Gastrointestinal discomfort regularly affects \>25% of the population worldwide. One of the major contributors to Gastrointestinal discomfort is constipation, which has a prevalence of \~15%, and symptoms of which have a significant negative impact on the sufferer's quality of life. One of the hallmarks of chronic constipation is slow progression of contents through the gut (i.e. slow gut / colonic transit time), which may be associated with hard stools that are difficult to expel. Previous studies have shown that probiotics improve colonic transit times in constipated patients. In addition, several other studies, employing a range of different probiotic strains, have shown a significant increase in defaecation frequency and improvement in stool consistency. However, the clinical relevance of these results is uncertain, due to small sample sizes and limitations in study methodology. The current study is designed to compare changes in gut transit time and gastrointestinal symptoms following 4 weeks consumption of a probiotic strain in a randomized, double-blind, placebo-controlled manner, in adults with constipation.
This is an adaptive, parallel, double-blinded, randomized, placebo-controlled, stratified clinical study, comparing three study arms (two quantities of the probiotic active component and one placebo)with equal allocation ratio. Recruitment of subjects to the low quantity of the probiotic will be after fulfilling certain criteria at interim. After half of the subjects in the two study groups of high quantity and placebo have completed the study (40 subjects), an interim analysis will be performed. Depending on the observed effect size and the conditional power, the study may be stopped for futility, continued with the two groups or continued with inclusion of the third group of low dose probiotics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Wingate Institute, Queen Mary University of London
London, United Kingdom
Whole gut transit time- 2 groups
To evaluate change in whole gut transit time 2 weeks after consumption of the study product in constipated patients consuming the study product containing probiotics in high quantity, compared to those consuming placebo
Time frame: After 2 weeks consumption of the study product
Regional colonic transit time- all groups
To evaluate change in the regional (right colon, left colon, and rectosigmoid)transit time 2 weeks after consumption of the study product in all groups
Time frame: After 2 weeks consumption of the study product
Whole gut and Regional colonic transit time- all groups
To evaluate the whole gut and regional colonic transit time after 4 weeks consumption of the study product in all study groups
Time frame: After 4 weeks consumption of the study product
Whole gut transit time- all groups
To evaluate change in whole gut transit time 2 weeks after consumption of the study product in all groups
Time frame: After 2 weeks consumption of the study product
Response to the Patient assessment of constipation symptoms (PAC-SYM) - all groups
To evaluate change in Gastrointestinal symptoms 2\&4 weeks after consumption of the study product in all groups
Time frame: After 2&4 weeks consumption of the study product
Cleveland Clinic constipation score - all groups
To evaluate change in Gastrointestinal symptoms 2\&4 weeks after consumption of the study product in all groups
Time frame: After 1&2&4 weeks consumption of the study product
Stool frequency- all groups
Assessed through daily bowel diary records for each bowel movement
Time frame: After 2&4 weeks consumption of the study product
Stool consistency - all groups
To evaluate stool form (Bristol stool scale) 2\&4 weeks after consumption of the study product in all groups
Time frame: After 2&4 weeks consumption of the study product
Response to the constipation quality of life (PAC-QOL)questionnaires - all groups
To evaluate change in quality of life 2\&4 weeks after consumption of the study product in all groups
Time frame: After 2&4 weeks consumption of the study product
Tolerance to the study product- all groups
Response to tolerance questionnaire 2\&4 weeks after consumption of the study product in all groups
Time frame: After 2&4 weeks consumption of the study product
Global Constipation Symptom Score - all groups
To evaluate change in Gastrointestinal symptoms 2\&4 weeks after consumption of the study product in all groups
Time frame: After 1&2&4 weeks consumption of the study product
Ease of passage - all groups
Assessed through daily bowel diary records for each bowel movement
Time frame: After 2&4 weeks consumption of the study product
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