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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173588
• Other study ID #: PEE-001-2007
• Status: Completed
• Phase: Phase 3
• First received: July 29, 2010
• Last updated: July 29, 2010
• Start date: June 2007
• Est. completion date: February 2008

Study information

• Verified date: July 2010
• Source: Instituto Lala
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: February 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Intervention

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

Locations

Country	Name	City	State
Mexico	Cindetec	Queretaro

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Lala	Cindetec

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes