Clinical trial NCT02844426: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Slow Transit Constipation
Keywords: synbiotic
soluble dietary fiber
slow transit constipation
microbiota
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Clinical remission rate
timeFrame: 3 months
measure: Clinical improvement rate
timeFrame: 3 months
Secondary outcomes:
measure: Number of bowel movements per week
timeFrame: 3 months
measure: Stool consistency according to the Bristol Stool Form Scale (BSFS)
timeFrame: 3 months
measure: Colonic transit time (CTT)
timeFrame: 3 months
measure: Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire
timeFrame: 3 months
measure: The Gastrointestinal Quality-of-Life Index (GIQLI)
timeFrame: 3 months
measure: Satisfaction score of constipated patients
timeFrame: 3 months
measure: Abdominal symptoms
timeFrame: 3 months
measure: Evacuation symptoms
timeFrame: 3 months
measure: Treatment-related adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: department of generay surgery, jinling hospital
name: Ning Li
role: STUDY_DIRECTOR
References: