Asthma in ChildrenNCT05728385
Impact of Modified Specific Carbohydrate Diet on Bronchial Asthma Control in Children
A study testing Modified Specific carbohydrate diet for 3 months in people with Asthma in Children, run by Tanta University.
Trial summary
The aim of this study will explore if the specific carbohydrate diet has an effect on asthma control in children and if it will affect the frequency, severity, and duration of asthma and thus provide it as a potential complementary treatment option for them. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Modified Specific carbohydrate diet for 3 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Mar 2024
- Phase
- Interventional
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Asthmatic children with moderate persistent asthma according to the definition of National Heart, Lung, and Blood Institute guidelines, if they have daily symptoms, nighttime awakenings more than 1 time/week, but not nightly, daily use of short-acting beta-agonist for symptom control, some limitations of normal activities, and Forced Expiratory Volume in 1 second (FEV1)60-80%.
- Children aged from 6 to 18 years.
- The children are included only if parents and children are strongly motivated to try a dietary intervention (mSCD) as a complementary treatment.
Who cannot join
- Children with chronic lung disease, immunodeficiency, major thoracic deformities, neuromuscular, cardiovascular, digestive, rheumatic, osteoarticular, or genetic syndromes or any adverse health conditions that can affect nutritional status were excluded from the study.
- Children excluded if parents and children are not motivated to try a dietary intervention (mSCD) as a complementary treatment or who failed to have regular outpatient follow-up visits.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study will explore if the specific carbohydrate diet has an effect on asthma control in children and if it will affect the frequency, severity, and duration of asthma and thus provide it as a potential complementary treatment option for them.
Read the detailed description
This study will be carried out on 30 children with moderate persistent asthma presented to the outpatient clinic of the Pulmonology Unit, Pediatric Department, Tanta University Hospital.
All children at the start of the study will be subjected to full history taking including, full nutritional assessment, laboratory tests, Pulmonary function tests, and Anthropometric measurements
- Conditions
- Asthma in Children
- Being tested
- Modified Specific carbohydrate diet for 3 months
- Keywords
- Asthma, Children, Dietary therapy, Specific carbohydrate diet
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Specific carbohydrate diet for 3 monthsDietary supplement
All children at the start of the study will be subjected to:
- Full history taking including demographic and medical history
- Full nutritional assessment including: Through clinical examination for any signs of vitamins and mineral deficiency, with full chest examination.
- Laboratory tests: Complete blood picture with differential white blood cells, and Serum IgE level
- At the beginning of the study and at the end
- The patients will be assessed using the childhood-asthma control test (C-ACT) as a subjective method
- Pulmonary function tests will be performed using spirometry (Spirostik, Geratherm) that includes Forced vital capacity (FVC), forced expiratory volume in the first second of FVC (FEV1), and FEV1/FVC.
- Anthropometric measurements: Weight, Height, and Body mass index (BMI). All measures will be plotted on specific percentile curves for age and Z score
| Study group | Role | What they receive |
|---|---|---|
| Modified SPD as adjunct to asthma medications in children | Experimental | Explore if the modified specific carbohydrate diet has an effect on asthma control in children and if it will affect the frequency, severity, and duration of asthma and thus provide it as a potential complementary treatment option for them. Receives: Dietary Supplement: Modified Specific carbohydrate diet for 3 months |
| Usual asthma medications only in children with moderate asthma | No intervention | Assess control based on the usual asthma medications only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childhood-asthma control test (C-ACT) as a subjective method
The C-ACT consists of a 7-item validated questionnaire, addresses the previous 4 weeks and is divided into two parts. One part is filled in by the child and consists of four questions on perception of asthma control, limitation of activities, coughing and awakenings at night. Each question has four response options. The second part is filled in by the parent or caregiver and consists of three questions (daytime complaints, daytime wheezing and awakenings at night) with six response options. The sum of all scores yields the C-ACT score, ranging from 0 (poorest asthma control) to 27 (optimal asthma control). A cut-off point ≤ 19indicates uncontrolled asthma
Measured: Baseline (three months)
Secondary outcomes (3)
FEV1
Will be performed using spirometry (Spirostik, Geratherm) to measure forced expiratory volume at the end of the first second.
Measured: three months
FVC
Will be performed using spirometry (Spirostik, Geratherm) to measure forced vital capacity.
Measured: three months
FEV1/FVC ratio
Will be performed using spirometry (Spirostik, Geratherm) to measure the ratio of forced expiratory volume at the end of first second to the forced vital capacity.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Jan 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Zaki Elmeazawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728385
- Sponsor's protocol ID
- mSCD in Asthmatic children
- Status last verified
- Jul 2023
- First submitted
- 10 Jan 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reddel HK, Bacharier LB, Bateman ED, Brightling CE, Brusselle GG, Buhl R, Cruz AA, Duijts L, Drazen JM, FitzGerald JM, Fleming LJ, Inoue H, Ko FW, Krishnan JA, Levy ML, Lin J, Mortimer K, Pitrez PM, Sheikh A, Yorgancioglu AA, Boulet LP. Global Initiative for Asthma Strategy 2021: Executive Summary and Rationale for Key Changes. J Allergy Clin Immunol Pract. 2022 Jan;10(1S):S1-S18. doi: 10.1016/j.jaip.2021.10.001. Epub 2021 Oct 28.
