CompletedPhase 2

Effect of a Synbiotic on Symptoms of Patients With STC

China100 participantsStarted 2015-09

Plain-language summary

To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria, Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Clinical remission rate

Timeframe: 3 months

Clinical improvement rate

Timeframe: 3 months

Trial details

NCT IDNCT02844426

SponsorJinling Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

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