Effect of a Synbiotic on Symptoms of Patients With STC
Study Details
Study Description
Brief Summary
To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria, Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Chronic constipation has become a common, often chronic, functional gastrointestinal disease which influences the quality of life all over the world. A total of 100 patients diagnosed as slow transit constipation (STC) using Rome III criteria were randomized to receive either synbiotic or placebo twice daily for 12 weeks. The primary efficacy endpoint was the clinical remission and improvement rate at week 4 and 12. Stool frequency and consistency, colonic transit time (CTT), evacuation and abdominal symptoms, Patient Assessment of Constipation Symptoms (PAC-SYM scores), Gastrointestinal Quality-of-Life Index (GIQLI), Satisfaction scores and adverse events were also monitored.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo patients allowed to take maltodextrin by the experienced doctor. |
Drug: maltodextrin
|
| Experimental: synbiotic patients are allowed to take synbiotic (BIFICOPEC) contained 0.63g bifid triple viable capsule (BIFICO) and 8g soluble dietary fiber (Pectin) . |
Drug: bifid triple viable capsule and pectin
|
Outcome Measures
Primary Outcome Measures
- Clinical remission rate [3 months]
Patients having an average of three or more spontaneous complete bowel movements (SCBMs) per week were defined as remission.
- Clinical improvement rate [3 months]
Patients with an average increase of one or more spontaneous complete bowel movements (SCBMs) per week were defined as improvement.
Secondary Outcome Measures
- Number of bowel movements per week [3 months]
- Stool consistency according to the Bristol Stool Form Scale (BSFS) [3 months]
Stool types 1 and 2 indicated constipation; types 3, 4, and 5 indicated normal; and types 6 and 7 indicated diarrhea.
- Colonic transit time (CTT) [3 months]
CTT was measured by Metcalf method.
- Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire [3 months]
The questionnaire contained 12 symptoms which were grouped into three subscales for stool, abdominal and rectal symptoms.
- The Gastrointestinal Quality-of-Life Index (GIQLI) [3 months]
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).
- Satisfaction score of constipated patients [3 months]
The score ranged from 1 (extremely unsatisfied) to 5 (extremely satisfied).
- Abdominal symptoms [3 months]
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).
- Evacuation symptoms [3 months]
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).
- Treatment-related adverse events [3 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age ≥ 18 years;
-
BMI: 18.5-25kg/m2;
-
chronic constipation was diagnosed according to RomeⅢ criteria;
-
colonic transit time (CTT) >48 hours;
-
mild-to-moderate constipation with wexner constipation scale between 16 and 25.
Exclusion Criteria:
-
megacolon, intestinal obstruction, inflammatory bowel disease, and cancer;
-
secondary constipation (i.e. drugs, endocrine disorders, neurological disorders, metabolic disorders, psychological disorders or abdominal surgery);
-
severe anterior rectocele or full thickness rectorectal intussusception according to defecography;
-
pregnant or lactating women;
-
infection with enteric pathogen;
-
usage of antibiotics or proton pump inhibitors (PPIs);
-
hepatic, renal, cardiovascular, respiratory or psychiatric disease;
-
other diseases or factors evaluated by the investigator which could influence intestinal transit or intestinal microbiota.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University | Nanjing | Jiangsu | China | 210002 |
Sponsors and Collaborators
- Jinling Hospital, China
Investigators
- Study Director: Ning Li, department of generay surgery, jinling hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BIFICOPEC-2015