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

Primary Purpose

Inflammatory Bowel Diseases

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
yogurt added with bifidobacteria and soluble fiber (YBF)
Sponsored by
Instituto Lala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring bowel function, functional foods

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Cindetec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Yogurt+fiber+probiotic

regular yogurt

Arm Description

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

yogurt YR had no additional fiber or bifidobacterium

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
July 29, 2010
Last Updated
July 29, 2010
Sponsor
Instituto Lala
Collaborators
Cindetec
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1. Study Identification

Unique Protocol Identification Number
NCT01173588
Brief Title
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

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Instituto Lala
Collaborators
Cindetec

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
bowel function, functional foods

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yogurt+fiber+probiotic
Arm Type
Experimental
Arm Description
Yogurt YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL
Arm Title
regular yogurt
Arm Type
Placebo Comparator
Arm Description
yogurt YR had no additional fiber or bifidobacterium
Intervention Type
Other
Intervention Name(s)
yogurt added with bifidobacteria and soluble fiber (YBF)
Other Intervention Name(s)
yogurt LALA Vive, Yogurt LALA regular
Intervention Description
Yogurt in YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL
Primary Outcome Measure Information:
Title
Stools Frequency
Description
Stools frequency was reported daily as follows: 0: zero 1= once, 2= twice, 3=three times, 4= four or more times
Time Frame
0, 1, 2, 3, 4, 5 weeks
Secondary Outcome Measure Information:
Title
Consistency of stools
Description
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.
Time Frame
0, 1, 2, 3, 4, 5 weeks
Title
Difficulty of defecation
Description
Difficulty of defecation was evaluated as 1= very easy, 2= easy, 3= hard, 4= very hard.
Time Frame
0,1,2,3,4,5
Title
Abdominal distension
Description
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.
Time Frame
0,1,2,3,4,5
Title
Flatulence
Description
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.
Time Frame
0,1,2,3,4,5
Title
Abdominal pain
Description
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.
Time Frame
0,1,2,3,4,5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge JL Rosado, PhD
Organizational Affiliation
UAQ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cindetec
City
Queretaro
ZIP/Postal Code
76230
Country
Mexico

12. IPD Sharing Statement

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

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