An interventional study of Postbiotic Supplement and Placebo in Gastrointestinal Health, sponsored by Federico II University. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Federico II University · Not applicable, Interventional, and Other
This study aimed to evaluate whether daily postbiotic supplementation could improve gastrointestinal well-being and influence physiological and metabolic parameters in healthy young adults.
A total of 22 healthy adults participated in this single-center, randomized, placebo-controlled pilot study. Participants were assigned to receive either a daily capsule containing 100 mg of a postbiotic preparation or a placebo for 12 weeks.
Gastrointestinal symptoms were assessed using the Gastrointestinal Symptom Rating Scale (GSRS) before and after supplementation. Additional assessments included body composition, metabolic health, intestinal microbiota, inflammation, oxidative stress, and quality of life.
The study was designed to explore the potential beneficial effects of postbiotic supplementation on gastrointestinal health and related biological processes.
The intestinal microbiota plays an important role in gastrointestinal homeostasis, metabolic regulation, immune function, and intestinal barrier integrity. Postbiotics, defined as preparations of inanimate microorganisms and/or their components that confer a health benefit, represent a potential nutritional strategy to support gastrointestinal health and modulate metabolic and inflammatory processes.
PIProBaTo II was designed as a single-center, randomized, participant-blinded, placebo-controlled pilot study to investigate the effects of postbiotic supplementation on gastrointestinal well-being and selected physiological and metabolic parameters in healthy adults.
The original protocol planned to enroll 30 healthy volunteers aged 18-28 years. A total of 22 participants were ultimately enrolled and randomized into two parallel groups: an intervention group receiving 100 mg/day of a postbiotic preparation containing inactivated Lacticaseibacillus paracasei NPB01 and Lacticaseibacillus rhamnosus GG (1 × 10¹⁰ CFU equivalents), and a control group receiving a placebo capsule with comparable organoleptic characteristics. Supplementation lasted 12 weeks.
Participants underwent assessments at baseline (T0) and after 12 weeks of intervention (T1).
The primary objective was to assess changes in gastrointestinal well-being using the Gastrointestinal Symptom Rating Scale (GSRS).
Secondary objectives included the evaluation of anthropometric parameters and body composition by bioelectrical impedance analysis (BIA), blood pressure, glucose and lipid metabolism, intestinal microbiota composition and function, intestinal barrier integrity, inflammatory and oxidative stress biomarkers, advanced glycation end products (AGEs), soluble receptor for AGEs (sRAGE), appetite regulation, and quality-of-life-related parameters.
Blood and stool samples were collected for planned biochemical and molecular investigations, including microbiome and metabolomic analyses. Additional exploratory assessments included markers related to mitochondrial metabolism and biological aging.
Adherence to supplementation and product tolerability were assessed throughout the intervention, including daily adherence records and the assessment of remaining capsules at the final visit.
The study aimed to provide preliminary evidence regarding the potential effects of postbiotic supplementation on gastrointestinal health and associated metabolic and inflammatory pathways, supporting the design of future clinical investigations.
Federico II University is the lead sponsor of 365 studies on the registry; 60 are open to participants now.
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Participants assigned to this arm received one capsule daily containing 100 mg of a postbiotic preparation composed of inactivated Lacticaseibacillus paracasei NPB01 and Lacticaseibacillus rhamnosus GG (1 × 10¹⁰ CFU equivalents) for 12 weeks.
Dietary Supplement: Postbiotic Supplement
Participants assigned to this arm received one placebo capsule daily without the postbiotic preparation for 12 weeks. The placebo capsules had organoleptic characteristics identical to those of the active supplement to maintain participant blinding.
Dietary Supplement: Placebo
A standardized postbiotic preparation containing 100 mg of inactivated Lacticaseibacillus paracasei NPB01 and Lacticaseibacillus rhamnosus GG (1 × 10¹⁰ CFU equivalents), administered orally as one capsule daily for 12 weeks.
An orally administered placebo capsule without the postbiotic preparation, matched to the active supplement in organoleptic characteristics. Participants received one capsule daily for 12 weeks.
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score
The Gastrointestinal Symptom Rating Scale (GSRS) is a validated 15-item questionnaire assessing five gastrointestinal symptom domains: abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item is scored on a 7-point Likert scale (1 = no symptoms; 7 = very severe symptoms), with higher scores indicating greater symptom severity. Changes in gastrointestinal symptoms are assessed from baseline (T0) to week 12 (T1).
Time frame: Baseline (T0) and Week 12 (T1)
Change in Gastrointestinal Quality of Life Index (GIQLI) Total Score
Change in gastrointestinal-related quality of life assessed using the 36-item Gastrointestinal Quality of Life Index (GIQLI). Total scores range from 0 to 144, with higher scores indicating better quality of life.
