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Effect of a Synbiotic on Symptoms of Patients With STC

J

Jinling Hospital, China

Status and phase

Completed
Phase 2

Conditions

Slow Transit Constipation

Treatments

Drug: bifid triple viable capsule and pectin
Drug: maltodextrin

Study type

Interventional

Funder types

Other

Identifiers

NCT02844426
BIFICOPEC-2015

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
patients allowed to take maltodextrin by the experienced doctor.
Treatment:
Drug: maltodextrin
synbiotic
Experimental group
Description:
patients are allowed to take synbiotic (BIFICOPEC) contained 0.63g bifid triple viable capsule (BIFICO) and 8g soluble dietary fiber (Pectin) .
Treatment:
Drug: bifid triple viable capsule and pectin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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