PubMed 34718211Bedard A, Li Z, Ait-Hadad W, Camargo CA Jr, Leynaert B, Pison C, Dumas O, Varraso R. The Role of Nutritional Factors in Asthma: Challenges and Opportunities for Epidemiological Research. Int J Environ Res Public Health. 2021 Mar 15;18(6):3013. doi: 10.3390/ijerph18063013.
PubMed 33804200Beasley R, Semprini A, Mitchell EA. Risk factors for asthma: is prevention possible? Lancet. 2015 Sep 12;386(9998):1075-85. doi: 10.1016/S0140-6736(15)00156-7.
PubMed 26382999Julia V, Macia L, Dombrowicz D. The impact of diet on asthma and allergic diseases. Nat Rev Immunol. 2015 May;15(5):308-22. doi: 10.1038/nri3830.
PubMed 25907459Guilleminault L, Williams EJ, Scott HA, Berthon BS, Jensen M, Wood LG. Diet and Asthma: Is It Time to Adapt Our Message? Nutrients. 2017 Nov 8;9(11):1227. doi: 10.3390/nu9111227.
PubMed 29117118Loverdos K, Bellos G, Kokolatou L, Vasileiadis I, Giamarellos E, Pecchiari M, Koulouris N, Koutsoukou A, Rovina N. Lung Microbiome in Asthma: Current Perspectives. J Clin Med. 2019 Nov 14;8(11):1967. doi: 10.3390/jcm8111967.
PubMed 31739446Wahbeh GT, Ward BT, Lee DY, Giefer MJ, Suskind DL. Lack of Mucosal Healing From Modified Specific Carbohydrate Diet in Pediatric Patients With Crohn Disease. J Pediatr Gastroenterol Nutr. 2017 Sep;65(3):289-292. doi: 10.1097/MPG.0000000000001619.
PubMed 28825776Suskind DL, Lee D, Kim YM, Wahbeh G, Singh N, Braly K, Nuding M, Nicora CD, Purvine SO, Lipton MS, Jansson JK, Nelson WC. The Specific Carbohydrate Diet and Diet Modification as Induction Therapy for Pediatric Crohn's Disease: A Randomized Diet Controlled Trial. Nutrients. 2020 Dec 6;12(12):3749. doi: 10.3390/nu12123749.
PubMed 33291229National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.
PubMed 17983880Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.
PubMed 17353040
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Modified Specific Carbohydrate Diet on Bronchial Asthma Control in Children
- ClinicalTrials.gov ID
- NCT05728385
- Acronym / sponsor ID
- mSCD in Asthmatic children
- Conditions
- Asthma in Children
- Keywords
- Asthma, Children, Dietary therapy, Specific carbohydrate diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 15 Feb 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.
The aim of this study will explore if the specific carbohydrate diet has an effect on asthma control in children and if it will affect the frequency, severity, and duration of asthma and thus provide it as a potential complementary treatment option for them.
Detailed description
This study will be carried out on 30 children with moderate persistent asthma presented to the outpatient clinic of the Pulmonology Unit, Pediatric Department, Tanta University Hospital.
All children at the start of the study will be subjected to full history taking including, full nutritional assessment, laboratory tests, Pulmonary function tests, and Anthropometric measurements
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified SPD as adjunct to asthma medications in children | Experimental | Dietary Supplement: Modified Specific carbohydrate diet for 3 monthsExplore if the modified specific carbohydrate diet has an effect on asthma control in children and if it will affect the frequency, severity, and duration of asthma and thus provide it as a potential complementary treatment option for them. |
| Usual asthma medications only in children with moderate asthma | No intervention | –Assess control based on the usual asthma medications only |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Asthmatic children with moderate persistent asthma according to the definition of National Heart, Lung, and Blood Institute guidelines, if they have daily symptoms, nighttime awakenings more than 1 time/week, but not nightly, daily use of short-acting beta-agonist for symptom control, some limitations of normal activities, and Forced Expiratory Volume in 1 second (FEV1)60-80%.
- Children aged from 6 to 18 years.
- The children are included only if parents and children are strongly motivated to try a dietary intervention (mSCD) as a complementary treatment.
Key exclusion criteria (2 listed)
- Children with chronic lung disease, immunodeficiency, major thoracic deformities, neuromuscular, cardiovascular, digestive, rheumatic, osteoarticular, or genetic syndromes or any adverse health conditions that can affect nutritional status were excluded from the study.
- Children excluded if parents and children are not motivated to try a dietary intervention (mSCD) as a complementary treatment or who failed to have regular outpatient follow-up visits.
