Con, Con s ti, Cons ti
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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. \-
Exclusion criteria
1. Use of probiotics, prebiotics, or antibiotics within two weeks prior to enrollment and throughout the intervention period; 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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention. | 8 weeks | 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. |
Countries
China
Outcome results
None listed