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

NCT01173588 | Completed Phase 3 DMC

• 1 other identifier: PEE-001-2007
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

bowel function; functional foods

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Consistency of stools

  0, 1, 2, 3, 4, 5 weeks

• Difficulty of defecation

  0,1,2,3,4,5

• Abdominal distension

  0,1,2,3,4,5

• Flatulence

  0,1,2,3,4,5

• Abdominal pain

  0,1,2,3,4,5 weeks

Study Arms (2)

Yogurt+fiber+probiotic

EXPERIMENTAL

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)

regular yogurt

PLACEBO COMPARATOR

yogurt YR had no additional fiber or bifidobacterium

Other: yogurt added with bifidobacteria and soluble fiber (YBF)

Interventions

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

Also known as: yogurt LALA Vive, Yogurt LALA regular

Yogurt+fiber+probiotic; regular yogurt

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Lala: lead
• Cindetec: collaborator

Study Sites (1)

Cindetec

Querétaro City, Querétaro, 76230, Mexico

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Jorge JL Rosado, PhD

  UAQ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 2, 2010
• Study Start: June 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: February 1, 2008
• Last Updated: August 2, 2010

Record last verified: 2010-07

Locations

ME (1)