Gestational Diabetes Mellitus in PregnancyNCT04009889
Impact of Oral Probiotic Blend on Pregnancy Outcome
A study testing capsule containing a probiotic blend of 5 different Lactobacilli and capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics. in people with Gestational Diabetes Mellitus in Pregnancy, run by i-Health, Inc. at 1 site in Germany.
Trial summary
The aim of this study is, to investigate the effect of oral intake of Lactobacillus rhamnosus GG (ATCC 53103), Lactobacillus crispatus Lbv88, Lactobacillus rhamnosus Lbv96, Lactobacillus jensenii Lbv116 Lactobacillus gasseri Lbv150 on outcomes of pregnancy and microbiota and their interrelation. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- capsule containing a probiotic blend of 5 different Lactobacilli and capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteGermany
- Study dates
- 5 Apr 2018to 12 Jun 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pregnant women aged > 18 years in the < 14 week of pregnancy
- willing to consume the study product during pregnancy ( V1 to delivery)
- willingness to abstain from probiotic food and supplements containing probiotics
- written informed consent
- Exclusion Criteria: Any of the following is regarded as a criterion for exclusion from enrollment in the study:
- Subjects currently enrolled in another clinical study
Show all 19Show fewer
- Subjects having finished another clinical study within the last 4 weeks before inclusion
- Diabetes mellitus
- Acute metabolic disorder interfering with glucose metabolism
- Known cancer < 5y ago
- Any ano-rectal infection, disease, surgery in the medical history or current which may have impact on microbiota
- Anus praeter
- Hypersensitivity, allergy or idiosyncratic reaction to any component of the test product
- Any disease or condition which might significantly compromise the hematopoietic, renal, endocrine, pulmonary, hepatic, gastrointestinal, cardiovascular, immunological, central nervous, dermatological or any other body system
- History of active hepatitis B and C
- History of HIV infection
- Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.)
- Major cognitive or psychiatric disorders
- Present drug abuse or alcoholism, reformed alcoholic Legal incapacity
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinical Research Center Kiel GmbH
Kiel, Schleswig-Holstein, D-24118
About this study
Official title: Double Blind,Randomized, Controlled Trial on Impact of Oral Probiotic Blend ( Lactobacillus Rhamnosus GG, L. Crispatus LBV88, L. Rhamnosus LBV96, L.Jensenii LBV116 and L. Gasseri LBV150 ) on Pregnancy Outcome
The aim of this study is, to investigate the effect of oral intake of Lactobacillus rhamnosus GG (ATCC 53103), Lactobacillus crispatus Lbv88, Lactobacillus rhamnosus Lbv96, Lactobacillus jensenii Lbv116 Lactobacillus gasseri Lbv150 on outcomes of pregnancy and microbiota and their interrelation.
Read the detailed description
Pregnant women aged > 18 years in the < 14th week of pregnancy willing to consume the study product once daily starting the day after V1 until delivery, complying with inclusion and exclusion criteria will be enrolled in the study.
After enrollement subjects will be randomly and evenly assigned to one of the two test groups verum and placebo.
The study population will be recruited in a screening examination ( G1 ) by gynaecologists from Kiel area.
Primary target parameter of the study :
HOMA-IRa value in week 24-28 (V2), which is based on glucose and insulin measures during the second oral glucose tolerance test (OGTT)
Secondary target parameters :
HOMA-IR value in week 36-40 , Alteration (V2 - V1) Δ HOMA-IR, Alteration (V2 - V1) Δ QUICKI
- Being tested
- capsule containing a probiotic blend of 5 different Lactobacilli, capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capsule containing a probiotic blend of 5 different LactobacilliDietary supplement
Also called verum
n=81 women (verum) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.
capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.Other
Also called placebo
n=81 women (placebo) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.
