Influence of probiotics on inflammatory parameters and microbiome diversity in bariatric patients: pre- and postoperative

Influence of probiotics on inflammatory parameters and microbiome diversity in bariatric patients: pre- and postoperative - MikroBar

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031550

Enrollment

Registered

2023-05-04

Start date

2023-05-08

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E66

Interventions

Group 1: Intervention group (bariatric patients with sleeve gastrectomy): Multispecies probiotic OMNiBiOTiC® HETOX (Institute AllergoSan), 4 weeks pre- and 12 weeks postoperative, including the standa

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Planned bariatric surgery (sleeve gastrectomy) at the SRH Wald-Klinikum Gera BMI = 30.0 kg/m² ECOG performance status: 0-1

Exclusion criteria

Exclusion criteria: Bariatric surgery already performed Sleeve gastrectomy not performed Presence or suspicion of malignant neoplasia Severe underlying diseases (e.g. renal insufficiency, liver cirrhosis, etc.) Chronic inflammatory diseases (e.g. rheumatoid arthritis, crohn's disease, ulcerative colitis, etc.) Severe dementia syndrome (Mini-Mental Status Examination 14 days Immunosuppressive therapy Chronic oral intake of glucocorticoids

Design outcomes

Primary

Measure	Time frame
Inflammatory profile (leukocytes, C-reactive protein (CRP), fibrinogen - blood sampling) of the patients - collection of data: basal, after 4 weeks (preoperative) and after 16 weeks (12 weeks postoperative) of probiotic administration	—

Secondary

Measure	Time frame
Microbiome diversity (stool sample - 16S rRNA gene sequencing) Weight loss (measurement of body weight and height): body weight (kg), weight loss (kg; %), BMI (kg/m²), excess weight loss (%EWL) Body composition (bioelectrical impedance analysis): skeletal muscle mass (SMM: kg; %), fat mass (FM: kg; %), fat mass index (FMI: kg/m²), fat-free mass (FFM: kg; %), fat-free mass index (FFMI: kg/m²), total body water (TBW: l; %), extracellular water (ECW: l; %), resistance (Ohm), reactance (Ohm) Phase angle (°) (bioelectrical impedance analysis) Glucose balance (blood sampling): fasting glucose (mmol/l), HbA1c (%) Lipid metabolism (blood sampling): total cholesterol (mmol/l), low-density lipoprotein (mmol/l), high-density lipoprotein (mmol/l), triglycerides (mmol/l) Liver parameters (blood sampling): aspartate aminotransferase (ASAT: U/L), alanine aminotransferase (ALAT: U/L), alkaline phosphatase (AP: U/L), glutamate dehydrogenase (GLDH: U/L), bilirubin (mg/dl) Other biochemical parameters (blood sampling): small blood count, creatinine (mg/dl), lipase (U/l), zinc (µg/dl) Thyroid parameters (blood sampling): thyroid-stimulating hormone (TSH; mU/l), free triiodothyronine (fT3; pmol/l), free thyroxine (fT4; pmol/l) Lipidomics (blood sampling; shotgun lipidomics) Diet and nutritional quality (food frequency questionnaire (DEGS-FFQ)) Quality of life (StuDoQ obesity quality of life questionnaire (BQL)) Physical activity: METs (min/d) (International Physical Activity Questionnaire - short form) Data collection of all secondary endpoints: basal, after 4-week (preoperative) and after 16-week (postoperative) of probiotic administration	—

Measure

Time frame

Microbiome diversity (stool sample - 16S rRNA gene sequencing) Weight loss (measurement of body weight and height): body weight (kg), weight loss (kg; %), BMI (kg/m²), excess weight loss (%EWL) Body composition (bioelectrical impedance analysis): skeletal muscle mass (SMM: kg; %), fat mass (FM: kg; %), fat mass index (FMI: kg/m²), fat-free mass (FFM: kg; %), fat-free mass index (FFMI: kg/m²), total body water (TBW: l; %), extracellular water (ECW: l; %), resistance (Ohm), reactance (Ohm) Phase angle (°) (bioelectrical impedance analysis) Glucose balance (blood sampling): fasting glucose (mmol/l), HbA1c (%) Lipid metabolism (blood sampling): total cholesterol (mmol/l), low-density lipoprotein (mmol/l), high-density lipoprotein (mmol/l), triglycerides (mmol/l) Liver parameters (blood sampling): aspartate aminotransferase (ASAT: U/L), alanine aminotransferase (ALAT: U/L), alkaline phosphatase (AP: U/L), glutamate dehydrogenase (GLDH: U/L), bilirubin (mg/dl) Other biochemical parameters (blood sampling): small blood count, creatinine (mg/dl), lipase (U/l), zinc (µg/dl) Thyroid parameters (blood sampling): thyroid-stimulating hormone (TSH; mU/l), free triiodothyronine (fT3; pmol/l), free thyroxine (fT4; pmol/l) Lipidomics (blood sampling; shotgun lipidomics) Diet and nutritional quality (food frequency questionnaire (DEGS-FFQ)) Quality of life (StuDoQ obesity quality of life questionnaire (BQL)) Physical activity: METs (min/d) (International Physical Activity Questionnaire - short form) Data collection of all secondary endpoints: basal, after 4-week (preoperative) and after 16-week (postoperative) of probiotic administration

—

Countries

Germany

Contacts

Public ContactDorothea Portius

SRH University Campus Gera

dorothea.portius@landw.uni-halle.de+49 365 773407-19

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026