HealthyNCT02131870
Study of the Iron Absorption From Capsules Containing Lactobacilli and Iron
A study of Healthy, run by Probi AB at 1 site in Sweden.
Trial summary
The purpose of this study is to study the effect of a probiotic product on iron absorption in healthy females of child-bearing age. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- Start not givento Jul 2014
- 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 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Age ≥19 and ≤45 years
- Hb >117g/L
Who cannot join
- Gastrointestinal diseases
- Metabolic diseases
- Use of other probiotic products during the study and 2 weeks before the study start
- Pregnant or breast-feeding
- A serum ferritin level >60 µg/L
- Medication (oral contraceptives allowed)
Show all 9Show fewer
- Intake of dietary supplements (incl. iron) during the study and two weeks before the study start
- No blood donation in the last 2 months
- High C-reactive protein levels
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Internal Medicin and Clinical Nutrition, the Sahlgrenska Academy, Gothenburg University
Gothenburg, 405 30
About this study
The purpose of this study is to study the effect of a probiotic product on iron absorption in healthy females of child-bearing age.
- Conditions
- Healthy
- Being tested
- L plantarum DSM 9843 or placebo
- Keywords
- iron absorption, healthy females, child bearing age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L plantarum DSM 9843 or placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| L plantarum DSM 9843 | Active comparator | Not described Receives: Dietary Supplement: L plantarum DSM 9843 or placebo |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: L plantarum DSM 9843 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron absorption ratio in blood samples
Iron absorption will be estimated by measuring the isotope ratio (55Fe/59Fe) in blood after addition of iron isotopes in test meals (55Fe in placebo meal, 59Fe in L plantarum DSM 9843 meal).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Primary completionJul 2014
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 HealthyStudies 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
- Basic science
- Intervention model
- Crossover
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131870
- Sponsor's protocol ID
- ProIron
- Status last verified
- Aug 2014
- First submitted
- 30 Apr 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hoppe M, Onning G, Hulthen L. Freeze-dried Lactobacillus plantarum 299v increases iron absorption in young females-Double isotope sequential single-blind studies in menstruating women. PLoS One. 2017 Dec 13;12(12):e0189141. doi: 10.1371/journal.pone.0189141. eCollection 2017.
PubMed 29236734
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Iron Absorption From Capsules Containing Lactobacilli and Iron
- ClinicalTrials.gov ID
- NCT02131870
- Acronym / sponsor ID
- ProIron
- Conditions
- Healthy
- Keywords
- iron absorption, healthy females, child bearing age
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Primary completion
- Jul 2014 (actual)
- First posted
- 6 May 2014 (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 study the effect of a probiotic product on iron absorption in healthy females of child-bearing age.
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L plantarum DSM 9843 | Active comparator | Dietary Supplement: L plantarum DSM 9843 or placebo |
| Placebo | Placebo comparator | Dietary Supplement: L plantarum DSM 9843 or placebo |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- Age ≥19 and ≤45 years
- Hb >117g/L
Key exclusion criteria (9 listed)
- Gastrointestinal diseases
- Metabolic diseases
- Use of other probiotic products during the study and 2 weeks before the study start
- Pregnant or breast-feeding
- A serum ferritin level >60 µg/L
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 |
|---|---|---|
| L plantarum DSM 9843 or placebo | Dietary supplement | L plantarum DSM 9843, Placebo |
Primary outcome
Iron absorption ratio in blood samples
Time frame: 14 days
Iron absorption will be estimated by measuring the isotope ratio (55Fe/59Fe) in blood after addition of iron isotopes in test meals (55Fe in placebo meal, 59Fe in L plantarum DSM 9843 meal).
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 15 Aug 2014.
- Derived from this study: PubMed 29236734Hoppe M, Onning G, Hulthen L. Freeze-dried Lactobacillus plantarum 299v increases iron absorption in young females-Double isotope sequential single-blind studies in menstruating women. PLoS One. 2017 Dec 13;12(12):e0189141. doi: 10.1371/journal.pone.0189141. eCollection 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthy, run by Probi 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 3 inclusion and 9 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 15 Aug 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.
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?
Iron absorption ratio in blood samples (time frame: 14 days). 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 NCT02131870, 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 15 Aug 2014.