A Randomized Double-Blind Controlled Study Comparing the Effects of Probiotic Adjuvant Therapy on the Improvement of Lung Function and Blood Sugar in Patients with Type 2 Diabetes and Chronic Obstruction Pulmonary Disease

Glac Biotech Co., Ltd1 site in 1 country120 target enrollmentSeptember 19, 2022

ConditionsType 2 Diabetes Chronic Obstructive Pulmonary Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: Glac Biotech Co., Ltd
Enrollment: 120
Locations: 1
Primary Endpoint: Changes in concentration of glycated hemoglobin (HbA1c).
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is a randomized, double-blind, parallel placebo clinical trial, the purpose of which is to investigate whether the adjuvant therapy of using probiotics during the treatment of diabetic patients can decrease blood sugar levels significantly in comparison with placebo, and observe if the reduced lung function could be recovered in patients with type 2 diabetes (T2DM) and chronic obstructive pulmonary disease (COPD) simultaneously.

Registry

clinicaltrials.gov

Start Date

September 19, 2022

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Glac Biotech Co., Ltd

Responsible Party

Principal Investigator

Hsieh-Hsun Ho

R&D Director

Glac Biotech Co., Ltd

Eligibility Criteria

Inclusion Criteria

•Subjects are between 50-85 years old, and clinical diagnosis of T2DM (HbA1c ≥ 6.5% or fasting plasma glucose ≥ 126 mg/dL or oral glucose tolerance test 2-hour plasma glucose ≥ 200 mg/dL).
•Patients with stable pulmonary obstruction (pulmonary function FEV1/FVC \<0.7) with symptoms of pulmonary obstruction.
•Subjects can cooperate with the collection of experimental specimens and return for regular visits.
•The patient or family members have signed the informed consent form.
•The patient must receive adjuvant treatment with probiotic for 12 weeks.

Exclusion Criteria

•The patient or caregiver is unable to follow the physician's instructions for the trial, including the completed symptom assessment form and compliance with medication.
•The patient has a history of related allergic reactions, or the use of other highly sensitive or contraindicated drugs (Allergy to antibiotics or antipyretics).
•The patient have taken oral immunosuppressive drugs, intravenous steroids or T cell inhibitor ointments within the past 2 weeks.
•The patient has consumed probiotic-related products (including drops, lozenges, capsules, powder and yogurt) within the past 1 month.
•The patient received high doses of steroids within the past 1 month.
•The patient with active infection or severe pulmonary disease (eg, tuberculosis, bronchiectasis, or fibrosis).
•The patient is receiving treatment for a major disease or congenital disease.
•The patient is not suitable to participate in the trial as assessed by the professional physician.

Outcomes

Primary Outcomes

Changes in concentration of glycated hemoglobin (HbA1c).

Time Frame: Before and after 4-, 12-week intervention.

Changes in concentration of HbA1c were assessed before and after 4-, 12-week intervention.

Changes in ratio of forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC).

Time Frame: Before and after 4-, 12-week intervention.

Changes in ratio of FEV1/FVC were assessed by bronchodilator test before and after 4-, 12-week intervention.

Secondary Outcomes

Changes in scores of modified medical research council (mMRC).(Before and after 4-, 12-week intervention.)
Changes in scores of COPD assessment test (CAT).(Before and after 4-, 12-week intervention.)
Changes of the composition in gut microbiota.(Before and after 12-week intervention.)
Changes in concentration of immune cytokines.(Before and after 4-, 12-week intervention.)
Changes of the composition in lower respiratory tract microbiota.(Before and after 12-week intervention.)
Changes of concentration in short-chain fatty acid (SCFA) on plasma.(Before and after 12-week intervention.)
Changes of concentration in short-chain fatty acid (SCFA) on stool.(Before and after 12-week intervention.)
Changes in scores of modified Bristol stool form scale.(Before and after 4-, 12-week intervention.)
Changes in concentration of fasting blood sugar.(Before and after 4-, 12-week intervention.)