Clinical trial NCT05492448: Probiotic on Type 2 Diabetes and Chronic Obstruction Pulmonary Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Chronic Obstructive Pulmonary Disease
Keywords: Diabetes mellitus
Chronic obstructive pulmonary disease
Gut microbiota
Probiotics
Lead sponsor: Glac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in concentration of glycated hemoglobin (HbA1c).
timeFrame: Before and after 4-, 12-week intervention.
measure: Changes in ratio of forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC).
timeFrame: Before and after 4-, 12-week intervention.
Secondary outcomes:
measure: Changes in concentration of fasting blood sugar.
timeFrame: Before and after 4-, 12-week intervention.
measure: Changes in concentration of immune cytokines.
timeFrame: Before and after 4-, 12-week intervention.
measure: Changes in scores of modified medical research council (mMRC).
timeFrame: Before and after 4-, 12-week intervention.
measure: Changes in scores of COPD assessment test (CAT).
timeFrame: Before and after 4-, 12-week intervention.
measure: Changes of the composition in gut microbiota.
timeFrame: Before and after 12-week intervention.
measure: Changes of the composition in lower respiratory tract microbiota.
timeFrame: Before and after 12-week intervention.
measure: Changes of concentration in short-chain fatty acid (SCFA) on plasma.
timeFrame: Before and after 12-week intervention.
measure: Changes of concentration in short-chain fatty acid (SCFA) on stool.
timeFrame: Before and after 12-week intervention.
measure: Changes in scores of modified Bristol stool form scale.
timeFrame: Before and after 4-, 12-week intervention.
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: Glac Biotech Co., Ltd.
Study officials:
References: