Skip to main content
OpenTrials
Completed

NCT Number: NCT01173588

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cindetec

Querétaro City, Querétaro, 76230, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

yogurt added with bifidobacteria and soluble fiber (YBF)

Other

Yogurt in YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL

Other names: yogurt LALA Vive, Yogurt LALA regular

Primary outcomes

  1. Stools Frequency

    Time frame: 0, 1, 2, 3, 4, 5 weeks

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

Secondary outcomes

  1. Consistency of stools

    Time frame: 0, 1, 2, 3, 4, 5 weeks

    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.

  2. Difficulty of defecation

    Time frame: 0,1,2,3,4,5

    Difficulty of defecation was evaluated as 1= very easy, 2= easy, 3= hard, 4= very hard.

  3. Abdominal distension

    Time frame: 0,1,2,3,4,5

    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.

  4. Flatulence

    Time frame: 0,1,2,3,4,5

    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.

  5. Abdominal pain

    Time frame: 0,1,2,3,4,5 weeks

    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.

Sponsors and collaborators

Lead sponsor

Instituto Lala

Industry

Collaborators

  • Cindetec

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Aug 2, 2010
Registry last updated
Aug 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.