Celiac Disease in ChildrenPhase 4NCT06149507
Effect of Acetaminophen Versus Ibuprofen in Treating Recurrent Apthous Ulcers in Pediatric Celiac Disease
A Phase 4 study testing Acetaminophen and Ibuprofen in people with Celiac Disease in Children, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease in Children
- What is being tested?
- Acetaminophen and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Children with clinical diagnosis with a celiac disease.
- 2. presence of recurrent apthous ulcers.
Who cannot join
- 1. History of allergy to any ingredient present in the drugs to be used for treatment.
- 2. Children whose parents had no home or mobile phone to enable post-operative contact.
- 3. Parent that who refuse to sign the informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Acetaminophen Versus Ibuprofen in Treating Recurrent Apthous Ulcers in Pediatric Celiac Disease: A Randomized Pilot Study
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.
Read the detailed description
Celiac disease is an immune-mediated systemic disease triggered by intake of gluten in genetically susceptible individuals. The prevalence of celiac disease in the general population is estimated to be 1% in the world. Its prevalence differs depending on geographical and ethnic variations. The prevalence of celiac disease has increased significantly in the last 30 years due to the increased knowledge and awareness of physicians and the widespread use of highly sensitive and specific diagnostic tests for celiac disease.
Despite increased awareness and knowledge about celiac disease, up to 95% of celiac patients still remain undiagnosed. The presentations of celiac disease have significantly changed in the last few decades.
Classical symptoms of celiac disease occur in a minority of celiac patients, while older children have either minimal or atypical symptoms. Serologic tests for celiac disease should be done in patients with unexplained chronic or intermittent diarrhea, failure to thrive, weight loss, delayed puberty, short stature, amenorrhea, iron deficiency anemia, nausea, vomiting, chronic abdominal pain, abdominal distension, chronic constipation, recurrent aphthous stomatitis, and abnormal liver enzyme elevation, and in children who belong to specific groups at risk. Early diagnosis of celiac disease is very important to prevent long-term complications. Currently, the only effective treatment is a lifelong gluten-free diet. In this review, we will discuss the epidemiology, clinical findings, diagnostic tests, and treatment of celiac disease in the light of the latest literature.
When designing a clinical trial an appropriate justification for the sample size should be provided in the protocol. This justification could be based on formal power calculations or on other considerations such as the precision of the estimates of interest . However, there are a number of settings when designing a pilot investigation where there is no prior information upon which to base the sample size. For example, in phase I the study could be a bioavailability study for a new chemical entity, while for a later phase the study could be with a novel endpoint or in a previously unstudied group of patients (for the compound).
Of the four available studies of propranolol, two showed increased serum concentration levels in patients with celiac disease relative to those without celiac disease,12,23 one showed more rapid absorption with similar peak concentrations,24 and one showed no changes in peak concentrations or overall absorption but a reduction in jejunal absorption.22 Some inconsistencies in the results could be explained by slight differences in study protocols; specifically, the length of time study participants fasted before and after study drug administration, as well as variations in the temperature at which blood samples were stored (4C versus -20C) prior to testing, could have contributed to the dissimilarity of the results reported.
In general, it appears that some degree of altered absorption occurs with propranolol use in patients with celiac disease, but whether or not this translates to altered clinical outcomes is unknown and should be evaluated.
Until future trials studying these clinical effects directly, it may be prudent to initiate certain drugs at lower doses and implement dosage adjustments more cautiously in patients with celiac disease.
The earlier peak concentrations reported with aspirin and propranolol use and the increased overall AUC values reported for propranolol, cephalexin, clindamycin, sulfamethoxazole, trimethoprim, and methyldopa run counter to the general assumption that drug malabsorption occurs in patients
- Conditions
- Celiac Disease in Children
- Being tested
- Acetaminophen, Ibuprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Paracetamol
Prescribe the drug to the child
IbuprofenDrug
Also called Brufin
Prescribe the drug to the child
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain intensity
faces pain scale score (from no pain [score 0] to maximum pain intensity [score 10] )
Measured: 6 month
Secondary outcomes (4)
presence of recurrent apthous ulcer
clinical observation complement by history from parents by yes or no
Measured: baseline, before intervention
Occurrence of Dental enamel defects (DED)
Aine ' s classification of dental enamel defect score (0-4) dental enamel defects
Measured: baseline, before intervention
Dental caries experience
CAST index (score"0: sound", "1: sealant", "2: restoration", "3: enamel lesions", "4,5: dentine lesions", "6: pulp involvement", "7: abscess/fistula", "8: tooth loss". if a situation did not match any code from 0 to 8, a code 9 was assigned.)
l
Measured: baseline, before intervention
Delayed dental eruption
number of teeth with delayed eruption
Measured: baseline, before intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afnan Osama Abdelnaby, Cairo University
- Investigators
- Ahmed Elmotayam, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149507
- Sponsor's protocol ID
- 14422021417131
- Status last verified
- Dec 2023
- First submitted
- 9 Nov 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acetaminophen Versus Ibuprofen in Treating Recurrent Apthous Ulcers in Pediatric Celiac Disease: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT06149507
- Acronym / sponsor ID
- 14422021417131
- Conditions
- Celiac Disease in Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Celiac disease is an immune-mediated systemic disease triggered by intake of gluten in genetically susceptible individuals. The prevalence of celiac disease in the general population is estimated to be 1% in the world. Its prevalence differs depending on geographical and ethnic variations. The prevalence of celiac disease has increased significantly in the last 30 years due to the increased knowledge and awareness of physicians and the widespread use of highly sensitive and specific diagnostic tests for celiac disease.
