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

NCT ID: NCT02592200

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-05
• Study Completion Date: 2016-07-31

Brief Summary

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.

Detailed 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

Conditions

Functional Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lactobacillus gasseri

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

Group Type: EXPERIMENTAL

Lactobacillus gasseri DSM 27123

Intervention Type: DIETARY_SUPPLEMENT

109 CFU (divided in two doses) per day for 28 days

Placebo

Placebo capsules (two doses)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Two doses per day for 28 days

Interventions

Lactobacillus gasseri DSM 27123

109 CFU (divided in two doses) per day for 28 days

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Two doses per day for 28 days

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

BioGaia AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per Hellström, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

CTC, Akademiska Sjukhuset

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

CSUB0092

Identifier Type: -

Identifier Source: org_study_id