ConstipationPhase 3NCT01837940
Efficacy of a Dietary Supplementation With Lactobacillus Reuteri for Digestive Health in an Elderly Population
A Phase 3 study testing Lactobacillus reuteri DSM 17938 in people with Constipation and Diarrhea, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate the effect of a daily supplement consisting of the probiotic bacteria, Lactobacillus reuteri, on the digestive health among persons 65 years and older. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Constipation, Diarrhea, Indigestion
- What is being tested?
- Lactobacillus reuteri DSM 17938
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2013to Sep 2013
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥ 65 years
- Informed consent signed by study participant or legal guardian
Who cannot join
- Known gastrointestinal disease, with strictures, malignance's and ischemia.
- Inflammatory bowel diseases (IBD)
- Participation in other clinical trials in the past three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Dietary Supplementation With Lactobacillus Reuteri DSM 17938 for Digestive Health in an Elderly Population
The purpose of this study is to investigate the effect of a daily supplement consisting of the probiotic bacteria, Lactobacillus reuteri, on the digestive health among persons 65 years and older.
Read the detailed description
The overall purpose of the study is to investigate the effect of daily supplementation, during a three months period, of L. reuteri on digestive health in an elderly Swedish population, residing in the municipality of Örebro. In addition an extensive screening of the study population in regard of overall health status, functionality and well-being as well as the composition of the gut microbiome will be assessed prior study start through the collection of baseline data
- Conditions
- Constipation, Diarrhea, Indigestion, Reflux, Abdominal Pain
- Being tested
- Placebo, Lactobacillus reuteri DSM 17938
- Medical subject headings
- Constipation, Diarrhea, Dyspepsia, Gastroesophageal Reflux, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Galactooligosaccharide (GOS) and rhamnose in a powder formulation
Lactobacillus reuteri DSM 17938Dietary supplement
Lactobacillus reuteri DSM17938, Galactooligosaccharide (GOS), rhamnose in a powder formulation
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| dietary supplement | Active comparator | Lactobacillus reuteri DSM 17938 Receives: Dietary Supplement: Lactobacillus reuteri DSM 17938 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Gastrointestinal symptoms to 3months
Gastrointestinal discomfort will be assessed through the gastrointestinal symptoms rating score (GSRS), a clinical rating scale for gastrointestinal symptoms. The GSRS includes 15 symptoms and uses a 7-point Likert scale in which 1 represents the most positive option and 7 the most negative.
Measured: Baseline, at 2 months and at 3months/study end
Secondary outcomes (1)
Change in use of intestinal motility regulating substances during the 3-month intervention period
Intestinal motility regulating substances (e.g anti-diarrheal and anti-constipation medication)
Measured: at baseline and end of study ( 3months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Responsible party
- Principal investigator, Robert Brummer, Örebro University, Sweden
- Investigators
- Robert Jan Brummer, MD, PhD, Principal investigator, Örebro Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837940
- Sponsor's protocol ID
- 2012/309
- Status last verified
- Dec 2014
- First submitted
- 26 Mar 2013
- Last updated
- 5 Dec 2014
- Results posted
- No
Publications
Ostlund-Lagerstrom L, Kihlgren A, Repsilber D, Bjorksten B, Brummer RJ, Schoultz I. Probiotic administration among free-living older adults: a double blinded, randomized, placebo-controlled clinical trial. Nutr J. 2016 Sep 10;15(1):80. doi: 10.1186/s12937-016-0198-1.
PubMed 27612653
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Dietary Supplementation With Lactobacillus Reuteri DSM 17938 for Digestive Health in an Elderly Population
- ClinicalTrials.gov ID
- NCT01837940
- Acronym / sponsor ID
- 2012/309
- Conditions
- Constipation, Diarrhea, Indigestion, Reflux, Abdominal Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 23 Apr 2013 (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 purpose of this study is to investigate the effect of a daily supplement consisting of the probiotic bacteria, Lactobacillus reuteri, on the digestive health among persons 65 years and older.
Detailed description
The overall purpose of the study is to investigate the effect of daily supplementation, during a three months period, of L. reuteri on digestive health in an elderly Swedish population, residing in the municipality of Örebro. In addition an extensive screening of the study population in regard of overall health status, functionality and well-being as well as the composition of the gut microbiome will be assessed prior study start through the collection of baseline data
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 |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| dietary supplement | Active comparator | Dietary Supplement: Lactobacillus reuteri DSM 17938Lactobacillus reuteri DSM 17938 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age ≥ 65 years
- Informed consent signed by study participant or legal guardian
Key exclusion criteria (3 listed)
- Known gastrointestinal disease, with strictures, malignance's and ischemia.
- Inflammatory bowel diseases (IBD)
- Participation in other clinical trials in the past three months.
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 |
|---|---|---|
| PlaceboGalactooligosaccharide (GOS) and rhamnose in a powder formulation | Dietary supplement | Placebo |
| Lactobacillus reuteri DSM 17938Lactobacillus reuteri DSM17938, Galactooligosaccharide (GOS), rhamnose in a powder formulation | Dietary supplement | dietary supplement |
Primary outcome
Change from baseline Gastrointestinal symptoms to 3months
Time frame: Baseline, at 2 months and at 3months/study end
Gastrointestinal discomfort will be assessed through the gastrointestinal symptoms rating score (GSRS), a clinical rating scale for gastrointestinal symptoms. The GSRS includes 15 symptoms and uses a 7-point Likert scale in which 1 represents the most positive option and 7 the most negative.
1 secondary outcome
Change in use of intestinal motility regulating substances during the 3-month intervention period
Time frame: at baseline and end of study ( 3months)
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 Dec 2014.
- Derived from this study: PubMed 27612653Ostlund-Lagerstrom L, Kihlgren A, Repsilber D, Bjorksten B, Brummer RJ, Schoultz I. Probiotic administration among free-living older adults: a double blinded, randomized, placebo-controlled clinical trial. Nutr J. 2016 Sep 10;15(1):80. doi: 10.1186/s12937-016-0198-1.
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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.
Robert Jan Brummer, MD, PhD principal investigator
Örebro Universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactobacillus reuteri DSM 17938 in people with Constipation and Diarrhea, run by Örebro University, Sweden 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 2 inclusion and 3 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 Dec 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 from baseline Gastrointestinal symptoms to 3months (time frame: Baseline, at 2 months and at 3months/study end). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01837940, which also lists 1 linked publication.
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 Dec 2014.