Effect of a Synbiotic on Symptoms of Patients With STC

Slow Transit Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02844426
• Other study ID #: BIFICOPEC-2015
• Status: Completed
• Phase: Phase 2
• First received: July 20, 2016
• Last updated: September 29, 2016
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age = 18 years;

2. BMI: 18.5-25kg/m2;

3. chronic constipation was diagnosed according to Rome? 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Slow Transit Constipation

Intervention

Drug:
• bifid triple viable capsule and pectin

• maltodextrin

Locations

Country	Name	City	State
China	Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission rate	Patients having an average of three or more spontaneous complete bowel movements (SCBMs) per week were defined as remission.	3 months	No
Primary	Clinical improvement rate	Patients with an average increase of one or more spontaneous complete bowel movements (SCBMs) per week were defined as improvement.	3 months	No
Secondary	Number of bowel movements per week		3 months	No
Secondary	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.	3 months	No
Secondary	Colonic transit time (CTT)	CTT was measured by Metcalf method.	3 months	No
Secondary	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.	3 months	No
Secondary	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).	3 months	No
Secondary	Satisfaction score of constipated patients	The score ranged from 1 (extremely unsatisfied) to 5 (extremely satisfied).	3 months	No
Secondary	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).	3 months	No
Secondary	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).	3 months	No
Secondary	Treatment-related adverse events		3 months	Yes