Impact of Oral Probiotic Blend on Pregnancy Outcome

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04009889
• Other study ID #: HSO-PregO-2018
• Status: Completed
• Phase: N/A
• Start date: April 5, 2018
• Est. completion date: June 12, 2020

Study information

• Verified date: February 2021
• Source: i-Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: June 12, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

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:
• 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.

Locations

Country	Name	City	State
Germany	Clinical Research Center Kiel GmbH	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
i-Health, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HOMA-IR value in week 24-28	HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance	measurement between 24-28 week of pregnancy
Primary	HOMA-IR value in week 36-40	HOMA -IR is the product of insulin x glucose and describes the level of insulin resistance	measurement between 36-40 week of pregnancy