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

This study has been completed.
Sponsor:
Collaborator:
Cindetec
Information provided by:
Instituto Lala
ClinicalTrials.gov Identifier:
NCT01173588
First received: July 29, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Inflammatory Bowel Diseases
Other: yogurt added with bifidobacteria and soluble fiber (YBF)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Yogurt Added With Bifidobacteria and Soluble Fiber on Bowel Function: A Randomized, Double-blind, Longitudinal Controlled Study in Mexican Adult.

Resource links provided by NLM:


Further study details as provided by Instituto Lala:

Primary Outcome Measures:
  • Stools Frequency [ Time Frame: 0, 1, 2, 3, 4, 5 weeks ] [ Designated as safety issue: No ]
    Stools frequency was reported daily as follows: 0: zero 1= once, 2= twice, 3=three times, 4= four or more times


Secondary Outcome Measures:
  • Consistency of stools [ Time Frame: 0, 1, 2, 3, 4, 5 weeks ] [ Designated as safety issue: No ]
    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.

  • Difficulty of defecation [ Time Frame: 0,1,2,3,4,5 ] [ Designated as safety issue: No ]
    Difficulty of defecation was evaluated as 1= very easy, 2= easy, 3= hard, 4= very hard.

  • Abdominal distension [ Time Frame: 0,1,2,3,4,5 ] [ Designated as safety issue: Yes ]
    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.

  • Flatulence [ Time Frame: 0,1,2,3,4,5 ] [ Designated as safety issue: Yes ]
    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.

  • Abdominal pain [ Time Frame: 0,1,2,3,4,5 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 174
Study Start Date: June 2007
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yogurt+fiber+probiotic
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)
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
Placebo Comparator: regular yogurt
yogurt YR had no additional fiber or bifidobacterium
Other: yogurt 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
Other Names:
  • yogurt LALA Vive
  • Yogurt LALA regular

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173588

Locations
Mexico
Cindetec
Queretaro, Mexico, 76230
Sponsors and Collaborators
Instituto Lala
Cindetec
Investigators
Principal Investigator: Jorge JL Rosado, PhD UAQ
  More Information

No publications provided

Responsible Party: Jorge Luis Rosado Loría, Universidad autonoma de queretaro
ClinicalTrials.gov Identifier: NCT01173588     History of Changes
Other Study ID Numbers: PEE-001-2007
Study First Received: July 29, 2010
Last Updated: July 29, 2010
Health Authority: Mexico: Ethics Committee

Keywords provided by Instituto Lala:
bowel function
functional foods

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 20, 2014