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Effect of a Synbiotic on Symptoms of Patients With STC

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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

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

Condition or disease Intervention/treatment Phase
Slow Transit Constipation Drug: bifid triple viable capsule and pectin Drug: maltodextrin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of a Synbiotic on Symptoms of Patients With Slow Transit Constipation: A Prospective Randomized Trial
Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Placebo Comparator: Placebo
patients allowed to take maltodextrin by the experienced doctor.
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) .
Drug: bifid triple viable capsule and pectin



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844426


Locations
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China, Jiangsu
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Jinling Hospital, China
Investigators
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Study Director: Ning Li department of generay surgery, jinling hospital
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Responsible Party: Jianfeng Gong, Professor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02844426    
Other Study ID Numbers: BIFICOPEC-2015
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Keywords provided by Jianfeng Gong, Jinling Hospital, China:
synbiotic
soluble dietary fiber
slow transit constipation
microbiota
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive