Skip to main content
OpenTrials
Completed

NCT Number: NCT02844426

Effect of a Synbiotic on Symptoms of Patients With STC

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bifid triple viable capsule and pectin

Drug

Maltodextrin

Drug

Primary outcomes

  1. Clinical remission rate

    Time frame: 3 months

    Patients having an average of three or more spontaneous complete bowel movements (SCBMs) per week were defined as remission.

  2. Clinical improvement rate

    Time frame: 3 months

    Patients with an average increase of one or more spontaneous complete bowel movements (SCBMs) per week were defined as improvement.

Secondary outcomes

  1. Number of bowel movements per week

    Time frame: 3 months

  2. Stool consistency according to the Bristol Stool Form Scale (BSFS)

    Time frame: 3 months

    Stool types 1 and 2 indicated constipation; types 3, 4, and 5 indicated normal; and types 6 and 7 indicated diarrhea.

  3. Colonic transit time (CTT)

    Time frame: 3 months

    CTT was measured by Metcalf method.

  4. Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire

    Time frame: 3 months

    The questionnaire contained 12 symptoms which were grouped into three subscales for stool, abdominal and rectal symptoms.

  5. The Gastrointestinal Quality-of-Life Index (GIQLI)

    Time frame: 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).

  6. Satisfaction score of constipated patients

    Time frame: 3 months

    The score ranged from 1 (extremely unsatisfied) to 5 (extremely satisfied).

  7. Abdominal symptoms

    Time frame: 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).

  8. Evacuation symptoms

    Time frame: 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).

  9. Treatment-related adverse events

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Registry information

Official study title

Effect of a Synbiotic on Symptoms of Patients With Slow Transit Constipation: A Prospective Randomized Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 26, 2016
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.