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

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.

Study Overview

• Status: Completed
• Conditions: Asthma Patients
• Intervention / Treatment: Drug: Beclomethasone 200mcg, salbutamol 100mcg , Beclomethasone 200 mcg/Formoterol 6 mcg, 250 mg of lyophilized saccharomyces boulardii; Drug: Control (Standard treatment)

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).

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • King Edward Medical University, Neelagumbad, Anarkali, Lahore, Pakistan. Postal Code: 54000 Telephone: +92 (42) 99211145-54

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Patient 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 supplements 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm - Group A; Standar Therapy- 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. Along with Probiotics i.e Saccharomyces boulardii, available in sachet from employed in this research containing 250 mg of lyophilized saccharomyces boulardii	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; Other Names: Group A
Placebo Comparator: Control arm- Group B; Standard therapy only: 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	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.; Other Names: Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequencies of exacerbation	Assessment of the frequency of exacerbations within 3 months will be observed among the intervention & control grouo	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvment of FEV1 and FEV1/FVC ratio	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.	3 months

Collaborators and Investigators

• Sponsor: King Edward Medical University
• Investigators: Principal Investigator: Dr. Binayak Singh, MD, King Edward Medical University Lahore

Publications and helpful links

Helpful Links

• Clinical and molecular phenotypes of asthma are complex. The main phenotypes of adult asthma are characterized by eosinophil and/or neutrophil cell dominant airway inflammation that represent distinct clinical features. Upper and lower airways constitute

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Actual): April 24, 2022
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: October 19, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Asthma; Probiotics; adjuvant; Standard Therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Autonomic Agents; Peripheral Nervous System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Reproductive Control Agents; Neurotransmitter Agents; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Formoterol Fumarate; Albuterol; Beclomethasone
• Other Study ID Numbers: 6952/REG/KEMU/22MD200023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only the principal investigator, supervisor, and Institution Review Board will have access with patients data upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No