| Study group | Role | What they receive |
|---|---|---|
| verum | Active comparator | probiotic bland with 5 different lactobacilli Receives: Dietary Supplement: capsule containing a probiotic blend of 5 different Lactobacilli |
| placebo | Placebo comparator | Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics. Receives: Other: capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA-IR value in week 24-28
HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance
Measured: measurement between 24-28 week of pregnancy
HOMA-IR value in week 36-40
HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance
Measured: measurement between 36-40 week of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start5 Apr 2018
- Primary completion20 Feb 2020
- Study completion12 Jun 2020
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 Gestational Diabetes Mellitus in PregnancyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- N=162 pregnant women were randomly assigned to one of the 2 interventions: verum (Lactobacilli) or placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- i-Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christiane Laue, MD, Principal investigator, Clinical Research Center Kiel GmbH, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009889
- Sponsor's protocol ID
- HSO-PregO-2018
- Status last verified
- Feb 2021
- First submitted
- 3 Jul 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Davidson SJ, Barrett HL, Price SA, Callaway LK, Dekker Nitert M. Probiotics for preventing gestational diabetes. Cochrane Database Syst Rev. 2021 Apr 19;4(4):CD009951. doi: 10.1002/14651858.CD009951.pub3.
PubMed 33870484
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind,Randomized, Controlled Trial on Impact of Oral Probiotic Blend ( Lactobacillus Rhamnosus GG, L. Crispatus LBV88, L. Rhamnosus LBV96, L.Jensenii LBV116 and L. Gasseri LBV150 ) on Pregnancy Outcome
- ClinicalTrials.gov ID
- NCT04009889
- Acronym / sponsor ID
- HSO-PregO-2018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- i-Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 5 Jul 2019 (actual)
- 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 aim of this study is, to investigate the effect of oral intake of Lactobacillus rhamnosus GG (ATCC 53103), Lactobacillus crispatus Lbv88, Lactobacillus rhamnosus Lbv96, Lactobacillus jensenii Lbv116 Lactobacillus gasseri Lbv150 on outcomes of pregnancy and microbiota and their interrelation.
Detailed description
Pregnant women aged > 18 years in the < 14th week of pregnancy willing to consume the study product once daily starting the day after V1 until delivery, complying with inclusion and exclusion criteria will be enrolled in the study.
After enrollement subjects will be randomly and evenly assigned to one of the two test groups verum and placebo.
The study population will be recruited in a screening examination ( G1 ) by gynaecologists from Kiel area.
Primary target parameter of the study :
HOMA-IRa value in week 24-28 (V2), which is based on glucose and insulin measures during the second oral glucose tolerance test (OGTT)
Secondary target parameters :
HOMA-IR value in week 36-40 , Alteration (V2 - V1) Δ HOMA-IR, Alteration (V2 - V1) Δ QUICKI
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- N=162 pregnant women were randomly assigned to one of the 2 interventions: verum (Lactobacilli) or placebo
| Arm | Type | Receives |
|---|---|---|
| verum | Active comparator | Dietary Supplement: capsule containing a probiotic blend of 5 different Lactobacilliprobiotic bland with 5 different lactobacilli |
| placebo | Placebo comparator | Other: capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- pregnant women aged > 18 years in the < 14 week of pregnancy
- willing to consume the study product during pregnancy ( V1 to delivery)
- willingness to abstain from probiotic food and supplements containing probiotics
- written informed consent
- Exclusion Criteria: Any of the following is regarded as a criterion for exclusion from enrollment in the study:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| capsule containing a probiotic blend of 5 different LactobacilliAlso: verumn=81 women (verum) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery. | Dietary supplement | verum |
| capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.Also: placebon=81 women (placebo) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery. | Other | placebo |
Primary outcome
HOMA-IR value in week 24-28
Time frame: measurement between 24-28 week of pregnancy
HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance
HOMA-IR value in week 36-40
Time frame: measurement between 36-40 week of pregnancy
HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance
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 9 Feb 2021.
- Derived from this study: PubMed 33870484Davidson SJ, Barrett HL, Price SA, Callaway LK, Dekker Nitert M. Probiotics for preventing gestational diabetes. Cochrane Database Syst Rev. 2021 Apr 19;4(4):CD009951. doi: 10.1002/14651858.CD009951.pub3.
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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.
Christiane Laue, MD principal investigator
Clinical Research Center Kiel GmbH, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capsule containing a probiotic blend of 5 different Lactobacilli and capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics. in people with Gestational Diabetes Mellitus in Pregnancy, run by i-Health, Inc. at 1 site in Germany.
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 19 inclusion and 0 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 9 Feb 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 Germany. 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?
HOMA-IR value in week 24-28 (time frame: measurement between 24-28 week of pregnancy). The study lists 2 primary outcomes in all. 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 NCT04009889, 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 9 Feb 2021.