Effect of Yogurt With Polydextrose,L Acidophilus and B Lactis in Chronic Constipation
Effect of Yogurt Containing Polydextrose, Lactobacillus Acidophilus NCFM and Bifidobacterium Lactis HN019: a Randomized, Double-blind, Controlled Study in Chronic Constipation
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2010
Shorter than P25 for not_applicable
1 active site
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
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 26, 2013
CompletedFirst Posted
Study publicly available on registry
April 5, 2013
CompletedApril 5, 2013
January 1, 2013
4 months
February 26, 2013
April 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Colonic transit
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
Study Arms (2)
Treatment Group
ACTIVE COMPARATORyogurt containing polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513) 1 time per day, for 30 days.
Placebol group
PLACEBO COMPARATORregular yogurt, 1 time per day for 30 days.
Interventions
NCFM Group
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with hypothyroidism
- antidepressant users
- normal colonic
- transit time (24 hrs or less) as well as higher than 96 hours were
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Campinas
Campinas, São Paulo, 13083-887, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Claudio SR Coy, Ph.D
University of Campinas, Brazil
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
February 26, 2013
First Posted
April 5, 2013
Study Start
February 1, 2010
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
April 5, 2013
Record last verified: 2013-01