The Impact of Postbiotic Supplementation on Tolerability and Physiological/Metabolic Parameters

NCT07893301 | Active Not Recruiting

• 1 other identifier: 188/26
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Health

Keywords

Postbiotics; Gastrointestinal Symptoms; Gut Microbiota; Dietary Supplementation; Intestinal Barrier Function; Metabolic Health; Healthy Adults

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline (T0) and Week 12 (T1)

Secondary Outcomes (18)

• Change in Gastrointestinal Quality of Life Index (GIQLI) Total Score

  Baseline (T0) and Week 12 (T1)

• Change in Pittsburgh Sleep Quality Index (PSQI) Global Score

  Baseline (T0) and Week 12 (T1)

• Change in Dietary Intake and Ultra-Processed Foods Consumption

  Baseline (T0) and Week 12 (T1)

• Change in Body Composition Assessed by Bioelectrical Impedance Analysis

  Baseline (T0) and Week 12 (T1)

• Change in Skin Autofluorescence (SAF)

  Baseline (T0) and Week 12 (T1)

Study Arms (2)

Postbiotic Supplementation

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Postbiotic Supplement DIETARY_SUPPLEMENT

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.

Postbiotic Supplementation

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female volunteers aged 18-28 years.
• Provision of written informed consent.

You may not qualify if:

• Age below 18 years or above 28 years.
• History of chronic diseases, including overweight or obesity, cardiovascular diseases, cancer, dyslipidemia, allergic or autoimmune diseases, genetic or metabolic disorders, neurological or neuropsychiatric diseases, chronic infections, bone diseases, gastrointestinal or respiratory diseases, and renal or hepatic diseases.
• Use of medications within the two weeks preceding study enrollment.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

Location

Study Officials

• Roberto Berni Canani, MD

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to treatment allocation. The postbiotic and placebo capsules had identical organoleptic characteristics to maintain participant blinding. Investigators were aware of treatment allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Pediatrics

Model Details: This is a single-center, randomized, participant-blinded, placebo-controlled pilot study with two parallel arms. A total of 22 healthy adult participants were assigned to receive either a postbiotic supplement or a placebo for 12 weeks. Study assessments were performed at baseline (T0) and after 12 weeks of intervention (T12). The primary objective was to evaluate changes in gastrointestinal well-being using the Gastrointestinal Symptom Rating Scale (GSRS).

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 23, 2026
• Study Start: June 22, 2026
• Primary Completion: September 28, 2026
• Study Completion (Estimated): October 28, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)