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

Functional Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592200
• Other study ID #: CSUB0092
• Status: Completed
• Phase: N/A
• Start date: October 5, 2015
• Est. completion date: July 31, 2016

Study information

• Verified date: December 2020
• Source: BioGaia AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 31, 2016
• Est. primary completion date: June 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Dietary Supplement:
• Lactobacillus gasseri DSM 27123
109 CFU (divided in two doses) per day for 28 days
• Placebo
Two doses per day for 28 days

Locations

Country	Name	City	State
Sweden	CTC, Akademiska Sjukhuset	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
BioGaia AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in frequency of complete spontaneous bowel movements (CSBMs)		Baseline and 4 weeks
Secondary	Change in Stool Consistency (Bristol Stool Form scale)	Change in Bristol Stool Form Scale	Baseline, week 1, 2, 3 and 4
Secondary	Change in Patient-Assessment of Constipation Symptoms (PAC-SYM)	Change in score	Baseline, week 1, 2, 3 and 4 (change from baseline)
Secondary	Change in Gastrointestinal Symptom Rating Scale (GSRS)	Change in Score	Baseline, week 1, 2, 3 and 4
Secondary	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
Secondary	Number of participants with treatement related adverse events	Descriptive	During the whole study - 4 weeks
Secondary	Presence of Lactobacillus gasseri DSM 27123 in faeces	qPCR	4 weeks
Secondary	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