NCT03277157

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

December 8, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

September 7, 2017

Last Update Submit

August 27, 2019

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Stool frequency

    Weekly stool frequency - difference between treatments

    4 weeks

Secondary Outcomes (4)

  • Stool frequency percentage change

    4 weeks

  • Bristol Stool Form

    4 weeks

  • Gastrointestinal symptoms

    4 weeks

  • Compliance

    4 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Bifidobacterium animalis ssp. lactis B94 at 15 billion CFUs per capsule

Dietary Supplement: B. lactis B94

Placebo

PLACEBO COMPARATOR

Placebo veggie capsule.

Dietary Supplement: Placebo

Interventions

B. lactis B94DIETARY_SUPPLEMENT

A probiotic dose of 15 billion per capsule.

Also known as: Bifidobacterium animalis ssp lactis B94
Probiotic
PlaceboDIETARY_SUPPLEMENT

Placebo capsule

Also known as: Placebo capsule
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

ARC of Alachua County

Gainesville, Florida, 32606, United States

Location

UF Health Pediatrics - Gerold L. Schiebler CMS Center

Gainesville, Florida, 32608, United States

Location

Food Science and Human Nutrition Department, University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

  • 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.

    PMID: 29703235DERIVED

Study Officials

  • Wendy J Dahl, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The B. lactis and placebo will be provided in identical capsules.
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 8, 2017

Study Start

December 8, 2017

Primary Completion

October 31, 2018

Study Completion

July 17, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

US(3)