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

December 30, 2020 updated by: BioGaia AB

A Double Blind Placebo-Controlled Study on the Effect of the Probiotic Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women - Proof of Concept

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 751 85
        • CTC, Akademiska Sjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lactobacillus gasseri
Lactobacillus gasseri DSM 27123 capsules, 1×109 CFU (divided in two doses)
Dietary supplement: Lactobacillus gasseri DSM 27123
109 CFU (divided in two doses) per day for 28 days
Placebo Comparator: Placebo
Placebo capsules (two doses)
Dietary supplement: Placebo
Two doses per day for 28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in frequency of complete spontaneous bowel movements (CSBMs)
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Stool Consistency (Bristol Stool Form scale)
Time Frame: Baseline, week 1, 2, 3 and 4
Change in Bristol Stool Form Scale
Baseline, week 1, 2, 3 and 4
Change in Patient-Assessment of Constipation Symptoms (PAC-SYM)
Time Frame: Baseline, week 1, 2, 3 and 4 (change from baseline)
Change in score
Baseline, week 1, 2, 3 and 4 (change from baseline)
Change in Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: Baseline, week 1, 2, 3 and 4
Change in Score
Baseline, week 1, 2, 3 and 4
Proportion of responders
Time Frame: 4 weeks
Proportion of responders is defined as subjects showing a mean increase of ≥1 CSBM per week during the treatment period (Day 1 to Day 28) compared to the baseline period (Day-14 to Day -1) or ≥3 CSBMs in the last week of the treatment period (Day 21 to Day 28). The subjects will record time and date of all CSBMs in the study diary.
4 weeks
Number of participants with treatement related adverse events
Time Frame: During the whole study - 4 weeks
Descriptive
During the whole study - 4 weeks
Presence of Lactobacillus gasseri DSM 27123 in faeces
Time Frame: 4 weeks
qPCR
4 weeks
Need for laxative medication
Time Frame: During the treatment period - 4 weeks
Time and date of laxative use will be recorded in the study diary by the subjects.
During the treatment period - 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioGaia AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Per Hellström, MD, PhD, Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSUB0092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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