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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| L. salivarius AP-32 and L. reuteri GL-104 | Experimental |
| |
| L. reuteri GL-104 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Subjects take one pack containing maltodextrin twice daily after breakfast and dinner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in concentration of fasting blood sugar. | Changes in concentration of fasting blood sugar were assessed before and after 4-, 12-week intervention. | Before and after 4-, 12-week intervention. |
| Changes in concentration of immune cytokines. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glac Biotech Co., Ltd. | Tainan | 74442 | Taiwan |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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. reuteri GL-104 | Dietary Supplement | Subjects take one pack containing L. reuteri GL-104 twice daily after breakfast and dinner. |
|
Changes in concentration of immune cytokines were assessed before and after 4-, 12-week intervention.
| 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. | Before and after 4-, 12-week intervention. |
| 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. | Before and after 4-, 12-week intervention. |
| 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. | 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. | 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. | 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. | 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)]. | Before and after 4-, 12-week intervention. |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |