functional constipation and diarrhea (FC/FDR)
Conditions
Interventions
Group 1:Wonderlab probiotics
Group 2:Wonderlab probiotics
Control Group 1:maltodextrin
Control Group 2:maltodextrin
Sponsors
Shenzhen Precision Health Food Technology Co.,Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, 18 to 65 years old; 2. PI recruited functional constipation subjects with BMI > 24 on the basis of Rome IV standard; 3. PI recruited subjects with functional diarrhea on the basis of Rome IV criteria; 4. During the study,the subjects agree not to take any drugs, supplements or other dairy products; 5. During the study,the subjects agree not to take any other prebiotic / bacterial drugs, supplements, or dairy products, including yogurt drinks; 6. Subjects are willing not to participate in other interventional clinical studies during the study; 7. Subjects can fully understand the nature, purpose, benefits, possible risks and side effects of the study; 8. Willing to obey all test requirements and procedures; 9. Agreed to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subject who is in the treatment of gastrointestinal diseases; 2. Subject who has lactose intolerance; 3. The subjects are currently suffering from other organic diseases that affect intestinal function, such as history of gastrointestinal resection, colonic or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, anorexia nervosa, etc.; 4. In the last 3 months, those who have been controlling diet, strengthening exercise, or taking drugs to control weight or affect appetite; 5. Subjects have any of the following medical histories or clinically diagnosed diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases; 6. Subejects who current or past abuse of alcohol or other prohibited drugs, supplements or OTC prescription drugs may cause intestinal dysfunction or affect the evaluation of the study effect; 7. According to the judgment of the researchers, frequent use of drugs that may affect gastrointestinal function or the immune system; 8. Subjects who took laxatives or other digestive aids 2 weeks before the start of the study; 9. Consumed dairy products or other foods containing prebiotics/bacteria within 10 days before the start of the study; 10. Pregnant or breastfeeding women, or those planning to become pregnant during the study; 11. PI believes that volunteers cannot fully cooperate with the trial arrangement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IL-4;IL-8;IL-10;IFN-?;hsCRP;IgA;IgG;IgM;MTL;sIgA;16sRNA sequencing;SCFA;Height, Weight, BMI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Waist;Hip;Fat percentage;72-hour diet review;Weekly exercise review; | — |
Countries
China
Contacts
Public ContactXu Leiming
Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed