Clinical trial NCT02592200: 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
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation
Keywords: Female
Constipation
Lactobacillus gasseri DSM 27123
Probiotics
Lead sponsor: BioGaia AB
Sponsor class: INDUSTRY
First posted: 2015-10-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in frequency of complete spontaneous bowel movements (CSBMs)
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change in Stool Consistency (Bristol Stool Form scale)
timeFrame: Baseline, week 1, 2, 3 and 4
measure: Change in Patient-Assessment of Constipation Symptoms (PAC-SYM)
timeFrame: Baseline, week 1, 2, 3 and 4 (change from baseline)
measure: Change in Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Baseline, week 1, 2, 3 and 4
measure: Proportion of responders
timeFrame: 4 weeks
measure: Number of participants with treatement related adverse events
timeFrame: During the whole study - 4 weeks
measure: Presence of Lactobacillus gasseri DSM 27123 in faeces
timeFrame: 4 weeks
measure: Need for laxative medication
timeFrame: During the treatment period - 4 weeks
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: CTC, Akademiska Sjukhuset
Study officials:
affiliation: Uppsala University
name: Per Hellström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: