Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women

BioGaia

Status: Completed

Conditions: Functional Constipation

Treatments: Dietary Supplement: Lactobacillus gasseri DSM 27123; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02592200

CSUB0092

Details and patient eligibility

About

The primary objective is to determine the change in frequency of complete spontaneous bowel movements (CSBMs) after 4 weeks of oral supplementation with Lactobacillus gasseri DSM 27123 in healthy adult women with functional constipation.

Full description

Subjects to complete study diaries, number of SBM, CSBM, form of faeces (according to the Bristol Stool Form scale), pain during defecation (according to the visual analogue scale [VAS] 0-100), time spent at each evacuation, episodes of faecal incontinence, number of ingested capsules of investigational product will be recorded daily by the subjects

Enrollment: 40 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The subjects have to meet all of the following criteria to be eligible to enter the study:

1. Willing and able to provide informed consent
2. Women aged 18-49 years at Visit 1
3. BMI ≥18 and ≤29 at Visit 1
4. Suffering of functional constipation as defined by the Rome III criteria for functional constipation
5. Comply with the requirement not to use any other probiotic products from Visit 1 and throughout the study period
6. Not pregnant or breastfeeding
7. Using adequate contraceptive measures
8. Ability to understand and comply with the requirements of the study, as judged by the Investigator

Exclusion criteria

1. Hypersensitivity or allergy to the investigational product, to chemically related products or to comparator/placebo
2. Well-known, organic cause of constipation
3. Anorectal pathology
4. Previous gastrointestinal surgery
5. Any alarming symptoms (i.e. rectal bleeding, weight loss, jaundice) as judged by the Investigator
6. Spinal anomalies and injuries
7. Use of antibiotics within 4 weeks prior to Visit 1
8. Use of products containing probiotics more than once a week in the previous 3 weeks
9. Mental or behavioural disorders as judged by the Investigator
10. Food allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Lactobacillus gasseri

Experimental group

Description:

Lactobacillus gasseri DSM 27123 capsules, 1×109 CFU (divided in two doses)

Treatment:

Dietary Supplement: Lactobacillus gasseri DSM 27123

Placebo

Placebo Comparator group

Description:

Placebo capsules (two doses)

Treatment:

Dietary Supplement: Placebo