Start: January 20, 2026
• Primary Completion: March 1, 2026
• Study Completion: June 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)