Effect of a Synbiotic on Symptoms of Patients With STC

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

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

Study Overview

• Status: Completed
• Conditions: Slow Transit Constipation
• Intervention / Treatment: Drug: maltodextrin; Drug: bifid triple viable capsule and pectin

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: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission rate	Patients having an average of three or more spontaneous complete bowel movements (SCBMs) per week were defined as remission.	3 months
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-related adverse events		3 months
Number of bowel movements per week		3 months
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
Colonic transit time (CTT)	CTT was measured by Metcalf method.	3 months
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
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
Satisfaction score of constipated patients	The score ranged from 1 (extremely unsatisfied) to 5 (extremely satisfied).	3 months
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
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

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Investigators: Study Director: Ning Li, Department of Generay Surgery, Jinling hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: July 21, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Estimate): September 30, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: synbiotic; microbiota; soluble dietary fiber; slow transit constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: BIFICOPEC-2015