SIBODCP-PCT-EPINCT07479238
Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy
An observational study of SIBO and Pancreatic Insufficiency, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Pancreatic exocrine insufficiency (PEI) results from reduced pancreatic enzyme secretion, leading to malabsorption, malnutrition, and impaired quality of life. Although pancreatic enzyme replacement therapy (PERT) is the standard treatment, some patients remain symptomatic despite apparently adequate therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SIBO, Pancreatic Insufficiency, Chronic Pancreatitis
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2026to 26 Apr 2028
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (≥18 years) with pancreatic exocrine insufficiency (PEI) attending a tertiary referral center. Eligible participants include: 1. patients with chronic pancreatitis and documented PEI, and 2. patients who underwent partial pancreatectomy for ampullary or pancreatic tumors and subsequently developed PEI. All participants present with persistent gastrointestinal symptoms and are undergoing evaluation with glucose, lactulose, and mixed triglyceride breath tests as part of routine clinical practice to investigate pancreatic exocrine function and the presence of small intestinal bacterial overgrowth (SIBO).
Who may be able to join
- Age ≥ 18 years
- Ability and willingness to participate in the study and to comply with study procedures
- Diagnosis of chronic pancreatitis with pancreatic exocrine insufficiency (defined as fecal elastase < 200 µg/g of stool)
- Ongoing pancreatic enzyme replacement therapy (PERT) with persistent gastrointestinal symptoms (including abdominal pain, dyspepsia, bloating, excessive flatulence, diarrhea, or steatorrhea) or unintentional weight loss ≥ 10% within the previous 6 months despite adequate PERT dosing (≥ 40,000 IU per main meal and half dose for snacks)
- Patients with ampullary or pancreatic tumors who underwent partial pancreatectomy and subsequently developed pancreatic exocrine insufficiency with persistent gastrointestinal symptoms
- Indication to undergo glucose, lactulose, and mixed triglyceride breath tests as part of routine clinical practice
- Signed written informed consent
Who cannot join
- Age < 18 years or > 75 years
- Pancreatic adenocarcinoma or bile duct tumors under active or previous adjuvant therapy
- Moderate to severe liver disease
- Severe chronic kidney disease (eGFR < 30 mL/min/1.73 m²)
- History of major gastrointestinal surgery, including total pancreatectomy
- Presence of other active organic gastrointestinal diseases
Show all 16Show fewer
- Diabetic gastroparesis
- Known celiac disease
- Obstructive jaundice
- Liver cirrhosis Child-Pugh class C
- Recent or ongoing infections
- Severe chronic obstructive pulmonary disease (COPD)
- Symptomatic thyroid disorders
- Use of antibiotics, laxatives, probiotics, or prokinetic agents within 4 weeks prior to breath testing
- Inability or refusal to undergo study procedures
- Inability or refusal to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sara Sofia De Lucia contact
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, 00168
Enrico Celestino Nista, +39 3298973569, enricocelestino.nista@policlinicogemelli.it
Sara Sofia De Lucia
About this study
Official title: Prevalence of SIBO in Patients With Chronic Pancreatitis and After Partial Pancreatectomy: Assessment by Glucose, Lactulose and Mixed Triglyceride Breath Tests.
Pancreatic exocrine insufficiency (PEI) results from reduced pancreatic enzyme secretion, leading to malabsorption, malnutrition, and impaired quality of life. Although pancreatic enzyme replacement therapy (PERT) is the standard treatment, some patients remain symptomatic despite apparently adequate therapy. Possible causes include suboptimal dosing or concomitant conditions such as small intestinal bacterial overgrowth (SIBO). This study aims to determine the prevalence of SIBO in symptomatic PEI patients despite adequate PERT and to identify treatable causes of persistent symptoms using non-invasive diagnostic tests, with the goal of improving nutritional status and quality of life.
Read the detailed description
Pancreatic exocrine insufficiency (PEI) is defined as a reduction in pancreatic exocrine secretion below the level required for normal digestion of nutrients, leading to malabsorption, malnutrition, reduced quality of life, and increased morbidity. Chronic pancreatitis represents the most common cause of PEI, although the condition may also develop after pancreaticoduodenectomy.
