B. Lactis B94 Effects of Gastrointestinal Function

August 27, 2019 updated by: University of Florida

The Effects of Bifidobacterium Animalis Ssp. Lactis B94 on Gastrointestinal Function in Adults With Prader-Willi Syndrome: A Randomized, Double-blind Study

The aim of this study is to determine the effect of daily consumption of Bifidobacterium animalis ssp lactis B94 (B. lactis B94) on stool frequency, gastrointestinal (GI) transit time, and gastrointestinal symptoms in adults with Prader-Willi syndrome. Participants (18-75 years old, n=36) will be recruited and enrolled in a 20-week randomized, placebo-controlled, crossover study. Study participants will be randomized to B. lactis B94 or placebo each for a 4-week period, preceded by a 4-week baseline and followed by 4-week washouts. Participants will complete daily questionnaires about stool frequency and stool form (transit). Dietary intake will also be assessed. A total of 5 stools (one in each period) will be collected for exploratory microbiota analysis. It is hypothesized that the B. lactis B94 will increase stool frequency, decrease the percentage of slow transit stools, and improve GI symptoms

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Probiotics have been shown to improve symptoms of constipation by decreasing gastrointestinal transit time, increasing stool frequency, and normalizing stool form. A 20-week randomized, double-blinded, placebo-controlled crossover study will be carried out. Participants will complete a 4-week baseline period during which stool frequency, stool consistency (transit time), and gastrointestinal symptoms will be collected by paper questionnaire, and participants will collect a single stool. Dietary intake data (3-day) will be obtained during the baseline period. Participants will be randomized on or about day 29 and will consume Bifidobacterium animalis ssp lactis B94 (B. lactis B94) or placebo for 4 weeks, followed by a 4-week washout, 4 weeks on the alternative, and second 4-week washout. Participants will be randomized by sealed envelope method, prepared by a UF faculty member not affiliated with the study.

During the intervention and washout periods, participants will complete daily questionnaires to assess stool frequency and form (Bristol Stool Form Scale). Furthermore, they will complete Gastrointestinal Symptom Rating Scale (GSRS) at weeks 4, 8, 12, 16 and 20(± 3 days). During these same weeks (± 3 days) dietary intake data (28-day record) and stools will be collected (1 per period). Participants' height and weight will be taken at baseline, and weight during weeks 4, 8, 12, 16 and 20.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • Food Science and Human Nutrition Department, University of Florida
      • Gainesville, Florida, United States, 32606
        • ARC of Alachua County
      • Gainesville, Florida, United States, 32608
        • UF Health Pediatrics - Gerold L. Schiebler CMS Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Are willing and able to provide informed consent.
  • Have confirmed diagnosis of PWS
  • Are willing to have height and weight measured and provide demographic information (e.g. age, race, sex)
  • Are 18-75 years of age
  • Are willing to consume B. lactis B94 and placebo each for 4-week periods
  • Are willing to complete a daily questionnaire throughout the 20-week period.
  • Are willing to complete the Gastrointestinal Symptom Rating Scale (GSRS) monthly throughout the 20-week study
  • Are willing to provide information about their dietary intake for 3-days every 4 weeks
  • Are willing to provide a valid social security for study payment purposes

Exclusion Criteria:

  • Have a milk protein allergy
  • Are currently taking medications for diarrhea
  • Are currently taking probiotics supplements and do not want to discontinue prior to the start of the baseline period (i.e. those that discontinue will be included)
  • Have previously or are currently being treated for any gastrointestinal diseases such as (gastric ulcers, Crohn's, Celiac, ulcerative colitis, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Probiotic
Bifidobacterium animalis ssp. lactis B94 at 15 billion CFUs per capsule
Dietary supplement: B. lactis B94
A probiotic dose of 15 billion per capsule.
Other Names:
  • Bifidobacterium animalis ssp lactis B94
PLACEBO_COMPARATOR: Placebo
Placebo veggie capsule.
Dietary supplement: Placebo
Placebo capsule
Other Names:
  • Placebo capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stool frequency
Time Frame: 4 weeks
Weekly stool frequency - difference between treatments
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stool frequency percentage change
Time Frame: 4 weeks
Weekly stool frequency: percentage change from baseline
4 weeks
Bristol Stool Form
Time Frame: 4 weeks
Percentage slow transit (Bristol Stool Form Scale 1 and 2)
4 weeks
Gastrointestinal symptoms
Time Frame: 4 weeks
Decrease in syndromes of Gastrointestinal Symptom Rating Scale (GSRS)
4 weeks
Compliance
Time Frame: 4 weeks
>80% of supplement intake
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lallemand Health Solutions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201701976

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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