Effect of a Synbiotic on Symptoms of Patients With STC
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|ClinicalTrials.gov Identifier: NCT02844426|
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : September 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Slow Transit Constipation||Drug: bifid triple viable capsule and pectin Drug: maltodextrin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of a Synbiotic on Symptoms of Patients With Slow Transit Constipation: A Prospective Randomized Trial|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||September 2016|
Placebo Comparator: Placebo
patients allowed to take maltodextrin by the experienced doctor.
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
- Clinical remission rate [ Time Frame: 3 months ]Patients having an average of three or more spontaneous complete bowel movements (SCBMs) per week were defined as remission.
- Clinical improvement rate [ Time Frame: 3 months ]Patients with an average increase of one or more spontaneous complete bowel movements (SCBMs) per week were defined as improvement.
- Number of bowel movements per week [ Time Frame: 3 months ]
- Stool consistency according to the Bristol Stool Form Scale (BSFS) [ 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.
- Colonic transit time (CTT) [ Time Frame: 3 months ]CTT was measured by Metcalf method.
- Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire [ Time Frame: 3 months ]The questionnaire contained 12 symptoms which were grouped into three subscales for stool, abdominal and rectal symptoms.
- The Gastrointestinal Quality-of-Life Index (GIQLI) [ 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).
- Satisfaction score of constipated patients [ Time Frame: 3 months ]The score ranged from 1 (extremely unsatisfied) to 5 (extremely satisfied).
- Abdominal symptoms [ 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).
- Evacuation symptoms [ 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).
- Treatment-related adverse events [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844426
|Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University|
|Nanjing, Jiangsu, China, 210002|
|Study Director:||Ning Li||department of generay surgery, jinling hospital|