Pancreatic enzyme replacement therapy (PERT) with pancrelipase is the standard treatment and is effective in most patients. However, a proportion of individuals continue to experience gastrointestinal symptoms and weight loss despite apparently adequate therapy, possibly due to suboptimal dosing or concomitant conditions such as small intestinal bacterial overgrowth (SIBO). The mixed triglyceride breath test may help evaluate the adequacy of enzyme replacement therapy, while non-invasive breath tests using glucose or lactulose represent practical diagnostic alternatives for SIBO.
This study aims to determine the prevalence of SIBO in patients with PEI who remain symptomatic despite adequate PERT and to identify treatable causes of persistent gastrointestinal symptoms and malnutrition through non-invasive diagnostic tests, with the ultimate goal of improving patients' nutritional status and quality of life.
- Keywords
- Pancreatic exocrine insufficiency, Chronic pancreatitis, enzyme replacement therapy, Small intestinal bacterial overgrowth
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Pancreatitis, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO)
Assessment of the prevalence of SIBO among two patient groups:
- individuals with chronic pancreatitis and pancreatic exocrine insufficiency (PEI), and
- patients who underwent partial pancreatectomy and subsequently developed PEI. SIBO will be diagnosed using glucose and lactulose hydrogen breath tests according to international diagnostic criteria.
Measured: Baseline
Secondary outcomes (3)
Improvement of Gastrointestinal Symptoms After Antibiotic Treatment
Evaluation of reduction or resolution of gastrointestinal symptoms (including abdominal bloating, abdominal pain, diarrhea, excessive flatulence) following antibiotic therapy in participants diagnosed with SIBO.
Measured: Up to 3 months after treatment
Identification of Alternative Causes of Persistent Symptoms
Investigation of other potential causes of gastrointestinal symptoms in patients with negative breath tests, including undiagnosed celiac disease, sugar malabsorption, and irritable bowel syndrome, using appropriate diagnostic tests.
Measured: Baseline to 3 months
Comparison of Demographic, Clinical, and Laboratory Variables Between Patient Groups
Comparison of demographic (age, sex, BMI), clinical (disease duration, symptom severity), and laboratory parameters (e.g., inflammatory markers, pancreatic enzyme markers) between:
- patients with SIBO, and
- patients with a positive mixed triglyceride breath test indicating impaired pancreatic exocrine function.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion26 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SIBOStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nista Enrico Celestino, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Enrico Celestino Nista, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479238
- Sponsor's protocol ID
- 23363
- Acronym
- DCP-PCT-EPI
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of SIBO in Patients With Chronic Pancreatitis and After Partial Pancreatectomy: Assessment by Glucose, Lactulose and Mixed Triglyceride Breath Tests.
- ClinicalTrials.gov ID
- NCT07479238
- Acronym / sponsor ID
- DCP-PCT-EPI / 23363
- Keywords
- Pancreatic exocrine insufficiency, Chronic pancreatitis, enzyme replacement therapy, Small intestinal bacterial overgrowth
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 26 Apr 2028 (estimated)
- First posted
- 18 Mar 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.
Pancreatic exocrine insufficiency (PEI) results from reduced pancreatic enzyme secretion, leading to malabsorption, malnutrition, and impaired quality of life. Although pancreatic enzyme replacement therapy (PERT) is the standard treatment, some patients remain symptomatic despite apparently adequate therapy. Possible causes include suboptimal dosing or concomitant conditions such as small intestinal bacterial overgrowth (SIBO). This study aims to determine the prevalence of SIBO in symptomatic PEI patients despite adequate PERT and to identify treatable causes of persistent symptoms using non-invasive diagnostic tests, with the goal of improving nutritional status and quality of life.
Detailed description
Pancreatic exocrine insufficiency (PEI) is defined as a reduction in pancreatic exocrine secretion below the level required for normal digestion of nutrients, leading to malabsorption, malnutrition, reduced quality of life, and increased morbidity. Chronic pancreatitis represents the most common cause of PEI, although the condition may also develop after pancreaticoduodenectomy.
