Functional Constipation
Conditions
Keywords
Female, Constipation, Lactobacillus gasseri DSM 27123, Probiotics
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
Interventions
DIETARY_SUPPLEMENTLactobacillus gasseri DSM 27123
109 CFU (divided in two doses) per day for 28 days
DIETARY_SUPPLEMENTPlacebo
Two doses per day for 28 days
Sponsors
BioGaia AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in frequency of complete spontaneous bowel movements (CSBMs) | Baseline and 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Assessment of Constipation Symptoms (PAC-SYM) | Baseline, week 1, 2, 3 and 4 (change from baseline) | Change in score |
| Change in Gastrointestinal Symptom Rating Scale (GSRS) | Baseline, week 1, 2, 3 and 4 | Change in Score |
| Proportion of responders | 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. |
| Change in Stool Consistency (Bristol Stool Form scale) | Baseline, week 1, 2, 3 and 4 | Change in Bristol Stool Form Scale |
| Presence of Lactobacillus gasseri DSM 27123 in faeces | 4 weeks | qPCR |
| Need for laxative medication | During the treatment period - 4 weeks | Time and date of laxative use will be recorded in the study diary by the subjects. |
| Number of participants with treatement related adverse events | During the whole study - 4 weeks | Descriptive |
Countries
Sweden
Outcome results
None listed