Constipation
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, immunity, 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
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Chinese adults who met the Rome III diagnostic criteria and were aged ≥20 years; 2. patients with chronic constipation (duration of more than 6 months, with less than 3 bowel movements per week and/or Bristol Scale Type 1 and 2); 3. patients in whom loose stools were rare without the use of laxatives; 4. The criteria for irritable bowel syndrome were insufficient; 5. patients that could complete the study according to the requirements of the trial protocol; 6. patients that had signed the informed consent form; 7. the study participants (including male subjects) had no fertility plans within 14 days before screening, and would voluntarily take effective contraceptive measures within 6 months after the end of the trial. Only those who met all of the above conditions could be selected. \-
Exclusion criteria
(1) Those who took items with similar functions to the test subjects in the short term, which may have affected their judgment of the results; (2) those who regularly used drugs that affect bowel habits; (3) patients who changed their diet during the study (such as regularly using a high-fiber diet, according to the recommended food score (RFS)); (4) those who were allergic to probiotics or the ingredients used in this study, those with severe immunodeficiency, or those with serious psychological or psychiatric diseases; (5) women who were pregnant, breastfeeding, or planning to become pregnant; (6) those who suffered from diseases that may cause secondary constipation, such as diabetes, thyroid disease, Alzheimer's disease, severe metabolic diseases, malignant tumors, and severe lesions of important organs (cardiovascular, lung, liver, kidney, etc.); (7) those who had used antibiotics in the two weeks prior; (8) those who did not consume the test samples as required, or were not followed up on time, resulting in uncertainty of efficacy; (9) those who had participated in another clinical trial within one month before enrollment; (10) subjects who were judged by other researchers to be unsuitable for participation. Those who met any of the above conditions were not selected. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention. | 8 weeks | Constipation symptoms are measured using Bristol Stool Form Scale (BSFS). |
Countries
China
Outcome results
None listed