Effect of a Synbiotic on Symptoms of Patients With STC

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

Detailed Description
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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.

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

Conditions
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Slow Transit Constipation

Intervention / Treatment
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* Drug: bifid triple viable capsule and pectin
* Drug: maltodextrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years; BMI: 18.5-25kg/m2; chronic constipation was diagnosed according to RomeⅢ criteria; colonic transit time (CTT) >48 hours; mild-to-moderate constipation with wexner constipation scale between 16 and 25. Exclusion Criteria: megacolon, intestinal obstruction, inflammatory bowel disease, and cancer; secondary constipation (i.e. drugs, endocrine disorders, neurological disorders, metabolic disorders, psychological disorders or abdominal surgery); severe anterior rectocele or full thickness rectorectal intussusception according to defecography; pregnant or lactating women; infection with enteric pathogen; usage of antibiotics or proton pump inhibitors (PPIs); hepatic, renal, cardiovascular, respiratory or psychiatric disease; other diseases or factors evaluated by the investigator which could influence intestinal transit or intestinal microbiota.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>patients allowed to take maltodextrin by the experienced doctor. | Drug: maltodextrin<br> <br> |
| Experimental: synbiotic<br>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<br> <br> |

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| Treatment-related adverse events |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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synbiotic, soluble dietary fiber, slow transit constipation, microbiota