Probiotic on Type 2 Diabetes and Chronic Obstruction Pulmonary Disease
Primary Purpose
Type 2 Diabetes, Chronic Obstructive Pulmonary Disease
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo
L. salivarius AP-32 and L. reuteri GL-104
L. reuteri GL-104
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes mellitus, Chronic obstructive pulmonary disease, Gut microbiota, Probiotics
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.
Sites / Locations
- Glac Biotech Co., Ltd.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
L. salivarius AP-32 and L. reuteri GL-104
L. reuteri GL-104
Arm Description
Outcomes
Primary Outcome Measures
Changes in concentration of glycated hemoglobin (HbA1c).
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).
Changes in ratio of FEV1/FVC were assessed by bronchodilator test before and after 4-, 12-week intervention.
Secondary Outcome Measures
Changes in concentration of fasting blood sugar.
Changes in concentration of fasting blood sugar were assessed before and after 4-, 12-week intervention.
Changes in concentration of immune cytokines.
Changes in concentration of immune cytokines were assessed before and after 4-, 12-week intervention.
Changes in scores of modified medical research council (mMRC).
Changes in scores of mMRC were assessed before and after 4-, 12-week intervention. The minimum score is 0 and the maximum score is 4. A higher score means more difficult breathing.
Changes in scores of COPD assessment test (CAT).
Changes in scores of CAT were assessed before and after 4-, 12-week intervention. The minimum score is 0 and the maximum score is 40. A higher score means more seriously affect life.
Changes of the composition in gut microbiota.
Changes of the composition in gut microbiota were analyzed by next-generation sequencing (NGS) before and after 12-week intervention.
Changes of the composition in lower respiratory tract microbiota.
Changes of the composition in lower respiratory tract microbiota were analyzed by next-generation sequencing (NGS) before and after 12-week intervention.
Changes of concentration in short-chain fatty acid (SCFA) on plasma.
Changes of concentration in SCFA on plasma were analyzed by gas chromatography-mass spectrometry before and after 12-week intervention.
Changes of concentration in short-chain fatty acid (SCFA) on stool.
Changes of concentration in SCFA on stool were analyzed by gas chromatography-mass spectrometry before and after 12-week intervention.
Changes in scores of modified Bristol stool form scale.
Changes in scores of modified Bristol stool form scale were assessed before and after 4-, 12-week intervention. The questionnaire included the stool form [1 = very hard (small hard lumps), 2 = hard stool (hard sausage shape), 3 = normal stool (sausage to banana shape), 4 = soft stool, 5 = muddy stool, 6 = watery stool], ease of defecation (1 = difficult, 2 = easy, 3 = very easy) and abdominal symptoms [frequency of upper abdominal pain, lower abdominal pain, borborygmus, and flatulence (1 = frequent, 2 = occasional, 3 = almost never)].
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05492448
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glac Biotech Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Chronic Obstructive Pulmonary Disease
Keywords
Diabetes mellitus, Chronic obstructive pulmonary disease, Gut microbiota, Probiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
L. salivarius AP-32 and L. reuteri GL-104
Arm Type
Experimental
Arm Title
L. reuteri GL-104
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Subjects take one pack containing maltodextrin twice daily after breakfast and dinner.
Intervention Type
Dietary Supplement
Intervention Name(s)
L. salivarius AP-32 and L. reuteri GL-104
Intervention Description
Subjects take one pack containing L. salivarius AP-32 and L. reuteri GL-104 twice daily after breakfast and dinner.
Intervention Type
Dietary Supplement
Intervention Name(s)
L. reuteri GL-104
Intervention Description
Subjects take one pack containing L. reuteri GL-104 twice daily after breakfast and dinner.
Primary Outcome Measure Information:
Title
Changes in concentration of glycated hemoglobin (HbA1c).
Description
Changes in concentration of HbA1c were assessed before and after 4-, 12-week intervention.
