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

Constipation Clinical Trial

Official title:

Effect of Yogurt Containing Polydextrose, Lactobacillus Acidophilus NCFM and Bifidobacterium Lactis HN019: a Randomized, Double-blind, Controlled Study in Chronic Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825434
• Other study ID #: CE 454/2008
• Status: Completed
• Phase: N/A
• First received: February 26, 2013
• Last updated: April 2, 2013
• Start date: February 2010
• Est. completion date: June 2010

Study information

• Verified date: January 2013
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• yogurt containing: polydextrose L. acidophilus NCFM® B. lactis HN019
NCFM Group

Locations

Country	Name	City	State
Brazil	University of Campinas	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes