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To investigate the clinical effects of probiotics in relieving intestinal motility and chronic constipation through regulating gut microbiota.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Group | Experimental | Participants receive one sachet per day containing probiotic BC99 and maltodextrin (Week 0 to Week8). |
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| Placebo Group | Placebo Comparator | Participants receive one sachet per day containing maltodextrin only, serving as the placebo(Week 0 to Week8). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | During the intervention, participants can consume BC99 daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention. | Constipation symptoms are measured using Bristol Stool Form Scale, where 1 and 2 indicate constipation with hard stools, 3 and 4 show normal conditions with ideal stool form, and 5, 6, and 7 suggest diarrhea with stools becoming softer to watery. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
(1) The use of probiotics, prebiotics, or antibiotics within 2 weeks of enrollment; (2) Regular use of a high-fiber diet, as measured by the recommended food score (RFS); (3) Regular use of medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea; (4) Currently have, or have had in the past 2 years, any gastrointestinal conditions such as: Crohn's disease, celiac disease, Ulcerative colitis, Malignant tumor of the colon; (5) Medical history of cardiovascular, liver, or renal diseases; alcoholics; (6) Hypersensitivity to probiotics or the ingredients used in this study; (7) Pregnancy or breastfeeding; (8) Participation in another clinical trial in the 3 months before enrollment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan University of Science and Technolog | Luoyang | Henan | 462000 | China |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | During the intervention, participants can consume maltodextrin daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed. |
|
| D019602 |
| Food and Beverages |