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

• Sponsor: BioGaia AB (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02592200
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.9
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Functional Constipation	Dietary Supplement: Lactobacillus gasseri DSM 27123; Dietary Supplement: Placebo	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 5, 2015
• Actual Primary Completion Date: Jun 21, 2016
• Actual Study Completion Date: Jul 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactobacillus gasseri Lactobacillus gasseri DSM 27123 capsules, 1×109 CFU (divided in two doses)	Dietary Supplement: Lactobacillus gasseri DSM 27123; 109 CFU (divided in two doses) per day for 28 days
Placebo Comparator: Placebo Placebo capsules (two doses)	Dietary Supplement: Placebo; Two doses per day for 28 days

Outcome Measures

Primary Outcome Measures

1. Change in frequency of complete spontaneous bowel movements (CSBMs) [Baseline and 4 weeks]

Secondary Outcome Measures

1. Change in Stool Consistency (Bristol Stool Form scale) [Baseline, week 1, 2, 3 and 4]

   Change in Bristol Stool Form Scale

2. Change in Patient-Assessment of Constipation Symptoms (PAC-SYM) [Baseline, week 1, 2, 3 and 4 (change from baseline)]

   Change in score

3. Change in Gastrointestinal Symptom Rating Scale (GSRS) [Baseline, week 1, 2, 3 and 4]

   Change in Score

4. 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.

5. Number of participants with treatement related adverse events [During the whole study - 4 weeks]

   Descriptive

6. Presence of Lactobacillus gasseri DSM 27123 in faeces [4 weeks]

   qPCR

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CTC, Akademiska Sjukhuset	Uppsala		Sweden	751 85

Sponsors and Collaborators

• BioGaia AB

Investigators

• Principal Investigator: Per Hellström, MD, PhD, Uppsala University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BioGaia AB
• ClinicalTrials.gov Identifier: NCT02592200
• Other Study ID Numbers: CSUB0092
• First Posted: Oct 30, 2015
• Last Update Posted: Jan 5, 2021
• Last Verified: Dec 1, 2020

• Keywords provided by BioGaia AB: Female; Constipation; Lactobacillus gasseri DSM 27123; Probiotics
• Additional relevant MeSH terms: Constipation

Study Results

No Results Posted as of Jan 5, 2021