Effect of a Synbiotic on Symptoms of Patients With STC

Phase 2

Completed

• Conditions: Slow Transit Constipation
• Interventions: Drug: bifid triple viable capsule and pectin; Drug: maltodextrin

• Registration Number: NCT02844426
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-09
• Primary Completion: 2016-06
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-26
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
synbiotic	bifid triple viable capsule and pectin	patients are allowed to take synbiotic (BIFICOPEC) contained 0.63g bifid triple viable capsule (BIFICO) and 8g soluble dietary fiber (Pectin) .
Placebo	maltodextrin	patients allowed to take maltodextrin by the experienced doctor.

Primary Outcome Measures

Name	Time	Method
Clinical remission rate	3 months	Patients having an average of three or more spontaneous complete bowel movements (SCBMs) per week were defined as remission.
Clinical improvement rate	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

Name	Time	Method
Treatment-related adverse events	3 months
Number of bowel movements per week	3 months
Stool consistency according to the Bristol Stool Form Scale (BSFS)	3 months	Stool types 1 and 2 indicated constipation; types 3, 4, and 5 indicated normal; and types 6 and 7 indicated diarrhea.
Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire	3 months	The questionnaire contained 12 symptoms which were grouped into three subscales for stool, abdominal and rectal symptoms.
Satisfaction score of constipated patients	3 months	The score ranged from 1 (extremely unsatisfied) to 5 (extremely satisfied).
Colonic transit time (CTT)	3 months	CTT was measured by Metcalf method.
Evacuation symptoms	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).
The Gastrointestinal Quality-of-Life Index (GIQLI)	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).
Abdominal symptoms	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).

Trial Locations

Locations (1)

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China