Probiotic on Type 2 Diabetes and Chronic Obstruction Pulmonary Disease

NCT05492448 | Terminated

• 1 other identifier: EMRP12110N
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Chronic Obstructive Pulmonary Disease

Keywords

Diabetes mellitus; Chronic obstructive pulmonary disease; Gut microbiota; Probiotics

Outcome Measures

Primary Outcomes (2)

• Changes in concentration of glycated hemoglobin (HbA1c).

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

  Before and after 4-, 12-week intervention.

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

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

  Before and after 4-, 12-week intervention.

Secondary Outcomes (9)

• Changes in concentration of fasting blood sugar.

  Before and after 4-, 12-week intervention.

• Changes in concentration of immune cytokines.

  Before and after 4-, 12-week intervention.

• 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.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

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

EXPERIMENTAL

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

L. reuteri GL-104

EXPERIMENTAL

Dietary Supplement: L. reuteri GL-104

Interventions

Placebo DIETARY_SUPPLEMENT

Subjects take one pack containing maltodextrin twice daily after breakfast and dinner.

Placebo

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

Subjects take one pack containing L. salivarius AP-32 and L. reuteri GL-104 twice daily after breakfast and dinner.

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

L. reuteri GL-104 DIETARY_SUPPLEMENT

Subjects take one pack containing L. reuteri GL-104 twice daily after breakfast and dinner.

L. reuteri GL-104

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glac Biotech Co., Ltd: lead

Study Sites (1)

Glac Biotech Co., Ltd.

Tainan, 74442, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: R&D Director

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 8, 2022
• Study Start: September 19, 2022
• Primary Completion: August 15, 2025
• Study Completion: December 31, 2025
• Last Updated: February 27, 2026

Record last verified: 2025-03

Locations

TW (1)