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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Functional Constipation

Intervention / Treatment
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* Dietary Supplement: Lactobacillus gasseri DSM 27123
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus gasseri<br>Lactobacillus gasseri DSM 27123 capsules, 1×109 CFU (divided in two doses) | Dietary Supplement: Lactobacillus gasseri DSM 27123<br>* 109 CFU (divided in two doses) per day for 28 days<br>|
| Placebo Comparator: Placebo<br>Placebo capsules (two doses) | Dietary Supplement: Placebo<br>* Two doses per day for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female, Constipation, Lactobacillus gasseri DSM 27123, Probiotics