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Efficacy Evaluation of Probiotic Product on Bowel Habits in Healthy Subjects

NCT01375712 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2012-01-31

No results posted yet for this study

Summary

The objective of this study is to evaluate if consumption of fermented milk containing Lactobacillus casei strain Shirota has an impact on stool consistency, stool frequency, constipation-related symptoms, and quality of life in subjects who frequently have hard or lumpy stools.

Conditions

Interventions

DIETARY_SUPPLEMENT

Fermented milk containing Lactobacillus casei strain Shirota

A fermented milk containing Lactobacillus casei strain Shirota, 65 ml for oral administration, 1 bottle per day for 8 weeks (56 days). One bottle of the drink contains: 42.9 kcal/182 kJ; less than 0.1 g of fat; 9.6 g of carbohydrate; 0.01 g of sodium; 0.9 g of protein; and at least 6.5 x 10\^9 colony-forming units of Lactobacillus casei strain Shirota.

DIETARY_SUPPLEMENT

Placebo

Non-fermented milk without Lactobacillus casei strain Shirota, 65 ml for oral administration, 1 bottle per day for 8 weeks (56 days). One bottle of the drink contains: 42.9 kcal/182 kJ; less than 0.1 g of fat; 9.6 g of carbohydrate; 0.01 g of sodium; and 0.9 g of protein.

Sponsors & Collaborators

  • Yakult Honsha Co., LTD

    lead INDUSTRY

Principal Investigators

  • Heiko Ilchmann · Harrison Clinical Research Deutschland GmbH (Clinical Unit)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01375712 on ClinicalTrials.gov