NCT01203462

Brief Summary

The purpose of this study is to determine the effect of probiotic supplemented yogurt in reducing colonic transit time (CTT) in females between the ages of 18-65 years old. Two yogurts will be administered, one containing a specific strain of probiotic in the Bifidobacterium genus and the other without the probiotic supplement. It is hypothesized that subjects receiving the probiotic supplemented yogurt will experience reduced CTT and improved gastrointestinal comfort and quality of life compared to those receiving the non-probiotic supplemented yogurt.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

February 11, 2013

Status Verified

December 1, 2012

Enrollment Period

9 months

First QC Date

September 15, 2010

Last Update Submit

February 8, 2013

Conditions

Digestive IrregularityDigestive DiscomfortHistory of Straining During Bowel MovementsHistory of Hard or Lumpy Stools

Outcome Measures

Primary Outcomes (1)

  • Colonic Transit Time

    90 days

Secondary Outcomes (10)

  • Frequency of bowel movements (daily)

    90 days

  • Stool consistency (daily)

    90 days

  • Well being as assessed by agreed upon quality of life instrument

    90 days

  • Dietary intake survey

    90 days

  • Tolerance

    90 days

  • +5 more secondary outcomes

Study Arms (2)

Bifidobacterium supplemented yogurt

EXPERIMENTAL

Bifidobacterium supplemented (minimum dosage of 1E+10cfu/serving) vanilla flavored yogurt containing starter cultures: Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus

Other: Probiotic strain of Bifidobacterium

Placebo Yogurt

PLACEBO COMPARATOR

Vanilla flavored yogurt containing starter cultures Streptococcus thermophilus and Lactobacillus delbrueckii subsp. Bulgaricus

Other: No Bifidobacterium

Interventions

Probiotic strain of BifidobacteriumOTHER

4 ounces (113g) of yogurt per day, for 14 days. Minimum Bifidobacterium dose of 1E+10 cfu/serving.

Bifidobacterium supplemented yogurt
No BifidobacteriumOTHER

4 ounces (113g) of yogurt per day, for 14 days. No bifidobacterium added.

Placebo Yogurt

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being female
  • Ability to speak and write English or Spanish
  • Willingness to refrain from specified probiotic supplements, during the 12 week trial (a list of prohibited products will be provided)
  • Have access to refrigeration and phone
  • Have a history of straining during bowel movements
  • Have a history of lumpy or hard stools

You may not qualify if:

  • Presence of an allergy or intolerance to any ingredients in yogurt
  • Morbid obesity, defined as a BMI\>40
  • Having inflammatory bowel disease
  • Having a history of malabsorption syndrome
  • Immunodeficiency, such as HIV or currently receiving chemotherapy
  • Consumption of any medications used to treat, prevent or cure diarrhea in the last month
  • Consumption of any medications used to treat, prevent or cure constipation in the last month
  • Diabetes mellitus
  • Thyroid disorders, including hypo- or hyperthyroidism
  • History of gastric, small bowel or colonic resection
  • Documented history of gastric emptying disorder
  • Consumption of narcotics, antipsychotic medications, or verapamil in the last month
  • Known pelvic outlet obstruction
  • Antibiotic usage within 4 weeks of enrollment
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Department of Family Medicine, Research Division

Washington D.C., District of Columbia, 20007, United States

Location

Study Officials

  • Dan Merenstein, MD

    Georgetown University

    PRINCIPAL INVESTIGATOR

  • Caren Palese, MD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 16, 2010

Study Start

October 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

February 11, 2013

Record last verified: 2012-12

Locations

US(1)