Effect of a Synbiotic on Symptoms of Patients With STC

Jinling Hospital, China100 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Slow Transit Constipation

Interventions

bifid triple viable capsule and pectinDRUG

maltodextrinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Clinical remission rate

Patients having an average of three or more spontaneous complete bowel movements (SCBMs) per week were defined as remission.

Time frame: 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.

Time frame: 3 months

Secondary Outcomes

Number of bowel movements per week

Time frame: 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.

Time frame: 3 months

Colonic transit time (CTT)

CTT was measured by Metcalf method.

Time frame: 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.

Time frame: 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).

Time frame: 3 months

Satisfaction score of constipated patients

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.