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 |
|---|---|---|
| Modified Specific carbohydrate diet for 3 monthsAll children at the start of the study will be subjected to: 1. Full history taking including demographic and medical history 2. Full nutritional assessment including: Through clinical examination for any signs of vitamins and mineral deficiency, with full chest examination. 3. Laboratory tests: Complete blood picture with differential white blood cells, and Serum IgE level 4. At the beginning of the study and at the end 1. The patients will be assessed using the childhood-asthma control test (C-ACT) as a subjective method 2. Pulmonary function tests will be performed using spirometry (Spirostik, Geratherm) that includes Forced vital capacity (FVC), forced expiratory volume in the first second of FVC (FEV1), and FEV1/FVC. 3. Anthropometric measurements: Weight, Height, and Body mass index (BMI). All measures will be plotted on specific percentile curves for age and Z score | Dietary supplement | Modified SPD as adjunct to asthma medications in children |
Primary outcome
Childhood-asthma control test (C-ACT) as a subjective method
Time frame: Baseline (three months)
The C-ACT consists of a 7-item validated questionnaire, addresses the previous 4 weeks and is divided into two parts. One part is filled in by the child and consists of four questions on perception of asthma control, limitation of activities, coughing and awakenings at night. Each question has four response options. The second part is filled in by the parent or caregiver and consists of three questions (daytime complaints, daytime wheezing and awakenings at night) with six response options. The sum of all scores yields the C-ACT score, ranging from 0 (poorest asthma control) to 27 (optimal asthma control). A cut-off point ≤ 19indicates uncontrolled asthma
3 secondary outcomes
FEV1
Time frame: three months
FVC
Time frame: three months
FEV1/FVC ratio
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Background: PubMed 34718211Reddel HK, Bacharier LB, Bateman ED, Brightling CE, Brusselle GG, Buhl R, Cruz AA, Duijts L, Drazen JM, FitzGerald JM, Fleming LJ, Inoue H, Ko FW, Krishnan JA, Levy ML, Lin J, Mortimer K, Pitrez PM, Sheikh A, Yorgancioglu AA, Boulet LP. Global Initiative for Asthma Strategy 2021: Executive Summary and Rationale for Key Changes. J Allergy Clin Immunol Pract. 2022 Jan;10(1S):S1-S18. doi: 10.1016/j.jaip.2021.10.001. Epub 2021 Oct 28.
- Background: PubMed 33804200Bedard A, Li Z, Ait-Hadad W, Camargo CA Jr, Leynaert B, Pison C, Dumas O, Varraso R. The Role of Nutritional Factors in Asthma: Challenges and Opportunities for Epidemiological Research. Int J Environ Res Public Health. 2021 Mar 15;18(6):3013. doi: 10.3390/ijerph18063013.
- Background: PubMed 26382999Beasley R, Semprini A, Mitchell EA. Risk factors for asthma: is prevention possible? Lancet. 2015 Sep 12;386(9998):1075-85. doi: 10.1016/S0140-6736(15)00156-7.
- Background: PubMed 25907459Julia V, Macia L, Dombrowicz D. The impact of diet on asthma and allergic diseases. Nat Rev Immunol. 2015 May;15(5):308-22. doi: 10.1038/nri3830.
- Background: PubMed 29117118Guilleminault L, Williams EJ, Scott HA, Berthon BS, Jensen M, Wood LG. Diet and Asthma: Is It Time to Adapt Our Message? Nutrients. 2017 Nov 8;9(11):1227. doi: 10.3390/nu9111227.
- Background: PubMed 31739446Loverdos K, Bellos G, Kokolatou L, Vasileiadis I, Giamarellos E, Pecchiari M, Koulouris N, Koutsoukou A, Rovina N. Lung Microbiome in Asthma: Current Perspectives. J Clin Med. 2019 Nov 14;8(11):1967. doi: 10.3390/jcm8111967.
- Background: PubMed 28825776Wahbeh GT, Ward BT, Lee DY, Giefer MJ, Suskind DL. Lack of Mucosal Healing From Modified Specific Carbohydrate Diet in Pediatric Patients With Crohn Disease. J Pediatr Gastroenterol Nutr. 2017 Sep;65(3):289-292. doi: 10.1097/MPG.0000000000001619.
- Background: PubMed 33291229Suskind DL, Lee D, Kim YM, Wahbeh G, Singh N, Braly K, Nuding M, Nicora CD, Purvine SO, Lipton MS, Jansson JK, Nelson WC. The Specific Carbohydrate Diet and Diet Modification as Induction Therapy for Pediatric Crohn's Disease: A Randomized Diet Controlled Trial. Nutrients. 2020 Dec 6;12(12):3749. doi: 10.3390/nu12123749.
- Background: PubMed 17983880National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.
- Background: PubMed 17353040Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Specific carbohydrate diet for 3 months in people with Asthma in Children, run by Tanta 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 3 inclusion and 2 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 14 Jul 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.
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 Rehab Z Elmeazawy, MD (01004815280, rehab.elmeazawy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood-asthma control test (C-ACT) as a subjective method (time frame: Baseline (three months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05728385, which also lists 10 linked publications.
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 14 Jul 2023.