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This study intends to evaluate the effects of three prebiotic solid beverages (mainly dietary fiber and prebiotics) and one probiotic solid beverage on the laxative effect of patients with functional constipation through randomized controlled trials. The influence of tract flora is expected to provide a basis for related therapies for patients with functional constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | a mixture of Xylooligosaccharides, Stachyose, Fructooligosaccharides, and Water-soluble Dietary Fiber, 12 g/d, 4 weeks |
|
| Group B | Experimental | a mixture of Fructooligosaccharide, water-soluble dietary fiber, polydextrose, and isomalt oligosaccharide, 12 g/d, 4 weeks |
|
| Group C | Experimental | a mixture of Polydextrose, wheat fiber, and Seed shell of Plantago rotundifolia, 12 g/d, 4 weeks |
|
| Group D | Experimental | a mixture of Fructooligosaccharides, Bifidobacterium lactis HN019 and Lactobacillus rhamnosus HN001, 3 g/d, 4 weeks |
|
| Group E | Placebo Comparator | Maltodextrin, 3 g/d, 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotics or Probiotics | Dietary Supplement | All the supplements were provided in solid drinks,and required to drink with plain water 35-40℃, and lifestyle intervention was provided to all the groups by reading materials. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of bowel movements per week | bowel movements will be recorded per week | week 0 to 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Classification of bowel status | Classification according to the difficulty of defecation 9/5000 According to the difficulty of defecation | day 0, 14, 28 |
| Bristol classification of stool characteristics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xin Liu | Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37078654 | Derived | Lai H, Li Y, He Y, Chen F, Mi B, Li J, Xie J, Ma G, Yang J, Xu K, Liao X, Yin Y, Liang J, Kong L, Wang X, Li Z, Shen Y, Dang S, Zhang L, Wu Q, Zeng L, Shi L, Zhang X, Tian T, Liu X. Effects of dietary fibers or probiotics on functional constipation symptoms and roles of gut microbiota: a double-blinded randomized placebo trial. Gut Microbes. 2023 Jan-Dec;15(1):2197837. doi: 10.1080/19490976.2023.2197837. |
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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 |
|---|---|
| D056692 | Prebiotics |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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Bristol classification
| day 0, 14, 28 |
| glucose | Fasting plasma | day 0, 14, 28 |
| HDL-C | Fasting plasma | day 0, 14, 28 |
| LDL-C | Fasting plasma | day 0, 14, 28 |
| TG | Fasting plasma | day 0, 14, 28 |
| Tch | Fasting plasma | day 0, 14, 28 |
| diversity and abundance of intestinal flora | 16s rRNA | day 0, 14, 28 |
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |