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Effect of Yogurt With Polydextrose,L Acidophilus and B Lactis in Chronic Constipation

Primary Purpose

Constipation

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
yogurt containing: polydextrose L. acidophilus NCFM® B. lactis HN019
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring chronic constipation, Lactobacillus acidophilus NCFM, Bifidobacterium lactis HN019

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with chonic constipation
  • agachan between 10 and 20
  • bowel transit time with ingestion of 24 radiopaque markers (Sitzmarks) and retention of 80% of them on day 5

Exclusion Criteria:

  • Patients with hypothyroidism
  • antidepressant users
  • normal colonic
  • transit time (24 hrs or less) as well as higher than 96 hours were

Sites / Locations

  • University of Campinas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment Group

Placebol group

Arm Description

yogurt containing polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513) 1 time per day, for 30 days.

regular yogurt, 1 time per day for 30 days.

Outcomes

Primary Outcome Measures

Colonic transit

Secondary Outcome Measures

Full Information

First Posted
February 26, 2013
Last Updated
April 2, 2013
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01825434
Brief Title
Effect of Yogurt With Polydextrose,L Acidophilus and B Lactis in Chronic Constipation
Official Title
Effect of Yogurt Containing Polydextrose, Lactobacillus Acidophilus NCFM and Bifidobacterium Lactis HN019: a Randomized, Double-blind, Controlled Study in Chronic Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background and aims:Constipation is a frequent complaint and the combination of a prebiotic and probiotics would have a potentially synergic effect on the intestinal transit. The present study therefore aims to investigate the combination of polydextrose (Litesse®), L. acidophilus NCFM® and B. lactis HN019 in a yogurt on intestinal transit in subjects who suffer from constipation. Methods: Patients with constipation were randomly divided into two groups, Placebo Group (PG) and Treatment Group (TG), and had to eat 180 ml of unflavored yogurt every morning for 14 days. Those in the CG received only yogurt, while the TG received yogurt containing polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513). Expect that patients who took a combination of polydextrose has a decrease in the colonic transit time (CTT) when comparing initial and final transit time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
chronic constipation, Lactobacillus acidophilus NCFM, Bifidobacterium lactis HN019

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
yogurt containing polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513) 1 time per day, for 30 days.
Arm Title
Placebol group
Arm Type
Placebo Comparator
Arm Description
regular yogurt, 1 time per day for 30 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
yogurt containing: polydextrose L. acidophilus NCFM® B. lactis HN019
Other Intervention Name(s)
acidophilus NCFM® (ATCC 700396), lactis HN019 (AGAL NM97/09513)
Intervention Description
NCFM Group
Primary Outcome Measure Information:
Title
Colonic transit
Time Frame
Colonic transit time and Agachan score will be evaluated before and in day15 aftler yogurt ingestion. All particIpants will be followed for 30 days after the end of study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with chonic constipation agachan between 10 and 20 bowel transit time with ingestion of 24 radiopaque markers (Sitzmarks) and retention of 80% of them on day 5 Exclusion Criteria: Patients with hypothyroidism antidepressant users normal colonic transit time (24 hrs or less) as well as higher than 96 hours were
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio SR Coy, Ph.D
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Study Chair
Facility Information:
Facility Name
University of Campinas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083-887
Country
Brazil

12. IPD Sharing Statement

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Effect of Yogurt With Polydextrose,L Acidophilus and B Lactis in Chronic Constipation

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