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Impact of Oral Probiotic Blend on Pregnancy Outcome

Primary Purpose

Gestational Diabetes Mellitus in Pregnancy

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

capsule containing a probiotic blend of 5 different Lactobacilli

capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.

About this trial

This is an interventional prevention trial for Gestational Diabetes Mellitus in Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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:

Subjects currently enrolled in another clinical study
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

Sites / Locations

Clinical Research Center Kiel GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

verum

placebo

Arm Description

probiotic bland with 5 different lactobacilli

Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.

Outcomes

Primary Outcome Measures

HOMA-IR value in week 24-28

HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance

HOMA-IR value in week 36-40

HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance

Secondary Outcome Measures

Full Information

NCT ID

NCT04009889

First Posted

July 3, 2019

Last Updated

February 5, 2021

Sponsor

i-Health, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04009889

Brief Title

Impact of Oral Probiotic Blend on Pregnancy Outcome

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

April 5, 2018 (Actual)

Primary Completion Date

February 20, 2020 (Actual)

Study Completion Date

June 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

i-Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gestational Diabetes Mellitus in Pregnancy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

N=162 pregnant women were randomly assigned to one of the 2 interventions: verum (Lactobacilli) or placebo

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

170 (Actual)

8. Arms, Groups, and Interventions

Arm Title

verum

Arm Type

Active Comparator

Arm Description

probiotic bland with 5 different lactobacilli

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.

Intervention Type

Dietary Supplement

Intervention Name(s)

capsule containing a probiotic blend of 5 different Lactobacilli

Other Intervention Name(s)

verum

Intervention Description

n=81 women (verum) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.

Intervention Type

Other

Intervention Name(s)

capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.

Other Intervention Name(s)

placebo

Intervention Description

n=81 women (placebo) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.

Primary Outcome Measure Information:

Title

HOMA-IR value in week 24-28

Description

HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance

Time Frame

measurement between 24-28 week of pregnancy

Title

HOMA-IR value in week 36-40

Description

HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance

Time Frame

measurement between 36-40 week of pregnancy

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

pregnant women aged > 18 years in the < 14 week of pregnancy

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: Subjects currently enrolled in another clinical study 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christiane Laue, MD

Organizational Affiliation

Clinical Research Center Kiel GmbH, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Research Center Kiel GmbH

City

Kiel

State/Province

Schleswig-Holstein

ZIP/Postal Code

D-24118

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

33870484

Citation

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.

Results Reference

derived

Learn more about this trial

Impact of Oral Probiotic Blend on Pregnancy Outcome

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