Clinical trial NCT01173588: Effect of Yogurt Added With Bifidobacteria and Soluble Fiber on Bowel Function.
Official title: Effect of Yogurt Added With Bifidobacteria and Soluble Fiber on Bowel Function: A Randomized, Double-blind, Longitudinal Controlled Study in Mexican Adult.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammatory Bowel Diseases
Keywords: bowel function
functional foods
Lead sponsor: Instituto Lala
Sponsor class: INDUSTRY
Collaborators: name: Cindetec
First posted: 2010-08-02
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stools Frequency
timeFrame: 0, 1, 2, 3, 4, 5 weeks
Secondary outcomes:
measure: Consistency of stools
timeFrame: 0, 1, 2, 3, 4, 5 weeks
measure: Difficulty of defecation
timeFrame: 0,1,2,3,4,5
measure: Abdominal distension
timeFrame: 0,1,2,3,4,5
measure: Flatulence
timeFrame: 0,1,2,3,4,5
measure: Abdominal pain
timeFrame: 0,1,2,3,4,5 weeks
Other outcomes:
Locations:
city: Queretaro
country: Mexico
facility: Cindetec
Study officials:
affiliation: UAQ
name: Jorge JL Rosado, PhD
role: PRINCIPAL_INVESTIGATOR
References: