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

NCT ID: NCT01825434

Last Updated: 2013-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment Group

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

Group Type ACTIVE_COMPARATOR

yogurt containing: polydextrose L. acidophilus NCFM® B. lactis HN019

Intervention Type DIETARY_SUPPLEMENT

NCFM Group

Placebol group

regular yogurt, 1 time per day for 30 days.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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yogurt containing: polydextrose L. acidophilus NCFM® B. lactis HN019

NCFM Group

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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acidophilus NCFM® (ATCC 700396) lactis HN019 (AGAL NM97/09513)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Claudio Saddy Rodrigues Coy

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudio SR Coy, Ph.D

Role: STUDY_CHAIR

University of Campinas, Brazil

Locations

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University of Campinas

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CE 454/2008

Identifier Type: -

Identifier Source: org_study_id

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