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

BioGaia AB40 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Functional Constipation

Interventions

Lactobacillus gasseri DSM 27123DIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

Two doses per day for 28 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CTC, Akademiska Sjukhuset

Uppsala, Sweden

Outcomes

Primary Outcomes

Change in frequency of complete spontaneous bowel movements (CSBMs)

Time frame: Baseline and 4 weeks

Secondary Outcomes

Change in Stool Consistency (Bristol Stool Form scale)

Change in Bristol Stool Form Scale

Time frame: Baseline, week 1, 2, 3 and 4

Change in Patient-Assessment of Constipation Symptoms (PAC-SYM)

Change in score

Time frame: Baseline, week 1, 2, 3 and 4 (change from baseline)

Change in Gastrointestinal Symptom Rating Scale (GSRS)

Change in Score

Time frame: 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.

Time frame: 4 weeks

Number of participants with treatement related adverse events

Descriptive

Time frame: During the whole study - 4 weeks

Presence of Lactobacillus gasseri DSM 27123 in faeces

qPCR

Time frame: 4 weeks

Need for laxative medication

Time and date of laxative use will be recorded in the study diary by the subjects.

Data from ClinicalTrials.gov

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