Using probiotics to improve blood sugar and lung function in diabetes and COPD patients

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

This study is testing whether taking probiotics can help people with Type 2 Diabetes and COPD lower their blood sugar and breathe better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: Glac Biotech Co., Ltd (industry)
• Locations: 1 site (Tainan City)
• Trial ID: NCT05492448 on ClinicalTrials.gov

What this trial studies

This trial investigates the effects of probiotics as an adjuvant therapy in patients with Type 2 Diabetes and Chronic Obstructive Pulmonary Disease. It is a randomized, double-blind, parallel placebo clinical trial designed to compare the efficacy of probiotics against a placebo in reducing blood sugar levels and improving lung function. Participants will receive either the probiotics L. salivarius AP-32 and L. reuteri GL-104 or a placebo for a duration of 12 weeks. The study aims to determine if these probiotics can provide significant health benefits for individuals suffering from both conditions.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50-85 with a clinical diagnosis of Type 2 Diabetes and stable pulmonary obstruction.

Not a fit: Patients who are unable to comply with study protocols or have a history of allergic reactions to the study medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of blood sugar levels and lung function in patients with Type 2 Diabetes and COPD.

How similar studies have performed: While the use of probiotics in diabetes management has been explored, this specific combination and approach in patients with both diabetes and COPD is relatively novel.

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.

Where this trial is running

Tainan City

• Glac Biotech Co., Ltd. — Tainan City, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Yu-Feng Wei, M.D., Ph.D

Conditions: Type 2 Diabetes, Chronic Obstructive Pulmonary Disease, Diabetes mellitus, Chronic obstructive pulmonary disease, Gut microbiota, Probiotics