Slow Transit Constipation
Conditions
Keywords
synbiotic, soluble dietary fiber, slow transit constipation, microbiota
Brief summary
To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria, Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.
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.
Interventions
DRUGbifid triple viable capsule and pectin
DRUGmaltodextrin
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥ 18 years; 2. BMI: 18.5-25kg/m2; 3. chronic constipation was diagnosed according to RomeⅢ 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Number of bowel movements per week | 3 months | — |
| 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 | — |
| Satisfaction score of constipated patients | 3 months | The score ranged from 1 (extremely unsatisfied) to 5 (extremely satisfied). |
| 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. |
Countries
China
Outcome results
None listed