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To investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function and 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 |
|---|---|---|
| 1. Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention. | Constipation symptoms are measured using Bristol Stool Form Scale, which classifies stool into seven types (1-2 indicate constipation, 3-4 normal, and 5-7 diarrhea) for self-assessment or clinical evaluation of bowel function. | 8 weeks |
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Inclusion Criteria:
(1) Chinese adults aged 18-70 years who meet the Rome IV diagnostic criteria for chronic constipation (duration of at least 6 months, with less than three passing stools per week and/or Bristol Stool Scale types 1 and 2); (2) The patient rarely experiences diarrhea without using laxatives; (3) The criteria for irritable bowel syndrome were insufffcient ; (4) patients that could complete the study according to the requirements of the trial protocol; (5) participants (including male subjects) who have no family planning within 14 days prior to screening and voluntarily take effective contraceptive measures within 6 months after the end of the trial; (6) Patients capable of understanding the clinical study and willing to comply with the study requirements and procedures; (7) Subjects who have signed the informed consent form. Only those who meet all the above conditions can be selected for the study.
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The School of Food and Bioengineering, Henan University of Science and Technolog | Luoyang | Henan | 471000 | China |
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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. |
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| D019602 |
| Food and Beverages |