Gastrointestinal HealthPIProBaTo-IINCT07893301
The Impact of Postbiotic Supplementation on Tolerability and Physiological/Metabolic Parameters
A study testing Postbiotic Supplement in people with Gastrointestinal Health, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Health
- What is being tested?
- Postbiotic Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jun 2026to 28 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers aged 18-28 years.
- Provision of written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Capsule Postbiotic Supplementation on Physiological and Metabolic Parameters and Dietary Tolerability in Healthy Volunteers
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Gastrointestinal Health
- Being tested
- Postbiotic Supplement, Placebo
- Keywords
- Postbiotics, Gastrointestinal Symptoms, Gut Microbiota, Dietary Supplementation, Intestinal Barrier Function, Metabolic Health, Healthy Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postbiotic SupplementDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (T0) and Week 12 (T1)
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: 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).
Measured: Baseline (T0) and Week 12 (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start22 Jun 2026
- Primary completion28 Sep 2026
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HealthStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
- Investigators
- Roberto Berni Canani, MD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893301
- Sponsor's protocol ID
- 188/26
- Acronym
- PIProBaTo-II
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Capsule Postbiotic Supplementation on Physiological and Metabolic Parameters and Dietary Tolerability in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07893301
- Acronym / sponsor ID
- PIProBaTo-II / 188/26
- Conditions
- Gastrointestinal Health
- Keywords
- Postbiotics, Gastrointestinal Symptoms, Gut Microbiota, Dietary Supplementation, Intestinal Barrier Function, Metabolic Health, Healthy Adults
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 28 Oct 2026 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Postbiotic Supplementation | Experimental | Dietary Supplement: Postbiotic SupplementParticipants 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female volunteers aged 18-28 years.
- Provision of written informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postbiotic SupplementA 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. | Dietary supplement | Postbiotic Supplementation |
| PlaceboAn orally administered placebo capsule without the postbiotic preparation, matched to the active supplement in organoleptic characteristics. Participants received one capsule daily for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score
Time frame: Baseline (T0) and Week 12 (T1)
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).
18 secondary outcomes
Change in Gastrointestinal Quality of Life Index (GIQLI) Total Score
Time frame: Baseline (T0) and Week 12 (T1)
Change in Pittsburgh Sleep Quality Index (PSQI) Global Score
Time frame: Baseline (T0) and Week 12 (T1)
Change in Dietary Intake and Ultra-Processed Foods Consumption
Time frame: Baseline (T0) and Week 12 (T1)
Change in Body Composition Assessed by Bioelectrical Impedance Analysis
Time frame: Baseline (T0) and Week 12 (T1)
Change in Skin Autofluorescence (SAF)
Time frame: Baseline (T0) and Week 12 (T1)
Change in Gut Microbiome Composition and Function
Time frame: Baseline (T0) and Week 12 (T1)
Change in Blood Biochemical Profile
Time frame: Baseline (T0) and Week 12 (T1)
Change in Fasting Insulin Levels
Time frame: Baseline (T0) and Week 12 (T1)
Change in Testosterone Levels
Time frame: Baseline (T0) and Week 12 (T1)
Change in Estradiol Levels
Time frame: Baseline (T0) and Week 12 (T1)
Change in Sex Hormone-Binding Globulin (SHBG) Levels
Time frame: Baseline (T0) and Week 12 (T1)
Change in Inflammatory Cytokine Profile
Time frame: Baseline (T0) and Week 12 (T1)
Change in Incretin Profile
Time frame: Baseline (T0) and Week 12 (T1)
Change in Serum Zonulin Levels
Time frame: Baseline (T0) and Week 12 (T1)
Change in Soluble Receptor for Advanced Glycation End Products (sRAGE) Levels
Time frame: Baseline (T0) and Week 12 (T1)
Change in Plasma N-Acylethanolamine Profile
Time frame: Baseline (T0) and Week 12 (T1)
Change in Epigenetic Age Ratio
Time frame: Baseline (T0) and Week 12 (T1)
Change in PBMC Gene Expression
Time frame: Baseline (T0) and Week 12 (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Berni Canani, MD principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postbiotic Supplement in people with Gastrointestinal Health, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score (time frame: Baseline (T0) and Week 12 (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.