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B. Lactis B94 Effects of Gastrointestinal Function

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ClinicalTrials.gov Identifier: NCT03277157
Recruitment Status : Active, not recruiting
First Posted : September 8, 2017
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
Lallemand Health Solutions
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE September 7, 2017
First Posted Date  ICMJE September 8, 2017
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE December 8, 2017
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
Stool frequency [ Time Frame: 4 weeks ]
Weekly stool frequency - difference between treatments
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03277157 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
  • Stool frequency percentage change [ Time Frame: 4 weeks ]
    Weekly stool frequency: percentage change from baseline
  • Bristol Stool Form [ Time Frame: 4 weeks ]
    Percentage slow transit (Bristol Stool Form Scale 1 and 2)
  • Gastrointestinal symptoms [ Time Frame: 4 weeks ]
    Decrease in syndromes of Gastrointestinal Symptom Rating Scale (GSRS)
  • Compliance [ Time Frame: 4 weeks ]
    >80% of supplement intake
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE B. Lactis B94 Effects of Gastrointestinal Function
Official Title  ICMJE The Effects of Bifidobacterium Animalis Ssp. Lactis B94 on Gastrointestinal Function in Adults With Prader-Willi Syndrome: A Randomized, Double-blind Study
Brief Summary 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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The B. lactis and placebo will be provided in identical capsules.
Primary Purpose: Other
Condition  ICMJE Quality of Life
Intervention  ICMJE
  • Dietary Supplement: B. lactis B94
    A probiotic dose of 15 billion per capsule.
    Other Name: Bifidobacterium animalis ssp lactis B94
  • Dietary Supplement: Placebo
    Placebo capsule
    Other Name: Placebo capsule
Study Arms  ICMJE
  • Experimental: Probiotic
    Bifidobacterium animalis ssp. lactis B94 at 15 billion CFUs per capsule
    Intervention: Dietary Supplement: B. lactis B94
  • Placebo Comparator: Placebo
    Placebo veggie capsule.
    Intervention: Dietary Supplement: Placebo
Publications * Alyousif Z, Miller JL, Sandoval MY, MacPherson CW, Nagulesapillai V, Dahl WJ. The effects of Bifidobacterium animalis ssp. lactis B94 on gastrointestinal wellness in adults with Prader-Willi syndrome: study protocol for a randomized controlled trial. Trials. 2018 Apr 27;19(1):256. doi: 10.1186/s13063-018-2648-x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 16, 2018)
28
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2017)
36
Estimated Study Completion Date  ICMJE August 31, 2019
Actual Primary Completion Date October 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03277157
Other Study ID Numbers  ICMJE IRB201701976
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Lallemand Health Solutions
Investigators  ICMJE
Principal Investigator: Wendy J Dahl, PhD University of Florida
PRS Account University of Florida
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP