A Phase 3 interventional study of yogurt added with bifidobacteria and soluble fiber (YBF) in Inflammatory Bowel Diseases, sponsored by Instituto Lala. Completed at 1 site in Mexico. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-02.
Sponsored by Instituto Lala · Phase 3, Interventional, and Treatment
The aim of this study was to evaluate the effect of the consumption of yogurt added with bifidobacteria and soluble fiber on gastrointestinal function of healthy adults. A product as herein described is expected to improve gastrointestinal function and maintain the intestinal microflora balance of healthy subjects and perhaps of patients with altered bowel functions.
The use of probiotics and prebiotics has become popular in human nutrition and food product development. The most common probiotics are Lactobacillus and Bifidobacterium species. Bifidobacteria spp are dominant in the intestinal microflora and are considered to be beneficial to the host, for this reason research efforts have focused on increasing their proportion in the intestinal microflora through oral administration of mixtures containing bifidobacteria or oral supplementation with prebiotics. An important limitation for the effectiveness of oral probiotics is that they might be destroyed during digestion in the gastrointestinal tract therefore and adequate vehicle could improve its potential benefits. Yogurt is a suitable vehicle for the administration of bifidobacteria, due to its physicochemical properties, such as pH and nutrients content, as well as the organoleptic properties that contribute to its increasing consumption. Thus simultaneous administration of probiotics and prebiotics in a suitable vehicle could act synergistically and may have potential for improving gut health. Few clinical trials have been performed using prebiotics and probiotics. The aim of this study was to evaluate the effect of the consumption of yogurt added with bifidobacteria and soluble fiber on gastrointestinal function of healthy adults. A product as herein described is expected to improve gastrointestinal function and maintain the intestinal microflora balance of healthy subjects and perhaps of patients with altered bowel functions.
1,487 studies on the registry are indexed under Inflammatory Bowel Diseases; 434 are open to participants now.
This study's enrollment of 174 is above the median of 70 across 783 interventional studies indexed under Inflammatory Bowel Diseases.
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Exclusion Criteria:
Yogurt YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL
Other: yogurt added with bifidobacteria and soluble fiber (YBF)
yogurt YR had no additional fiber or bifidobacterium
Other: yogurt added with bifidobacteria and soluble fiber (YBF)
Yogurt in YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL
Also known as: yogurt LALA Vive, Yogurt LALA regular
Stools Frequency
Stools frequency was reported daily as follows: 0: zero 1= once, 2= twice, 3=three times, 4= four or more times
Time frame: 0, 1, 2, 3, 4, 5 weeks
Consistency of stools
Consistency of stools was scored according to the following scale: 1= watery and liquid, 2= soft and unformed, 3= soft and formed, and 4= hard and dry.
Time frame: 0, 1, 2, 3, 4, 5 weeks
Difficulty of defecation
Difficulty of defecation was evaluated as 1= very easy, 2= easy, 3= hard, 4= very hard.
Time frame: 0,1,2,3,4,5
Abdominal distension
Abdominal distension was evaluated as 1= no symptoms, 2= slight symptoms that did not influence daily activities, 3= moderate symptoms that could influence daily activities, 4= severe symptoms that affected daily activities.
Time frame: 0,1,2,3,4,5
Flatulence
Flatulence was evaluated as 1= no symptoms, 2= slight symptoms that did not influence daily activities, 3= moderate symptoms that could influence daily activities, 4= severe symptoms that affected daily activities.
Time frame: 0,1,2,3,4,5
Abdominal pain
Abdominal pain was evaluated as 1= no symptoms, 2= slight symptoms that did not influence daily activities, 3= moderate symptoms that could influence daily activities, 4= severe symptoms that affected daily activities.
Time frame: 0,1,2,3,4,5 weeks
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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