Functional constipation
Conditions
Interventions
Bacillus coagulans BC01 group:5 billion of Bacillus coagulans BC01
Placebo group:Placebo
Sponsors
The First People's Hospital of Kunshan
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 65 years; 2. The symptom of patients met the standards of functional constipation described in Rome IV criteria(symptoms present at least 6 months prior to diagnosis, and met the standard condition during recent 3 months): (1) Must include two or more of the following: 1) Straining during more than 25% of defecations; 2) Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than 25% of defecations; 3) Sensation of incomplete evacuation more than 25% of defecations; 4) Sensation of anorectal obstruction/blockage more than 25% of defecations; 5) Manual maneuvers to facilitate more than 25% of defecations (such as digital evacuation, support of the pelvic floor); 6) Fewer than three SBM per week; (2) Loose stools are rarely present without the use of laxatives; (3) Insufficient criteria for irritable bowel syndrome; 3. Patients with good compliance and able to comply with the instructions of the clinical trial; 4. Patients or their guardians have signed the informed consent, basic information questionnaire, dietary structure and living status questionnaire, and promise to cooperate with the study throughout the study period.
Exclusion criteria
Exclusion criteria: 1. Patients with following gastrointestinal diseases that may influence the gut transit: (1) Excision of the stomach, small intestine, colon or rectum; (2) History of colon or rectal cancer; (3) History of inflammatory bowel diseases; (4) Insulin dependent diabetes mellitus; (5) Patients suffering from poorly controlled hyperthyroidism or hypothyroidism; (6) History of congenital megacolon, and diseases such as scleroderma, anorexia nervosa; (7) Other diseases or conditions that researchers believe may significantly affect colonic transit; 2. Patients with severe cardiovascular, respiratory, liver and kidney, gastrointestinal, blood, nervous system diseases; 3. During the trial, drugs affecting gastrointestinal motor function, such as motility agents, laxatives, antidiarrheal, etc., could not be stopped; 4. Pregnant or lactating women; 5. Women of childbearing age who are currently not using effective contraceptive measures; 6. Patients who cannot understand or are unwilling to fill in the diary card according to the protocol; 7. History of taking bismuth agents or antibiotics 14 days before the trial; 8. Taking other drugs such as bismuth agent, antibiotics, etc., during medication; 9. Patients have received medication relevant to constipation during the previous one week (e.g., Kexalu, phenolphthalein tablets, Japanese small powder pills, senna leaf and its extract, sesame kernel pills, Danning tablets, weight loss drugs, aloe vera and its extract, aloe vera mixture, etc), diet therapy (e.g., Probiotics, prebiotics, synbiotics, fermented milk and/or yogurt containing probiotics, herbal extracts) or other treatments such as cognitive behavioral therapy, acupuncture as well as biofeedback; 10. Patients are participating in another clinical trial or are in the exclusion phase of a previous clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete spontaneous bowel movement;Bristol Stool Scale;Gut microbiota analysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Grade of constipation concomitant symptoms (dyspepsia, anal obstruction, abdominal pain, abdominal distension); | — |
Countries
China
Contacts
Public ContactXu Yihui
The First People's Hospital of Kunshan
Outcome results
None listed