Impact of Oral Probiotic Blend on Pregnancy Outcome

i-Health

Status: Completed

Conditions: Gestational Diabetes Mellitus in Pregnancy

Treatments: Dietary Supplement: capsule containing a probiotic blend of 5 different Lactobacilli; Other: capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.

Study type: Interventional

Funder types: Industry

Identifiers

NCT04009889

HSO-PregO-2018

Details and patient eligibility

About

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.

Full 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

Enrollment: 170 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups, including a placebo group

verum

Active Comparator group

Description:

probiotic bland with 5 different lactobacilli

Treatment:

Dietary Supplement: capsule containing a probiotic blend of 5 different Lactobacilli

placebo

Placebo Comparator group

Description:

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

Treatment:

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