Effect of Acetaminophen Versus Ibuprofen in Treating Recurrent Apthous Ulcers in Pediatric Celiac Disease

NCT06149507 | Unknown Phase 4 DMC

• 1 other identifier: 14422021417131
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Celiac disease (CD) is a chronic autoimmune enteropathy. It results from genetic predisposition and exposure to gluten-containing food. Individuals carrying human leucocytes antigen (HLA) markers DQ2 or DQ8 are genetically predisposed. Gluten is a protein found in wheat, rye, and barley; the main ingredients of bread, pasta, and pastries. Gluten works as a triggering factor for CD, but the interaction between genetic and environmental factors is still not fully understood. Celiac disease can alter the absorption of drugs. Due to its vast surface area compared with the stomach, most drug absorption occurs in the small intestine and in celiac disease; the surface area available for absorption is substantially reduced due to villous atrophy. Patients with celiac disease develop a variety of gastric disorders requiring oral medications, but the impact of damage to intestinal villi and other celiac disease squeal on drug absorption remains poorly understood. A review of the pertinent literature (English-language articles on research in adults published during the period 1970-August 2012) identified several reports of altered drug absorption mechanisms in patients with celiac disease, including accelerated or delayed gastric emptying, increased permeability of jejunal mucosa, changes in intraluminal pH, decreased intestinal surface area, and reduced intestinal cytochrome P-450 enzymes. A small number of published studies suggest that celiac disease may be associated with altered drug absorption, resulting in higher serum concentrations of propranolol, lower peak concentrations of acetaminophen and practolol, higher dosing requirements with levothyroxine, impaired or delayed absorption of certain antibiotics, and other pharmacokinetic effects with a potential impact on medication efficacy and toxicity. However, these studies involved very small patient samples and were poorly controlled, with some yielding contradictory results. More and larger pharmacokinetic studies in patients with celiac disease-especially studies of drugs that are dosed empirically or are not amenable to dosage adjustment according to vital signs or laboratory values-are needed.

Conditions

Celiac Disease in Children

Outcome Measures

Primary Outcomes (1)

• change in pain intensity

  faces pain scale score (from no pain \[score 0\] to maximum pain intensity \[score 10\] )

  6 month

Secondary Outcomes (4)

• presence of recurrent apthous ulcer

  baseline, before intervention

• Occurrence of Dental enamel defects (DED)

  baseline, before intervention

• Dental caries experience

  baseline, before intervention

• Delayed dental eruption

  baseline, before intervention

Study Arms (2)

Acetaminophen

EXPERIMENTAL

Syrup 10-15 mg/kg/dosage every 6-8 hours as needed and do not exceed more than 5 doses in 24 hours Duration 1 week

Drug: Acetaminophen

ibuprofen

ACTIVE COMPARATOR

Syrup 4-10 mg/kg/dosage every 4-6 hours as needed and do not exceed more than 5 doses in 24 hours Duration 1 week

Drug: Ibuprofen

Interventions

Acetaminophen DRUG

Prescribe the drug to the child

Also known as: Paracetamol

Acetaminophen

Ibuprofen DRUG

Prescribe the drug to the child

Also known as: Brufin

ibuprofen

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- 1. Children with clinical diagnosis with a celiac disease.
• \. presence of recurrent apthous ulcers.

You may not qualify if:

• \. History of allergy to any ingredient present in the drugs to be used for treatment.
• \. Children whose parents had no home or mobile phone to enable post-operative contact.
• \. Parent that who refuse to sign the informed consent.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Acetaminophen; Ibuprofen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Ahmed Elmotayam, PhD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Afnan O soubih, BDS

CONTACT

01099810634; afnan.osama@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 29, 2023
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share