Effect of Bifidobacterium Lactis HN019 on Colonic Transit Time and Digestive Symptoms

Fonterra

Status and phase: Completed; Phase 3; Phase 2

Conditions: Gastrointestinal Symptoms

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Bifidobacterium lactis HN019

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01171014

#08-SPUS-o6-FON-01

Details and patient eligibility

About

The purpose of this study was to investigate the dose response effect of Bifidobacterium lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms.

Enrollment: 100 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy males and females aged 25 to 65 years
• stool type 2-4 on the Bristol Stool Chart
• 1 to 3 bowel movements per week

Exclusion criteria

• use of any probiotic product intended to improve gastrointestinal function within the 2 weeks preceding study entry
• major chronic and uncontrolled systemic medical conditions
• severe gastrointestinal conditions known to prolong CTT
• lactose intolerance
• chronic diarrhea
• gastric bypass surgery or lap band insertion for weight loss
• regular laxative use
• pregnant or breast-feeding women

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 3 patient groups, including a placebo group

High dose probiotic

Experimental group

Description:

Bifidobacterium lactis HN019, 10 billion cfu/day

Treatment:

Dietary Supplement: Bifidobacterium lactis HN019

Dietary Supplement: Bifidobacterium lactis HN019

Low dose probiotic

Experimental group

Description:

Bifidobacterium lactis HN019, 1 billion cfu/day

Treatment:

Dietary Supplement: Bifidobacterium lactis HN019

Dietary Supplement: Bifidobacterium lactis HN019

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo