NCT06657066

EFFECTIVENESS of PROBIOTICS in ADULTS with MODERATE to SEVERE PERSISTENT ASTHMA

EFFECTIVENESS of PROBIOTIC AS an ADJUVANT to STANDARD THERAPY VERSUS STANDARD THERAPY ALONE in ADULTS with MODERATE to SEVERE PERSISTENT ASTHMA

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: King Edward Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the effectiveness of probiotic as an adjuvant to standard therapy versus standard therapy alone in adult with moderate to severe persistent asthma in terms of 1. Frequency of asthma exacerbations in terms of number of asthma attacks and severity of each episode. 2. Improvement in pulmonary function tests as recorded by an increase in FEV1 and FEV1/FVC ratio. 5\. HYPOTHESIS Probiotics as an adjuvant to standard therapy is more effective as compared to the standard therapy alone in managing moderate to severe persistent bronchial asthma.

Detailed description

Design of Study This was a Randomized controlled trial Follow up protocol The patient was evaluated at the beginning of the study, and then again at one and three months following enrolment for a follow-up evaluation of the main and secondary outcomes. Primary outcome To assess the frequency of exacerbations within 3 months. Secondary outcome: To observe improvement in 1\. FEV1 and the FEV1/FVC ratio. Improvement in one step and more than 12% Improvement in FEV1 from baseline. Improvement in asthma control test. Sample Size - The calculated sample size is 74 individuals (37 in each category i.e Intervention \& Control arm) Sampling technique - Simple random sampling Sample selection Inclusion Criteria 1. Patients of both genders between the ages of 18 and 80 years. 2. Diagnosed cases of moderate to severe persistent asthma, as determined by ACT Score and FEV1/FVC ratio as per operational definition. Exclusion Criteria 1. Patients with Mild asthma. 2. Pregnant females. 3. Patients who have taken fiber supplement or probiotics during the last four weeks. 4. Other pulmonary disorders, such as Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis (ABPA), chest wall deformities, bronchiectasis, pulmonary fibrosis, and lung cancer. 5. Asthma and chronic obstructive pulmonary disease overlap syndrome (ACOS).

Conditions

• Asthma Patients

Interventions

Type	Name	Description
DRUG	Beclomethasone 200mcg, salbutamol 100mcg , Beclomethasone 200 mcg/Formoterol 6 mcg, 250 mg of lyophilized saccharomyces boulardii	Daily low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram as needed Short acting beta 2 agonist (SABA)/salbutamol 100mcg ,OR as needed low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram -Long acting Beta2 Agonist (LABA)/Formeterol 6 microgram plus Saccharomyces boulardii, available in sachet from employed in this research containing 250 mg of lyophilized saccharomyces boulardii. It was given daily for three months
DRUG	Control (Standard treatment)	The control arm will receive only standard treatment for asthma i.e Daily low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram as needed Short acting beta 2 agonist (SABA)/salbutamol 100mcg ,OR as needed low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram -Long acting Beta2 Agonist (LABA)/Formeterol 6 microgram.

Timeline

• Start date: 2021-12-06
• Primary completion: 2022-04-24
• Completion: 2023-08-08
• First posted: 2024-10-24
• Last updated: 2024-10-24

Locations

1 site across 1 country: Pakistan