EFFECTIVENESS of PROBIOTICS in ADULTS with MODERATE to SEVERE PERSISTENT ASTHMA

King Edward Medical University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Asthma Patients

Treatments: Drug: Control (Standard treatment); Drug: Beclomethasone 200mcg, salbutamol 100mcg , Beclomethasone 200 mcg/Formoterol 6 mcg, 250 mg of lyophilized saccharomyces boulardii

Study type: Interventional

Funder types: Other

Identifiers

NCT06657066

6952/REG/KEMU/22MD200023

Details and patient eligibility

About

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.

3. 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.

Full 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).

Enrollment: 74 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

Intervention arm - Group A

Experimental group

Description:

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

Treatment:

Drug: Beclomethasone 200mcg, salbutamol 100mcg , Beclomethasone 200 mcg/Formoterol 6 mcg, 250 mg of lyophilized saccharomyces boulardii

Control arm- Group B

Placebo Comparator group

Description:

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

Treatment:

Drug: Control (Standard treatment)