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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01173588
Enrollment
174
Registered
2010-08-02
Start date
2007-06-30
Completion date
2008-02-29
Last updated
2010-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

Keywords

bowel function, functional foods

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.

Interventions

OTHERyogurt 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

Sponsors

Cindetec
CollaboratorOTHER
Instituto Lala
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Stools Frequency0, 1, 2, 3, 4, 5 weeksStools frequency was reported daily as follows: 0: zero 1= once, 2= twice, 3=three times, 4= four or more times

Secondary

MeasureTime frameDescription
Consistency of stools0, 1, 2, 3, 4, 5 weeksConsistency 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.
Difficulty of defecation0,1,2,3,4,5Difficulty of defecation was evaluated as 1= very easy, 2= easy, 3= hard, 4= very hard.
Abdominal distension0,1,2,3,4,5Abdominal 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.
Flatulence0,1,2,3,4,5Flatulence 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.
Abdominal pain0,1,2,3,4,5 weeksAbdominal 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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026