Pancreatic enzyme replacement therapy (PERT) with pancrelipase is the standard treatment and is effective in most patients. However, a proportion of individuals continue to experience gastrointestinal symptoms and weight loss despite apparently adequate therapy, possibly due to suboptimal dosing or concomitant conditions such as small intestinal bacterial overgrowth (SIBO). The mixed triglyceride breath test may help evaluate the adequacy of enzyme replacement therapy, while non-invasive breath tests using glucose or lactulose represent practical diagnostic alternatives for SIBO.
This study aims to determine the prevalence of SIBO in patients with PEI who remain symptomatic despite adequate PERT and to identify treatable causes of persistent gastrointestinal symptoms and malnutrition through non-invasive diagnostic tests, with the ultimate goal of improving patients' nutritional status and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (≥18 years) with pancreatic exocrine insufficiency (PEI) attending a tertiary referral center. Eligible participants include: 1. patients with chronic pancreatitis and documented PEI, and 2. patients who underwent partial pancreatectomy for ampullary or pancreatic tumors and subsequently developed PEI. All participants present with persistent gastrointestinal symptoms and are undergoing evaluation with glucose, lactulose, and mixed triglyceride breath tests as part of routine clinical practice to investigate pancreatic exocrine function and the presence of small intestinal bacterial overgrowth (SIBO).
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Ability and willingness to participate in the study and to comply with study procedures
- Diagnosis of chronic pancreatitis with pancreatic exocrine insufficiency (defined as fecal elastase < 200 µg/g of stool)
- Ongoing pancreatic enzyme replacement therapy (PERT) with persistent gastrointestinal symptoms (including abdominal pain, dyspepsia, bloating, excessive flatulence, diarrhea, or steatorrhea) or unintentional weight loss ≥ 10% within the previous 6 months despite adequate PERT dosing (≥ 40,000 IU per main meal and half dose for snacks)
- Patients with ampullary or pancreatic tumors who underwent partial pancreatectomy and subsequently developed pancreatic exocrine insufficiency with persistent gastrointestinal symptoms
Key exclusion criteria (16 listed)
- Age < 18 years or > 75 years
- Pancreatic adenocarcinoma or bile duct tumors under active or previous adjuvant therapy
- Moderate to severe liver disease
- Severe chronic kidney disease (eGFR < 30 mL/min/1.73 m²)
- History of major gastrointestinal surgery, including total pancreatectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO)
Time frame: Baseline
Assessment of the prevalence of SIBO among two patient groups: 1. individuals with chronic pancreatitis and pancreatic exocrine insufficiency (PEI), and 2. patients who underwent partial pancreatectomy and subsequently developed PEI. SIBO will be diagnosed using glucose and lactulose hydrogen breath tests according to international diagnostic criteria.
3 secondary outcomes
Improvement of Gastrointestinal Symptoms After Antibiotic Treatment
Time frame: Up to 3 months after treatment
Identification of Alternative Causes of Persistent Symptoms
Time frame: Baseline to 3 months
Comparison of Demographic, Clinical, and Laboratory Variables Between Patient Groups
Time frame: Baseline
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 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for SIBO
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
RecruitingObservational study
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis
Periodontitis (Stage 3), Periodontitis Stage IV
Enrolling by invitationPhase 2
Herbal Supplement (Biocidin REMOVE) for Bacterial Overgrowth in Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
RecruitingObservational study
Small Intestinal Bacterial Overgrowth (SIBO) in Pancreatic Adenocarcinoma (PDAC)
Pancreatic Adenocarcinoma, Weight Loss
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
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.
Sara Sofia De Lucia contact
Enrico Celestino Nista principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SIBO and Pancreatic Insufficiency, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 13 Apr 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. 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?
Contact Enrico Celestino Nista (+39 3298973569, enricocelestino.nista@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) (time frame: Baseline). 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 13 Apr 2026.