Effect of Yogurt Added With Bifidobacteria and Soluble Fiber on Bowel Function.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Yogurt Added With Bifidobacteria and Soluble Fiber on Bowel Function: A Randomized, Double-blind, Longitudinal Controlled Study in Mexican Adult.

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Other: yogurt added with bifidobacteria and soluble fiber (YBF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 55 years, be free of known gastrointestinal diseases, desist of consuming prebiotic and/or probiotic-containing foods or dietary supplements during the entire duration of the study, agree to avoid any medication that produced changes in gastrointestinal function, diarrhea or constipation until completion of the study, be willing to complete all necessary study questionnaires, accept voluntary participation and sign a written informed consent before inclusion in the study. Exclusion Criteria: subjects receiving any kind of treatment that may had altered bowel function; intake of laxatives, a concomitant sever gastrointestinal disease; that were consuming probiotics and/or prebiotics-containing foods or dietary supplements within the two previous weeks; subjects were also excluded if they had received any antimicrobial medication during the previous 2 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yogurt+fiber+probiotic<br>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)<br>* Yogurt in YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL<br>* Other names: Yogurt LALA regular;|
| Placebo Comparator: regular yogurt<br>yogurt YR had no additional fiber or bifidobacterium | Other: yogurt added with bifidobacteria and soluble fiber (YBF)<br>* Yogurt in YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL<br>* Other names: Yogurt LALA regular;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stools Frequency | Stools frequency was reported daily as follows: 0: zero 1= once, 2= twice, 3=three times, 4= four or more times | 0, 1, 2, 3, 4, 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 0,1,2,3,4,5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bowel function, functional foods