Impact of Modified Specific Carbohydrate Diet on Bronchial Asthma Control in Children
NCT ID: NCT05728385
Last Updated: 2023-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-08-01
2024-03-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Modified SPD as adjunct to asthma medications in children
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.
Modified Specific carbohydrate diet for 3 months
All 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
Usual asthma medications only in children with moderate asthma
Assess control based on the usual asthma medications only
No interventions assigned to this group
Interventions
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Modified Specific carbohydrate diet for 3 months
All 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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
6 Years
18 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Rehab Zaki Elmeazawy
Doctor
Central Contacts
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References
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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.
Bedard 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.
Beasley 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.
Julia 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.
Guilleminault 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.
Loverdos 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.
Wahbeh 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.
Suskind 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.
National 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.
Liu 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.
Other Identifiers
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mSCD in Asthmatic children
Identifier Type: -
Identifier Source: org_study_id
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