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

I

Instituto Lala

Status and phase

Completed
Phase 3

Conditions

Inflammatory Bowel Diseases

Treatments

Other: yogurt added with bifidobacteria and soluble fiber (YBF)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01173588
PEE-001-2007

Details and patient eligibility

About

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.

Full 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.

Enrollment

174 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

174 participants in 2 patient groups, including a placebo group

Yogurt+fiber+probiotic
Experimental group
Description:
Yogurt YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL
Treatment:
Other: yogurt added with bifidobacteria and soluble fiber (YBF)
regular yogurt
Placebo Comparator group
Description:
yogurt YR had no additional fiber or bifidobacterium
Treatment:
Other: yogurt added with bifidobacteria and soluble fiber (YBF)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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