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

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: Completed
• Conditions: Functional Constipation
• Intervention / Treatment: Dietary supplement: Lactobacillus gasseri DSM 27123; Dietary supplement: Placebo

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: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Change in frequency of complete spontaneous bowel movements (CSBMs)	Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stool Consistency (Bristol Stool Form scale)	Change in Bristol Stool Form Scale	Baseline, week 1, 2, 3 and 4
Change in Patient-Assessment of Constipation Symptoms (PAC-SYM)	Change in score	Baseline, week 1, 2, 3 and 4 (change from baseline)
Change in Gastrointestinal Symptom Rating Scale (GSRS)	Change in Score	Baseline, week 1, 2, 3 and 4
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.	4 weeks
Number of participants with treatement related adverse events	Descriptive	During the whole study - 4 weeks
Presence of Lactobacillus gasseri DSM 27123 in faeces	qPCR	4 weeks
Need for laxative medication	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

• Sponsor: BioGaia AB
• Investigators: Principal Investigator: Per Hellström, MD, PhD, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2015
• Primary Completion (Actual): June 21, 2016
• Study Completion (Actual): July 31, 2016

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Constipation; Probiotics; Female; Lactobacillus gasseri DSM 27123
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: CSUB0092