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Effect of a Synbiotic on Symptoms of Patients With STC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02844426
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Jianfeng Gong, Jinling Hospital, China

Tracking Information
First Submitted Date  ICMJE July 20, 2016
First Posted Date  ICMJE July 26, 2016
Last Update Posted Date September 30, 2016
Study Start Date  ICMJE September 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
  • Number of bowel movements per week [ Time Frame: 3 months ]
  • 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.
  • Colonic transit time (CTT) [ Time Frame: 3 months ]
    CTT was measured by Metcalf method.
  • 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.
  • 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).
  • Satisfaction score of constipated patients [ Time Frame: 3 months ]
    The score ranged from 1 (extremely unsatisfied) to 5 (extremely satisfied).
  • 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).
  • 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).
  • Treatment-related adverse events [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Synbiotic on Symptoms of Patients With STC
Official Title  ICMJE Effect of a Synbiotic on Symptoms of Patients With Slow Transit Constipation: A Prospective Randomized Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Slow Transit Constipation
Intervention  ICMJE
  • Drug: bifid triple viable capsule and pectin
  • Drug: maltodextrin
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    patients allowed to take maltodextrin by the experienced doctor.
    Intervention: Drug: maltodextrin
  • Experimental: synbiotic
    patients are allowed to take synbiotic (BIFICOPEC) contained 0.63g bifid triple viable capsule (BIFICO) and 8g soluble dietary fiber (Pectin) .
    Intervention: Drug: bifid triple viable capsule and pectin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02844426
Other Study ID Numbers  ICMJE BIFICOPEC-2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jianfeng Gong, Jinling Hospital, China
Study Sponsor  ICMJE Jinling Hospital, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ning Li department of generay surgery, jinling hospital
PRS Account Jinling Hospital, China
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP