NCT02091115

Brief Summary

Constipation is a disorder which can be associated with various pathologies or could also be an effect of the consumption of drugs, improper diet and life style. Is increasingly common the utilization of probiotics in foods. Probiotics are defined as live microorganisms administered in adequate amounts confer a health benefit to the host, the most widely used for milk-based drinks are lactic bacteria Lactobacillus and Bifidobacterium. The objective of the present study is to assess the effectiveness of the consumption of dairy beverage enriched with probiotic for the treatment of the symptoms of constipation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

July 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
Last Updated

March 19, 2014

Status Verified

March 1, 2014

Enrollment Period

Same day

First QC Date

March 14, 2014

Last Update Submit

March 18, 2014

Conditions

Constipation

Keywords

ConstipationROMA III criteriaScale Bristol

Outcome Measures

Primary Outcomes (1)

  • Decrease in symptoms of constipation

    First application of Rome III criteria and Scale Bristol in July 2013. And the second measure has occurred after the consumption of dairy drink for 60 days and was held in September 2013.

    Up to two months

Secondary Outcomes (1)

  • Increase in frequency evacuations

    Up to two months

Other Outcomes (1)

  • Appearance of feces.

    Up to two months

Study Arms (2)

Dairy drink

PLACEBO COMPARATOR

Patients received dairy drink for 60 days and were instructed to consume a glass of 150 mL daily.

Dietary Supplement: Dairy drink

Dairy drink with probiotic culture

ACTIVE COMPARATOR

Patients received dairy drink with probiotic culture for 60 days and were instructed to consume a glass of 150 mL daily.

Dietary Supplement: dairy drink with probiotic culture

Interventions

dairy drink with probiotic cultureDIETARY_SUPPLEMENT

The participants were instructed to consume the dairy drink with probiotic culture containing animalis bifidobacterium with 3.2 x 107 UFC for 60 days and a glass of 150 ml daily.

Dairy drink with probiotic culture
Dairy drinkDIETARY_SUPPLEMENT
Dairy drink

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women

You may not qualify if:

  • diabetic women,
  • pregnant,
  • breastfeeding women,
  • gastrointestinal symptoms,
  • gastrointestinal pathologies preliminary,
  • current or recent use of antibiotics, antiinflammatory or other drugs,
  • womens with pathologies that alter the bowel habits,
  • food allergies and intolerances,
  • ulcerative colitis,
  • Crohn's disease and irritable bowel syndrome,
  • patients having lactose intolerance or do not like milk drink,
  • patients showing them to use other types of probiotic food, prebiotic and symbiotic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Center Univates

Lajeado, Rio Grande do Sul, 95900-000, Brazil

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thaís R Moreira, Professor

    University Center Univates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master in Medical Sciences and Professor

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 19, 2014

Study Start

July 1, 2013

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

March 19, 2014

Record last verified: 2014-03

Locations

BR(1)