Time frame: Baseline (T0) and Week 12 (T1)
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score
Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Global scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Baseline (T0) and Week 12 (T1)
Change in Dietary Intake and Ultra-Processed Foods Consumption
Dietary intake was assessed using 7-day food diaries collected at baseline and week 12. Nutritional analysis includes daily energy and macronutrient intake, the percentage of total energy intake derived from ultra-processed foods (UPFs) according to the NOVA classification, and estimated dietary advanced glycation end product (AGE) intake.
Time frame: Baseline (T0) and Week 12 (T1)
Change in Body Composition Assessed by Bioelectrical Impedance Analysis
Body composition was assessed at baseline and week 12 using phase-sensitive bioelectrical impedance analysis (BIA 101, Akern). Measurements include fat mass, fat-free mass, phase angle, and body water compartments. Anthropometric parameters, including body weight and body mass index (BMI), were also evaluated.
Time frame: Baseline (T0) and Week 12 (T1)
Change in Skin Autofluorescence (SAF)
Skin autofluorescence (SAF), a non-invasive marker of tissue advanced glycation end product (AGE) accumulation, was measured using the AGE Reader (DiagnOptics Technologies). Measurements were performed at baseline and after 12 weeks of supplementation.
Time frame: Baseline (T0) and Week 12 (T1)
Change in Gut Microbiome Composition and Function
Fecal samples collected at baseline and week 12 will undergo shotgun metagenomic sequencing to characterize gut microbial composition and functional potential. Metabolomic analyses will be performed to evaluate changes in microbial metabolites, including short-chain fatty acids such as acetate, propionate, and butyrate, following postbiotic supplementation.
Time frame: Baseline (T0) and Week 12 (T1)
Change in Blood Biochemical Profile
Changes in fasting blood biochemical parameters, including glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides, will be assessed at baseline and after 12 weeks of supplementation using automated enzymatic laboratory methods (mg/dL).
Time frame: Baseline (T0) and Week 12 (T1)
Change in Fasting Insulin Levels
Fasting insulin concentrations will be determined using a high-sensitivity enzyme-linked immunosorbent assay (ELISA) (µIU/mL). Changes will be assessed between baseline and Week 12.
Time frame: Baseline (T0) and Week 12 (T1)
Change in Testosterone Levels
Circulating testosterone concentrations will be assessed at baseline and after 12 weeks of supplementation (ng/dL).
Time frame: Baseline (T0) and Week 12 (T1)
Change in Estradiol Levels
Circulating estradiol concentrations will be assessed at baseline and after 12 weeks of supplementation (pg/mL).
Time frame: Baseline (T0) and Week 12 (T1)
Change in Sex Hormone-Binding Globulin (SHBG) Levels
Circulating sex hormone-binding globulin concentrations will be assessed at baseline and after 12 weeks of supplementation (nmol/L).
Time frame: Baseline (T0) and Week 12 (T1)
Change in Inflammatory Cytokine Profile
Changes in circulating inflammatory cytokines, including IL-2, IL-4, IL-6, IL-8, IL-10, IL-1β, TNF-α, and IFN-γ, will be assessed at baseline and after 12 weeks of supplementation using multiplex Luminex immunoassays (pg/mL).
Time frame: Baseline (T0) and Week 12 (T1)
Change in Incretin Profile
Changes in circulating glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) concentrations will be assessed at baseline and after 12 weeks of supplementation using specific enzyme-linked immunosorbent assays (ELISA).
Time frame: Baseline (T0) and Week 12 (T1)
Change in Serum Zonulin Levels
Serum zonulin concentrations will be assessed at baseline and after 12 weeks of supplementation using an enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline (T0) and Week 12 (T1)
Change in Soluble Receptor for Advanced Glycation End Products (sRAGE) Levels
Plasma soluble receptor for advanced glycation end products (sRAGE) concentrations will be assessed at baseline and after 12 weeks of supplementation using an enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline (T0) and Week 12 (T1)
Change in Plasma N-Acylethanolamine Profile
Changes in circulating N-acylethanolamines, including anandamide (AEA), oleoylethanolamide (OEA), and palmitoylethanolamide (PEA), will be assessed at baseline and after 12 weeks of supplementation using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).
Time frame: Baseline (T0) and Week 12 (T1)
Change in Epigenetic Age Ratio
Changes in the epigenetic age ratio (ER) comparing baseline (T0) and after 12 weeks of supplementation (T1), assessed through DNA methylation profiling using the Illumina Infinium MethylationEPIC array and the Horvath Skin \& Blood epigenetic clock. ER will be calculated as \[(epigenetic age - chronological age) / chronological age\] × 100 and expressed as a percentage (%).
Time frame: Baseline (T0) and Week 12 (T1)
Change in PBMC Gene Expression
Changes in gene expression related to cellular redox pathways in peripheral blood mononuclear cells (PBMCs), comparing baseline (T0) and after 12 weeks of supplementation (T1), assessed using reverse transcription quantitative polymerase chain reaction (RT-qPCR).
Time frame: Baseline (T0) and Week 12 (T1)
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