Time Frame
Before and after 4-, 12-week intervention.
Title
Changes in ratio of forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC).
Description
Changes in ratio of FEV1/FVC were assessed by bronchodilator test before and after 4-, 12-week intervention.
Time Frame
Before and after 4-, 12-week intervention.
Secondary Outcome Measure Information:
Title
Changes in concentration of fasting blood sugar.
Description
Changes in concentration of fasting blood sugar were assessed before and after 4-, 12-week intervention.
Time Frame
Before and after 4-, 12-week intervention.
Title
Changes in concentration of immune cytokines.
Description
Changes in concentration of immune cytokines were assessed before and after 4-, 12-week intervention.
Time Frame
Before and after 4-, 12-week intervention.
Title
Changes in scores of modified medical research council (mMRC).
Description
Changes in scores of mMRC were assessed before and after 4-, 12-week intervention. The minimum score is 0 and the maximum score is 4. A higher score means more difficult breathing.
Time Frame
Before and after 4-, 12-week intervention.
Title
Changes in scores of COPD assessment test (CAT).
Description
Changes in scores of CAT were assessed before and after 4-, 12-week intervention. The minimum score is 0 and the maximum score is 40. A higher score means more seriously affect life.
Time Frame
Before and after 4-, 12-week intervention.
Title
Changes of the composition in gut microbiota.
Description
Changes of the composition in gut microbiota were analyzed by next-generation sequencing (NGS) before and after 12-week intervention.
Time Frame
Before and after 12-week intervention.
Title
Changes of the composition in lower respiratory tract microbiota.
Description
Changes of the composition in lower respiratory tract microbiota were analyzed by next-generation sequencing (NGS) before and after 12-week intervention.
Time Frame
Before and after 12-week intervention.
Title
Changes of concentration in short-chain fatty acid (SCFA) on plasma.
Description
Changes of concentration in SCFA on plasma were analyzed by gas chromatography-mass spectrometry before and after 12-week intervention.
Time Frame
Before and after 12-week intervention.
Title
Changes of concentration in short-chain fatty acid (SCFA) on stool.
Description
Changes of concentration in SCFA on stool were analyzed by gas chromatography-mass spectrometry before and after 12-week intervention.
Time Frame
Before and after 12-week intervention.
Title
Changes in scores of modified Bristol stool form scale.
Description
Changes in scores of modified Bristol stool form scale were assessed before and after 4-, 12-week intervention. The questionnaire included the stool form [1 = very hard (small hard lumps), 2 = hard stool (hard sausage shape), 3 = normal stool (sausage to banana shape), 4 = soft stool, 5 = muddy stool, 6 = watery stool], ease of defecation (1 = difficult, 2 = easy, 3 = very easy) and abdominal symptoms [frequency of upper abdominal pain, lower abdominal pain, borborygmus, and flatulence (1 = frequent, 2 = occasional, 3 = almost never)].
Time Frame
Before and after 4-, 12-week intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Feng Wei, M.D., Ph.D
Phone
886-7-6150011
Email
yufeng528@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yao-Tsung Yeh, Ph.D
Phone
886-7-7811151
Ext
6800
Email
glycosamine@yahoo.com.tw
Facility Information:
Facility Name
Glac Biotech Co., Ltd.
City
Tainan City
ZIP/Postal Code
74442
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsieh-Hsun Ho, Ph. D
Phone
886-6-5891871
Ext
6230
Email
sam.ho@glac.com.tw
First Name & Middle Initial & Last Name & Degree
Yi-Wei Kuo, Master
Phone
886-6-5891871
Ext
6231
Email
vic.kuo@glac.com.tw
First Name & Middle Initial & Last Name & Degree
Hsieh-Hsun Ho, Ph. D
12. IPD Sharing Statement
Learn more about this trial
Probiotic on Type 2 Diabetes and Chronic Obstruction Pulmonary Disease
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