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Impact of Oral Probiotic Blend on Pregnancy Outcome

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ClinicalTrials.gov Identifier: NCT04009889
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
i-Health, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus in Pregnancy Dietary Supplement: capsule containing a probiotic blend of 5 different Lactobacilli Other: capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics. Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: N=162 pregnant women were randomly assigned to one of the 2 interventions: verum (Lactobacilli) or placebo
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : March 27, 2018
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: verum
probiotic bland with 5 different lactobacilli
Dietary Supplement: capsule containing a probiotic blend of 5 different Lactobacilli
n=81 women (verum) starts befor end of pregnancy week 14 with consumption of 1 capsule daily until delivery.
Other Name: verum

Placebo Comparator: placebo
Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.
Other: capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.
n=81 women (placebo) starts befor end of pregnancy week 14 with consumption of 1 capsule daily until delivery.
Other Name: placebo




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women aged > 18 years in the < 14 week of pregnancy
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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:

  1. Subjects currently enrolled in another clinical study
  2. Subjects having finished another clinical study within the last 4 weeks before inclusion
  3. Diabetes mellitus
  4. Acute metabolic disorder interfering with glucose metabolism
  5. Known cancer < 5y ago
  6. Any ano-rectal infection, disease, surgery in the medical history or current which may have impact on microbiota
  7. Anus praeter
  8. Hypersensitivity, allergy or idiosyncratic reaction to any component of the test product
  9. 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
  10. History of active hepatitis B and C
  11. History of HIV infection
  12. Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.)
  13. Major cognitive or psychiatric disorders
  14. Present drug abuse or alcoholism, reformed alcoholic Legal incapacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04009889


Contacts
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Contact: Seema Mody +1(860)894-1200 mody@dsm.com
Contact: Linnerth Barbara, PhD +43/1/2350780 linnerth@HSO.at

Locations
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Germany
Clinical Research Center Kiel GmbH Recruiting
Kiel, Schleswig-Holstein, Germany, D-24118
Contact: Christiane Laue, MD    +49 431 5606 ext 599    c.laue@crc-kiel.de   
Contact: Angelika Pannenbeckers, MD    +49 431 5606 ext 870    a.pannenbeckers@crc-kiel.de   
Sponsors and Collaborators
i-Health, Inc.
Investigators
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Principal Investigator: Christiane Laue, MD Clinical Research Center Kiel GmbH, Germany

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Responsible Party: i-Health, Inc.
ClinicalTrials.gov Identifier: NCT04009889     History of Changes
Other Study ID Numbers: HSO-PregO-2018
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy in Diabetics
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Silicon
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs