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Effect of a Synbiotic on Symptoms of Patients With STC

Primary Purpose

Slow Transit Constipation

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
bifid triple viable capsule and pectin
maltodextrin
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Slow Transit Constipation focused on measuring synbiotic, soluble dietary fiber, slow transit constipation, microbiota

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

synbiotic

Arm Description

patients allowed to take maltodextrin by the experienced doctor.

patients are allowed to take synbiotic (BIFICOPEC) contained 0.63g bifid triple viable capsule (BIFICO) and 8g soluble dietary fiber (Pectin) .

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of bowel movements per week
Stool consistency according to the Bristol Stool Form Scale (BSFS)
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)
CTT was measured by Metcalf method.
Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire
The questionnaire contained 12 symptoms which were grouped into three subscales for stool, abdominal and rectal symptoms.
The Gastrointestinal Quality-of-Life Index (GIQLI)
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
The score ranged from 1 (extremely unsatisfied) to 5 (extremely satisfied).
Abdominal symptoms
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
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

Full Information

First Posted
July 20, 2016
Last Updated
September 29, 2016
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02844426
Brief Title
Effect of a Synbiotic on Symptoms of Patients With STC
Official Title
Effect of a Synbiotic on Symptoms of Patients With Slow Transit Constipation: A Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Slow Transit Constipation
Keywords
synbiotic, soluble dietary fiber, slow transit constipation, microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patients allowed to take maltodextrin by the experienced doctor.
Arm Title
synbiotic
Arm Type
Experimental
Arm Description
patients are allowed to take synbiotic (BIFICOPEC) contained 0.63g bifid triple viable capsule (BIFICO) and 8g soluble dietary fiber (Pectin) .
Intervention Type
Drug
Intervention Name(s)
bifid triple viable capsule and pectin
Intervention Type
Drug
Intervention Name(s)
maltodextrin
Primary Outcome Measure Information:
Title
Clinical remission rate
Description
Patients having an average of three or more spontaneous complete bowel movements (SCBMs) per week were defined as remission.
Time Frame
3 months
Title
Clinical improvement rate
Description
Patients with an average increase of one or more spontaneous complete bowel movements (SCBMs) per week were defined as improvement.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of bowel movements per week
Time Frame
3 months
Title
Stool consistency according to the Bristol Stool Form Scale (BSFS)
Description
Stool types 1 and 2 indicated constipation; types 3, 4, and 5 indicated normal; and types 6 and 7 indicated diarrhea.
Time Frame
3 months
Title
Colonic transit time (CTT)
Description
CTT was measured by Metcalf method.
Time Frame
3 months
Title
Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire
Description
The questionnaire contained 12 symptoms which were grouped into three subscales for stool, abdominal and rectal symptoms.
Time Frame
3 months
Title
The Gastrointestinal Quality-of-Life Index (GIQLI)
Description
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).
Time Frame
3 months
Title
Satisfaction score of constipated patients
Description
The score ranged from 1 (extremely unsatisfied) to 5 (extremely satisfied).
Time Frame
3 months
Title
Abdominal symptoms
Description
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).
Time Frame
3 months
Title
Evacuation symptoms
Description
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).
Time Frame
3 months
Title
Treatment-related adverse events
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ning Li
Organizational Affiliation
department of generay surgery, jinling hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

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Effect of a Synbiotic on Symptoms of Patients With STC

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