Slow Transit Constipation Clinical Trial
Official title:
Effect of a Synbiotic on Symptoms of Patients With Slow Transit Constipation: A Prospective Randomized Trial
Verified date | September 2016 |
Source | Jinling Hospital, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria, Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. age = 18 years; 2. BMI: 18.5-25kg/m2; 3. chronic constipation was diagnosed according to Rome? criteria; 4. colonic transit time (CTT) >48 hours; 5. mild-to-moderate constipation with wexner constipation scale between 16 and 25. Exclusion Criteria: 1. megacolon, intestinal obstruction, inflammatory bowel disease, and cancer; 2. secondary constipation (i.e. drugs, endocrine disorders, neurological disorders, metabolic disorders, psychological disorders or abdominal surgery); 3. severe anterior rectocele or full thickness rectorectal intussusception according to defecography; 4. pregnant or lactating women; 5. infection with enteric pathogen; 6. usage of antibiotics or proton pump inhibitors (PPIs); 7. hepatic, renal, cardiovascular, respiratory or psychiatric disease; 8. other diseases or factors evaluated by the investigator which could influence intestinal transit or intestinal microbiota. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Jinling Hospital, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical remission rate | Patients having an average of three or more spontaneous complete bowel movements (SCBMs) per week were defined as remission. | 3 months | No |
Primary | Clinical improvement rate | Patients with an average increase of one or more spontaneous complete bowel movements (SCBMs) per week were defined as improvement. | 3 months | No |
Secondary | Number of bowel movements per week | 3 months | No | |
Secondary | Stool consistency according to the Bristol Stool Form Scale (BSFS) | Stool types 1 and 2 indicated constipation; types 3, 4, and 5 indicated normal; and types 6 and 7 indicated diarrhea. | 3 months | No |
Secondary | Colonic transit time (CTT) | CTT was measured by Metcalf method. | 3 months | No |
Secondary | Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire | The questionnaire contained 12 symptoms which were grouped into three subscales for stool, abdominal and rectal symptoms. | 3 months | No |
Secondary | The Gastrointestinal Quality-of-Life Index (GIQLI) | To evaluate specific quality of life in patients with gastrointestinal diseases, comprised 36 questions using a 5-point Likert-type scale ranging from 0 to 4 (0, worst; 4, best). | 3 months | No |
Secondary | Satisfaction score of constipated patients | The score ranged from 1 (extremely unsatisfied) to 5 (extremely satisfied). | 3 months | No |
Secondary | Abdominal symptoms | Patients recorded their symptoms of abdominal pain or cramps and bloating or flatulence according to five classifications of symptoms (1, none; 2, mild; 3, moderate; 4, severe; 5, very severe). | 3 months | No |
Secondary | Evacuation symptoms | Patients recorded their perception of straining, lumpy hard stools, sensation of incomplete evacuation, and sensation of anorectal blockage according to a 5-point ordinal scale (1, none; 2, mild; 3, moderate; 4, severe; 5, very severe). | 3 months | No |
Secondary | Treatment-related adverse events | 3 months | Yes |
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