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.

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Other: yogurt added with bifidobacteria and soluble fiber (YBF)

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.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Queretaro, Mexico, 76230
    • Cindetec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stools Frequency	Stools frequency was reported daily as follows: 0: zero 1= once, 2= twice, 3=three times, 4= four or more times	0, 1, 2, 3, 4, 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0, 1, 2, 3, 4, 5 weeks
Difficulty of defecation	Difficulty of defecation was evaluated as 1= very easy, 2= easy, 3= hard, 4= very hard.	0,1,2,3,4,5
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.	0,1,2,3,4,5
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.	0,1,2,3,4,5
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.	0,1,2,3,4,5 weeks

Collaborators and Investigators

• Sponsor: Instituto Lala
• Collaborators: Cindetec
• Investigators: Principal Investigator: Jorge JL Rosado, PhD, UAQ

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: July 29, 2010
• First Submitted That Met QC Criteria: July 29, 2010
• First Posted (Estimate): August 2, 2010

Study Record Updates

• Last Update Posted (Estimate): August 2, 2010
• Last Update Submitted That Met QC Criteria: July 29, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: bowel function; functional foods
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: PEE-001-2007