Efficacy Evaluation of Probiotic Product on Bowel Habits in Healthy Subjects

NCT01375712 | Completed

• 1 other identifier: YAK_BSFS
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief 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

Constipation

Keywords

Hard or lumpy stools; Stool consistency; Stool frequency; Constipation related symptoms; Constipation related quality of life

Outcome Measures

Primary Outcomes (1)

• Change in the proportion of subjects who produce hard or lumpy stools not less than 25%(≥25%) of weekly number of bowel movements

  Hard or lumpy stools are defined as stools with Bristol Stool Form Scale score 1 or 2. Incidence of hard or lumpy stools is calculated by weekly basis.

  During pre-treatment (2 weeks) and treatment (8 weeks)

Secondary Outcomes (5)

• Weekly average Bristol Stool Form Scale score

  During pre-treatment (2 weeks) and treatment (8 weeks)

• Weekly number of spontaneous bowel movements

  During pre-treatment (2 weeks) and treatment (8 weeks)

• Weekly number of spontaneous complete bowel movements

  During pre-treatment (2 weeks) and treatment (8 weeks)

• Patient Assessment of Constipation Symptoms (PAC-SYM) score

  6 points (Days 1, 15, 29, 43, 57 and 71)

• Patient Assessment of Constipation Quality of Life (PAC-QOL) score

  6 points (Days 1, 15, 29, 43, 57 and 71)

Study Arms (2)

Fermented milk

ACTIVE COMPARATOR

Fermented milk containing Lactobacillus casei strain Shirota, 65 ml in a bottle, consume 1 bottle per day.

Dietary Supplement: Fermented milk containing Lactobacillus casei strain Shirota

Placebo

PLACEBO COMPARATOR

Non-fermented milk without Lactobacillus casei strain Shirota, 65 ml in a bottle, consume 1 bottle per day.

Dietary Supplement: Placebo

Interventions

Fermented milk containing Lactobacillus casei strain Shirota DIETARY_SUPPLEMENT

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.

Also known as: Commercial name: Yakult

Fermented milk

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• is informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and give written consent to participate in the study prior to the start of any study-related procedures
• is healthy female or male, 18-65 years of age, inclusive
• is conscious of having hard or lumpy stools in daily life
• has an average Bristol Stool Form Scale score \<3.0 per bowel movement
• female subjects of childbearing potential should use a reliable method of contraception

You may not qualify if:

• is under the age of legal consent
• is mentally or legally incapacitated
• is treated by a doctor for her/his constipation
• has a history of gastrointestinal surgery except for appendectomy
• has a history of chronic gastrointestinal diseases, including but not limited to inflammatory bowel diseases
• has a severe gastrointestinal disorder
• has clinically relevant medical conditions, e.g., renal, hepatic, pulmonary, cardiac, hematological, endocrinological, neurological, or psychiatric conditions
• is pregnant or wanting to become pregnant during the course of the study
• is unable to refrain from or anticipates the use of any medication (including laxatives, diuretics, prescription and non-prescription drugs, vitamins and herbal supplements), except for paracetamol, oral contraceptives, or hormonal replacement therapy during the screening visit and for the duration of the study
• has a history of drug and/or alcohol abuse
• has milk allergies
• is intolerant to lactose

Sponsors & Collaborators

• Yakult Honsha Co., LTD: lead

Study Sites (1)

Harrison Clinical Research Deutschland GmbH

Munich, 80636, Germany

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Heiko Ilchmann

  Harrison Clinical Research Deutschland GmbH (Clinical Unit)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 17, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 31, 2012

Record last verified: 2012-01

Locations

DE (1)