Inflammatory Bowel DiseasesPhase 3NCT01173588
Effect of Yogurt Added With Bifidobacteria and Soluble Fiber on Bowel Function.
A Phase 3 study testing yogurt added with bifidobacteria and soluble fiber (YBF) in people with Inflammatory Bowel Diseases, run by Instituto Lala at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- yogurt added with bifidobacteria and soluble fiber (YBF)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2007to Feb 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- yogurt added with bifidobacteria and soluble fiber (YBF)
- Keywords
- bowel function, functional foods
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogurt added with bifidobacteria and soluble fiber (YBF)Other
Also called yogurt LALA Vive, Yogurt LALA regular
Yogurt in YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL
| Study group | Role | What they receive |
|---|---|---|
| Yogurt+fiber+probiotic | Experimental | Yogurt YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL Receives: Other: yogurt added with bifidobacteria and soluble fiber (YBF) |
| regular yogurt | Placebo comparator | yogurt YR had no additional fiber or bifidobacterium Receives: Other: yogurt added with bifidobacteria and soluble fiber (YBF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stools Frequency
Stools frequency was reported daily as follows: 0: zero 1= once, 2= twice, 3=three times, 4= four or more times
Measured: 0, 1, 2, 3, 4, 5 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0,1,2,3,4,5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startJun 2007
- Primary completionDec 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Lala
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cindetec
- Investigators
- Jorge JL Rosado, PhD, Principal investigator, UAQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173588
- Sponsor's protocol ID
- PEE-001-2007
- Status last verified
- Jul 2010
- First submitted
- 29 Jul 2010
- Last updated
- 2 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yogurt Added With Bifidobacteria and Soluble Fiber on Bowel Function: A Randomized, Double-blind, Longitudinal Controlled Study in Mexican Adult.
- ClinicalTrials.gov ID
- NCT01173588
- Acronym / sponsor ID
- PEE-001-2007
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- bowel function, functional foods
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Instituto LalaIndustry (pharma, biotech, devices)
- Collaborators
- Cindetec
- Study start
- Jun 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 2 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yogurt+fiber+probiotic | Experimental | Other: yogurt added with bifidobacteria and soluble fiber (YBF)Yogurt YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL |
| regular yogurt | Placebo comparator | Other: yogurt added with bifidobacteria and soluble fiber (YBF)yogurt YR had no additional fiber or bifidobacterium |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| yogurt added with bifidobacteria and soluble fiber (YBF)Also: yogurt LALA Vive, Yogurt LALA regularYogurt in YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL | Other | Yogurt+fiber+probiotic, regular yogurt |
Primary outcome
Stools Frequency
Time frame: 0, 1, 2, 3, 4, 5 weeks
Stools frequency was reported daily as follows: 0: zero 1= once, 2= twice, 3=three times, 4= four or more times
5 secondary outcomes
Consistency of stools
Time frame: 0, 1, 2, 3, 4, 5 weeks
Difficulty of defecation
Time frame: 0,1,2,3,4,5
Abdominal distension
Time frame: 0,1,2,3,4,5
Flatulence
Time frame: 0,1,2,3,4,5
Abdominal pain
Time frame: 0,1,2,3,4,5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge JL Rosado, PhD principal investigator
UAQ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing yogurt added with bifidobacteria and soluble fiber (YBF) in people with Inflammatory Bowel Diseases, run by Instituto Lala at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stools Frequency (time frame: 0, 1, 2, 3, 4, 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2010.