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Not yet recruitingNCT07300787microRNAUpdated Dec 24, 2025

miRNA in Pediatric Gastritis

An interventional study of miRNA gene expression in HELICOBACTER PYLORI INFECTIONS, sponsored by Benha University. Not yet recruiting at 1 site in Egypt. Open to participants aged 1 Year to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Benha University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
1 Year to 18 Years
Sex
All
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Study 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.

Read the 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).

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Conditions studied

  • HELICOBACTER PYLORI INFECTIONS

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Keywords

  • miRNA-155
  • miRNA-204
  • gastritis
  • H.pylori
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In context

Gastritis

196 studies on the registry are indexed under Gastritis; 42 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 113 interventional studies indexed under Gastritis.

Browse Gastritis studies →

Lead sponsor

Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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:

-

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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    Control healthy group

    miRNA gene expression

    Diagnostic Test: miRNA gene expression

Interventions

  • Diagnostic testmiRNA 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

06

What researchers measure

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.

    Time frame: in 1 month

Other outcomes

  1. 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

    Time frame: 1 month

07

Study locations

1 site
  • Faculty of Medicine Benha University
    Banhā, Egypt
08

References and documents

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. PubMed 40869058 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07300787
Lead sponsor
Benha University
Responsible party
Nashwa farouk Mohamed (lecturer of pediatrics, Benha University) — Principal investigator
First posted
Dec 24, 2025
Start date
Jan 20, 2026 (estimated)
Primary completion
Mar 1, 2026 (estimated)
Completion
Jun 1, 2026 (estimated)
Last update
Dec 24, 2025

Study contacts

nashwa f mohamed, MD
Contact
nashwafarouk16@gmail.com
00201013085679
ola G behairy, MD
Contact
OLAPED99@YAHOO.COM

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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