Probiotic on Type 2 Diabetes and Chronic Obstruction Pulmonary Disease

glac Biotech

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease; Type 2 Diabetes

Treatments: Dietary Supplement: L. reuteri GL-104; Dietary Supplement: L. salivarius AP-32 and L. reuteri GL-104; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05492448

EMRP12110N

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

L. salivarius AP-32 and L. reuteri GL-104

Experimental group

Treatment:

Dietary Supplement: L. salivarius AP-32 and L. reuteri GL-104

L. reuteri GL-104

Experimental group

Treatment:

Dietary Supplement: L. reuteri GL-104