Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210002, China
NCT Number: NCT02844426
To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria, Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Nanjing, Jiangsu, 210002, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 months
Patients having an average of three or more spontaneous complete bowel movements (SCBMs) per week were defined as remission.
Time frame: 3 months
Patients with an average increase of one or more spontaneous complete bowel movements (SCBMs) per week were defined as improvement.
Time frame: 3 months
Time frame: 3 months
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
CTT was measured by Metcalf method.
Time frame: 3 months
The questionnaire contained 12 symptoms which were grouped into three subscales for stool, abdominal and rectal symptoms.
Time frame: 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).
Time frame: 3 months
The score ranged from 1 (extremely unsatisfied) to 5 (extremely satisfied).
Time frame: 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).
Time frame: 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).
Time frame: 3 months
Jinling Hospital, China
Other
Effect of a Synbiotic on Symptoms of Patients With Slow Transit Constipation: A Prospective Randomized Trial
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