Overview

Effect of a Synbiotic on Symptoms of Patients With STC

Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria, Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jinling Hospital, China
Treatments:
Pectin
Criteria
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.