Impact of Modified Specific Carbohydrate Diet on Bronchial Asthma Control in Children

NCT05728385 | Unknown

• 1 other identifier: mSCD in Asthmatic children
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Asthma in Children

Keywords

Asthma; Children; Dietary therapy; Specific carbohydrate diet

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline (three months)

Secondary Outcomes (3)

• FEV1

  three months

• FVC

  three months

• FEV1/FVC ratio

  three months

Study Arms (2)

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.

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

Interventions

Modified Specific carbohydrate diet for 3 months DIETARY_SUPPLEMENT

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

Modified SPD as adjunct to asthma medications in children

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Related Publications (10)

• 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.

  PMID: 34718211 BACKGROUND

• 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.

  PMID: 33804200 BACKGROUND

• 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.

  PMID: 26382999 BACKGROUND

• 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.

  PMID: 25907459 BACKGROUND

• 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.

  PMID: 29117118 BACKGROUND

• 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.

  PMID: 31739446 BACKGROUND

• 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.

  PMID: 28825776 BACKGROUND

• 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.

  PMID: 33291229 BACKGROUND

• 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.

  PMID: 17983880 BACKGROUND

• 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.

  PMID: 17353040 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Rehab Z Elmeazawy, MD

CONTACT

01004815280; rehab.elmeazawy@med.tanta.edu.eg

Amany M Elbarky, MD

CONTACT

01065658386; amanyelbarky83@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 15, 2023
• Study Start: August 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: March 30, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07