functional constipation
Conditions
Interventions
Treatment group:Bifid.Triple Viable Capsules Dissolving at Intestines
Control group:Placebo
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Provide colonoscopy examination reports within 3 years. Otherwise, a colonoscopy must be conducted (up to the ileocecal region and with the Boston endoscopic score >= 6 points), with the results showed normal or the investigator determined that the results is mild abnormality and cannot explain the constipation symptoms of the subjects. In addition, subjects can be enrolled if they had intestinal polyps but the diameter of the polyps is <= 5mm or the researchers assessed the polyp condition as not requiring treatment immediately, or they had undergone intestinal polyp removal and had no bleeding symptoms at least one month after the procedure. 2.satisfied the Rome IV criteria for functional constipation over the past three months, with symptom onset within the last six months, i.e., experiencing two or more of the following symptoms: (1) straining during at least 25% of all defecations; (2) lumpy or hard stool in at least 25% of defecations (refer to type 1–2 assessed using the Bristol Stool Form Scale); (3) sensation of incomplete evacuation for at least 25% of defecations; (4) sensation of anorectal obstructions/blockage for at least 25% of defecations; (5) at least 25% of defecation, defecation required manual assistance (e.g., finger assistance or pelvic floor support); (6) spontaneous defecation occurred less than three times per week. And subjects rarely had loose stools without the use of laxatives, and did not meet the Rome IV criteria for irritable bowel syndrome; 3.Completed the daily electronic diary at least 6 days a week within the two-week screening period; 4.aged 18–60 years; 5.signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.allergy to any of the ingredients in the intervention material; 2.pregnancy or lactation; 3.treatment with antibiotics or probiotics within the last two weeks; 4.treatment with any laxatives, suppositories or enemas other than the remedial medication within the last two weeks, or unable to defecate for more than 72 consecutive hours, or had used remedial medications within the last two weeks; 5.experienced significant changes in diet or exercise within the past month; 6.exhibited alarm symptoms that were unexplainable and clinically significant, such as gastrointestinal bleeding, anemia, weight loss, systemic infection signs, or colitis, etc; 7.suffering from constipation due to secondary causes (such as multiple sclerosis, Parkinson's disease, spinal cord injury, etc.) or the use of opioid drugs; 8.had abnormal gastrointestinal structures or were suffering from diseases that might affect gastrointestinal motility or defecation (including inflammatory bowel disease, megacolon, pseudo-obstruction, colonic insufficiency, intestinal obstruction, perineal descent syndrome, isolated rectal ulcer syndrome, etc.); 9.had a history of chronic diseases accompanied by abdominal pain or discomfort (such as chronic pancreatitis, polycystic kidney disease, ovarian cysts, endometriosis, lactose intolerance, etc.); 10.suffering from an active case of peptic ulcer; 11.had undergone or plan to experience any of the following standard surgeries during the study, including weight loss surgery, gastrointestinal resection, appendectomy, cholecystectomy, abdominal, pelvic or retroperitoneal structure surgeries, or any other major surgery; 12.had a history of fecal impaction requiring hospitalization or emergency room treatment before and during the screening period, or had a history of laxative or enema abuse, ischemic colitis, or pelvic floor dysfunction; 13.has a history of cancer, excluding any treated cases of skin basal cell carcinoma or squamous cell carcinoma; 14.had hypothyroidism or other severe metabolic disorders, and the researchers judged that they were not suitable to participate; 15.diagnosed with active hepatitis B virus infection, hepatitis C virus infection, or positive HIV antibody within the last two weeks; 16.had severe cardiovascular or cerebrovascular diseases or autoimmune disorders, and the researchers determined that unsuitable to participate; 17.had severe functional impairments in the heart, lungs or other vital organs, and the researchers determined that unsuitable to participate; 18.experienced significant abnormalities through physical examination, electrocardiogram or laboratory tests, and the researchers determined that unsuitable to participate; 19.using of prohibited drugs, restrictions on medication or treatment before randomization; 20.had been hospitalized or attempted suicide for mental illness within the previous 2 years prior the screening visit; 21.had participated other clinical trials or used the investigational drugs within the past one month; 22.Other conditions that researchers determined that unsuitable to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The weekly mean CSBMs; | — |
Secondary
| Measure | Time frame |
|---|---|
| The weekly mean SBMs;Mean weekly stool consistency score;Mean weekly stool straining score;The time from taking the research drug to the first occurrence of SBM and CSBM;The percentage of subjects who experienced SBM and CSBM within the first 24 hours of treatment;The use of remedial drugs;Patient Assessment of Constipation Quality of Life (PAC-QOL);Depression Anxiety and Stress Scale, DASS-21;Gut microbiota analysis;Fecal metabolomics analysis;Adverse events and laboratory examination; | — |
Countries
China
Contacts
Public ContactZhu Yin
The First Affiliated Hospital of Nanchang University
Outcome results
None listed