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

Primary Purpose

Functional Constipation

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Lactobacillus gasseri DSM 27123
Placebo
Sponsored by
BioGaia AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Constipation focused on measuring Female, Constipation, Lactobacillus gasseri DSM 27123, Probiotics

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts 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

Sites / Locations

  • CTC, Akademiska Sjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactobacillus gasseri

Placebo

Arm Description

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

Placebo capsules (two doses)

Outcomes

Primary Outcome Measures

Change in frequency of complete spontaneous bowel movements (CSBMs)

Secondary Outcome Measures

Change in Stool Consistency (Bristol Stool Form scale)
Change in Bristol Stool Form Scale
Change in Patient-Assessment of Constipation Symptoms (PAC-SYM)
Change in score
Change in Gastrointestinal Symptom Rating Scale (GSRS)
Change in Score
Proportion of responders
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.
Number of participants with treatement related adverse events
Descriptive
Presence of Lactobacillus gasseri DSM 27123 in faeces
qPCR
Need for laxative medication
Time and date of laxative use will be recorded in the study diary by the subjects.

Full Information

First Posted
October 22, 2015
Last Updated
December 30, 2020
Sponsor
BioGaia AB
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1. Study Identification

Unique Protocol Identification Number
NCT02592200
Brief Title
Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 5, 2015 (Actual)
Primary Completion Date
June 21, 2016 (Actual)
Study Completion Date
July 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioGaia AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation
Keywords
Female, Constipation, Lactobacillus gasseri DSM 27123, Probiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus gasseri
Arm Type
Experimental
Arm Description
Lactobacillus gasseri DSM 27123 capsules, 1×109 CFU (divided in two doses)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules (two doses)
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus gasseri DSM 27123
Intervention Description
109 CFU (divided in two doses) per day for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Two doses per day for 28 days
Primary Outcome Measure Information:
Title
Change in frequency of complete spontaneous bowel movements (CSBMs)
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change in Stool Consistency (Bristol Stool Form scale)
Description
Change in Bristol Stool Form Scale
Time Frame
Baseline, week 1, 2, 3 and 4
Title
Change in Patient-Assessment of Constipation Symptoms (PAC-SYM)
Description
Change in score
Time Frame
Baseline, week 1, 2, 3 and 4 (change from baseline)
Title
Change in Gastrointestinal Symptom Rating Scale (GSRS)
Description
Change in Score
Time Frame
Baseline, week 1, 2, 3 and 4
Title
Proportion of responders
Description
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.
Time Frame
4 weeks
Title
Number of participants with treatement related adverse events
Description
Descriptive
Time Frame
During the whole study - 4 weeks
Title
Presence of Lactobacillus gasseri DSM 27123 in faeces
Description
qPCR
Time Frame
4 weeks
Title
Need for laxative medication
Description
Time and date of laxative use will be recorded in the study diary by the subjects.
Time Frame
During the treatment period - 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The subjects have to meet all of the following criteria to be eligible to enter the study: Willing and able to provide informed consent Women aged 18-49 years at Visit 1 BMI ≥18 and ≤29 at Visit 1 Suffering of functional constipation as defined by the Rome III criteria for functional constipation Comply with the requirement not to use any other probiotic products from Visit 1 and throughout the study period Not pregnant or breastfeeding Using adequate contraceptive measures Ability to understand and comply with the requirements of the study, as judged by the Investigator Exclusion Criteria: Hypersensitivity or allergy to the investigational product, to chemically related products or to comparator/placebo Well-known, organic cause of constipation Anorectal pathology Previous gastrointestinal surgery Any alarming symptoms (i.e. rectal bleeding, weight loss, jaundice) as judged by the Investigator Spinal anomalies and injuries Use of antibiotics within 4 weeks prior to Visit 1 Use of products containing probiotics more than once a week in the previous 3 weeks Mental or behavioural disorders as judged by the Investigator Food allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Hellström, MD, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CTC, Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden

12. IPD Sharing Statement

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

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