Impact of Oral Probiotic Blend on Pregnancy Outcome

February 5, 2021 updated by: i-Health, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, D-24118
        • Clinical Research Center Kiel GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.
Other Names:
  • 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 before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
measurement between 24-28 week of pregnancy
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
measurement between 36-40 week of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

i-Health, Inc.

Investigators

  • Principal Investigator: Christiane Laue, MD, Clinical Research Center Kiel GmbH, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 5, 2018

Primary Completion (ACTUAL)

February 20, 2020

Study Completion (ACTUAL)

June 12, 2020

Study Registration Dates

First Submitted

July 3, 2019

First Submitted That Met QC Criteria

July 3, 2019

First Posted (ACTUAL)

July 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 5, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSO-PregO-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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