Functional ConstipationNCT02592200
Effect of Lactobacillus Gasseri DSM 27123 on Functional Constipation in Healthy Women
A study testing Lactobacillus gasseri DSM 27123 in people with Functional Constipation, run by BioGaia AB at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Lactobacillus gasseri DSM 27123
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 5 Oct 2015to 31 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subjects have to meet all of the following criteria to be eligible to enter the study:
- Willing and able to provide informed consent
- Women aged 18-49 years at Visit 1
- BMI ≥18 and ≤29 at Visit 1
- Suffering of functional constipation as defined by the Rome III criteria for functional constipation
- Comply with the requirement not to use any other probiotic products from Visit 1 and throughout the study period
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- Not pregnant or breastfeeding
- Using adequate contraceptive measures
- Ability to understand and comply with the requirements of the study, as judged by the Investigator
Who cannot join
- Hypersensitivity or allergy to the investigational product, to chemically related products or to comparator/placebo
- Well-known, organic cause of constipation
- Anorectal pathology
- Previous gastrointestinal surgery
- Any alarming symptoms (i.e. rectal bleeding, weight loss, jaundice) as judged by the Investigator
- Spinal anomalies and injuries
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- Use of antibiotics within 4 weeks prior to Visit 1
- Use of products containing probiotics more than once a week in the previous 3 weeks
- Mental or behavioural disorders as judged by the Investigator
- Food allergy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Functional Constipation
- Being tested
- Lactobacillus gasseri DSM 27123, Placebo
- Keywords
- Female, Constipation, Lactobacillus gasseri DSM 27123, Probiotics
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus gasseri | Experimental | Lactobacillus gasseri DSM 27123 capsules, 1×109 CFU (divided in two doses) Receives: Dietary Supplement: Lactobacillus gasseri DSM 27123 |
| Placebo | Placebo comparator | Placebo capsules (two doses) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of complete spontaneous bowel movements (CSBMs)
Measured: Baseline and 4 weeks
Secondary outcomes (7)
Change in Stool Consistency (Bristol Stool Form scale)
Change in Bristol Stool Form Scale
Measured: Baseline, week 1, 2, 3 and 4
Change in Patient-Assessment of Constipation Symptoms (PAC-SYM)
Change in score
Measured: Baseline, week 1, 2, 3 and 4 (change from baseline)
Change in Gastrointestinal Symptom Rating Scale (GSRS)
Change in Score
Measured: 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.
Measured: 4 weeks
Number of participants with treatement related adverse events
Descriptive
Measured: During the whole study - 4 weeks
Presence of Lactobacillus gasseri DSM 27123 in faeces
qPCR
Measured: 4 weeks
Need for laxative medication
Time and date of laxative use will be recorded in the study diary by the subjects.
Measured: During the treatment period - 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start5 Oct 2015
- Primary completion21 Jun 2016
- Study completion31 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Hellström, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592200
- Sponsor's protocol ID
- CSUB0092
- Status last verified
- Dec 2020
- First submitted
- 22 Oct 2015
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02592200
- Acronym / sponsor ID
- CSUB0092
- Conditions
- Functional Constipation
- Keywords
- Female, Constipation, Lactobacillus gasseri DSM 27123, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2015 (actual)
- Primary completion
- 21 Jun 2016 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus gasseri | Experimental | Dietary Supplement: Lactobacillus gasseri DSM 27123Lactobacillus gasseri DSM 27123 capsules, 1×109 CFU (divided in two doses) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsules (two doses) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- The subjects have to meet all of the following criteria to be eligible to enter the study:
- Willing and able to provide informed consent
- Women aged 18-49 years at Visit 1
- BMI ≥18 and ≤29 at Visit 1
- Suffering of functional constipation as defined by the Rome III criteria for functional constipation
Key exclusion criteria (10 listed)
- Hypersensitivity or allergy to the investigational product, to chemically related products or to comparator/placebo
- Well-known, organic cause of constipation
- Anorectal pathology
- Previous gastrointestinal surgery
- Any alarming symptoms (i.e. rectal bleeding, weight loss, jaundice) as judged by the Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus gasseri DSM 27123109 CFU (divided in two doses) per day for 28 days | Dietary supplement | Lactobacillus gasseri |
| PlaceboTwo doses per day for 28 days | Dietary supplement | Placebo |
Primary outcome
Change in frequency of complete spontaneous bowel movements (CSBMs)
Time frame: Baseline and 4 weeks
7 secondary outcomes
Change in Stool Consistency (Bristol Stool Form scale)
Time frame: Baseline, week 1, 2, 3 and 4
Change in Patient-Assessment of Constipation Symptoms (PAC-SYM)
Time frame: Baseline, week 1, 2, 3 and 4 (change from baseline)
Change in Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Baseline, week 1, 2, 3 and 4
Proportion of responders
Time frame: 4 weeks
Number of participants with treatement related adverse events
Time frame: During the whole study - 4 weeks
Presence of Lactobacillus gasseri DSM 27123 in faeces
Time frame: 4 weeks
Need for laxative medication
Time frame: During the treatment period - 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Related trials for Functional Constipation
RecruitingPhase 2
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This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
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Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Hellström, MD, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus gasseri DSM 27123 in people with Functional Constipation, run by BioGaia AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of complete spontaneous bowel movements (CSBMs) (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.