Despite increased awareness and knowledge about celiac disease, up to 95% of celiac patients still remain undiagnosed. The presentations of celiac disease have significantly changed in the last few decades.
Classical symptoms of celiac disease occur in a minority of celiac patients, while older children have either minimal or atypical symptoms. Serologic tests for celiac disease should be done in patients with unexplained chronic or intermittent diarrhea, failure to thrive, weight loss, delayed puberty, short stature, amenorrhea, iron deficiency anemia, nausea, vomiting, chronic abdominal pain, abdominal distension, chronic constipation, recurrent aphthous stomatitis, and abnormal liver enzyme elevation, and in children who belong to specific groups at risk. Early diagnosis of celiac disease is very important to prevent long-term complications. Currently, the only effective treatment is a lifelong gluten-free diet. In this review, we will discuss the epidemiology, clinical findings, diagnostic tests, and treatment of celiac disease in the light of the latest literature.
When designing a clinical trial an appropriate justification for the sample size should be provided in the protocol. This justification could be based on formal power calculations or on other considerations such as the precision of the estimates of interest . However, there are a number of settings when designing a pilot investigation where there is no prior information upon which to base the sample size. For example, in phase I the study could be a bioavailability study for a new chemical entity, while for a later phase the study could be with a novel endpoint or in a previously unstudied group of patients (for the compound).
Of the four available studies of propranolol, two showed increased serum concentration levels in patients with celiac disease relative to those without celiac disease,12,23 one showed more rapid absorption with similar peak concentrations,24 and one showed no changes in peak concentrations or overall absorption but a reduction in jejunal absorption.22 Some inconsistencies in the results could be explained by slight differences in study protocols; specifically, the length of time study participants fasted before and after study drug administration, as well as variations in the temperature at which blood samples were stored (4C versus -20C) prior to testing, could have contributed to the dissimilarity of the results reported.
In general, it appears that some degree of altered absorption occurs with propranolol use in patients with celiac disease, but whether or not this translates to altered clinical outcomes is unknown and should be evaluated.
Until future trials studying these clinical effects directly, it may be prudent to initiate certain drugs at lower doses and implement dosage adjustments more cautiously in patients with celiac disease.
The earlier peak concentrations reported with aspirin and propranolol use and the increased overall AUC values reported for propranolol, cephalexin, clindamycin, sulfamethoxazole, trimethoprim, and methyldopa run counter to the general assumption that drug malabsorption occurs in patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen | Experimental | Drug: AcetaminophenSyrup 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 |
| ibuprofen | Active comparator | Drug: IbuprofenSyrup 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 |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 1. Children with clinical diagnosis with a celiac disease.
- 2. presence of recurrent apthous ulcers.
Key exclusion criteria (3 listed)
- 1. History of allergy to any ingredient present in the drugs to be used for treatment.
- 2. Children whose parents had no home or mobile phone to enable post-operative contact.
- 3. Parent that who refuse to sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenAlso: ParacetamolPrescribe the drug to the child | Drug | Acetaminophen |
| IbuprofenAlso: BrufinPrescribe the drug to the child | Drug | ibuprofen |
Primary outcome
change in pain intensity
Time frame: 6 month
faces pain scale score (from no pain [score 0] to maximum pain intensity [score 10] )
4 secondary outcomes
presence of recurrent apthous ulcer
Time frame: baseline, before intervention
Occurrence of Dental enamel defects (DED)
Time frame: baseline, before intervention
Dental caries experience
Time frame: baseline, before intervention
Delayed dental eruption
Time frame: baseline, before intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Celiac Disease in Children
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
Enrolling by invitation
Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
Celiac Disease in Children, Nutritional Assessment
Active, not recruiting
Celiac Disease in Childhood-Adulthood Transition
Celiac Disease, Celiac Disease in Children
Enrolling by invitation
Immune Responses to Gluten
Celiac Disease, Malabsorption Syndromes
RecruitingObservational study
Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease
Celiac Disease in Children, Celiac Disease in Adolescents
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Elmotayam, PhD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen and Ibuprofen in people with Celiac Disease in Children, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Afnan O soubih, BDS (01099810634, afnan.osama@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pain intensity (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.