Obese PatientsRYGB-MICROGUTNCT07381140
Bariatric Surgery and Gut Microbiota Changes Over Time
An observational study of Obese Patients and Obese Patients With Bariatric Surgery, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial summary
The goal of this observational study is to learn how bariatric surgery affects gut bacteria and gut-related metabolic products over time in adults with obesity. The study includes adults aged 18 to 65 years who are undergoing Roux-en-Y gastric bypass (RYGB) surgery, as well as adults with obesity treated with diet… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese Patients, Obese Patients With Bariatric Surgery, Gut Microbiota
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2026to 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obese subjects attending the clinical nutrition outpatient clinic of the IRCCS "Saverio de Bellis" - Castellana Grotte (BA).
Who may be able to join
- Age between 18 and 65 years.
- Adults with a body mass index (BMI) ≥ 35 kg/m² with related comorbidities, or BMI ≥ 40 kg/m², who are candidates for Roux-en-Y gastric bypass (RYGB) surgery only.
- Age between 18 and 65 years.
- Adults with BMI ≥ 30 kg/m² who are candidates for structured dietary treatment.
- Age between 18 and 65 years.
- Normal weight (BMI between 18.5 and 24.9 kg/m²).
Show all 17Show fewer
- Normal metabolic function: fasting glucose below threshold, normal ALT/AST, no diagnosis of diabetes or metabolic syndrome.
- No chronic gastrointestinal diseases or conditions that could alter the gut microbiota.
- Exclusion Criteria (Obese Control and Healthy Control Group):
- Use of antibiotics within the last 3 weeks or probiotics/prebiotics within the last 4-6 weeks.
- Recent gastrointestinal surgery.
- Pregnancy or breastfeeding.
- Extreme diets or recent dietary changes.
- Recent international travel that could have affected the gut microbiota.
- Medications known to influence the gut microbiota (e.g., PPIs, metformin, steroids).
- Active smoking or excessive alcohol consumption.
- Significant gastrointestinal symptoms (chronic diarrhea or constipation).
Who cannot join
- Treatment with antibiotics within the last 3 weeks, or probiotics/prebiotics within the last 4-6 weeks, or systemic corticosteroids within the 8 weeks prior to baseline (T0).
- Participation in dietary regimens or calorie restriction programs in the weeks prior to enrollment.
- Chronic inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis), ongoing enteric infections, or active neoplasms.
- Previous organ transplant or ongoing systemic immunosuppressive therapy.
- Pregnancy or breastfeeding.
- Previous major gastrointestinal surgery.
- Chronic alcohol consumption above moderate levels or substance use disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Castellana Grotte, BA, 70013
About this study
Official title: Longitudinal Evaluation of Gut Microbiota and Fecal Metabolome Following Roux-en-Y Gastric Bypass: Clinical Implications and Identification of Predictive Biomarkers
The goal of this observational study is to learn how bariatric surgery affects gut bacteria and gut-related metabolic products over time in adults with obesity. The study includes adults aged 18 to 65 years who are undergoing Roux-en-Y gastric bypass (RYGB) surgery, as well as adults with obesity treated with diet alone and healthy normal-weight adults.
The main questions it aims to answer are:
Read more
How does bariatric surgery change the composition and diversity of gut bacteria over time? How are these changes related to weight loss and improvement of obesity-related health conditions?
Researchers will compare people undergoing bariatric surgery with people with obesity treated with diet alone and with healthy normal-weight individuals to see if surgery leads to specific changes in gut bacteria and stool metabolites that are linked to better clinical outcomes.
Participants will:
Provide stool samples at scheduled time points over 12 months Provide blood samples and undergo routine clinical assessments Take part in follow-up visits to monitor weight, metabolic health, and gastrointestinal symptoms
Read the detailed description
Obesity is a complex and multifactorial condition associated with metabolic, inflammatory, and gastrointestinal alterations. In recent years, the gut microbiota has emerged as a key factor involved in energy balance, metabolic regulation, and systemic inflammation. Alterations in gut microbial composition and function have been consistently observed in individuals with obesity and are thought to contribute to metabolic dysfunction.
Bariatric surgery, particularly Roux-en-Y gastric bypass (RYGB), is one of the most effective treatments for severe obesity and its related comorbidities. Beyond weight loss, this procedure induces profound changes in gastrointestinal anatomy and nutrient flow, which may significantly influence the gut microbiota and the metabolites it produces. However, the timing, persistence, and clinical relevance of these microbial and metabolic changes over the long term are not yet fully understood.
This prospective observational study is designed to evaluate longitudinal changes in gut microbiota composition and fecal metabolome following bariatric surgery and to explore their association with clinical and metabolic outcomes. Participants undergoing bariatric surgery will be followed over a 12-month period and compared with individuals with obesity receiving dietary treatment and with healthy normal-weight individuals. This comparative approach allows the identification of changes specifically related to surgery rather than to weight loss alone or to normal temporal variability.
Gut microbiota will be analyzed using DNA-based sequencing approaches, while fecal metabolites will be assessed to capture functional changes in microbial activity. These biological data will be integrated with clinical and laboratory parameters to explore relationships between gut-related changes and outcomes such as weight loss, metabolic improvement, inflammation, and intestinal barrier function.
By providing a longitudinal and integrated view of gut microbiota and metabolome remodeling after bariatric surgery, this study aims to improve understanding of the biological mechanisms underlying surgical outcomes and to support the identification of potential biomarkers that may help predict individual responses and guide more personalized approaches to obesity management.
- Conditions
- Obese Patients, Obese Patients With Bariatric Surgery, Gut Microbiota, Healthy Participants
- Keywords
- gut microbiota, stool metabolome, obesity, bariatric surgery, Roux-en-Y gastric bypass, Long-read sequencing
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RYGB Group | Adults aged 18-65 years with severe obesity (BMI ≥ 35 kg/m² with comorbidities or BMI ≥ 40 kg/m²) who are undergoing Roux-en-Y gastric bypass (RYGB) surgery. | |
| Obese Control Group | Adults aged 18-65 years with obesity (BMI ≥ 30 kg/m²) who are receiving structured dietary treatment without surgery. | |
| Healthy Control Group | Adults aged 18-65 years with normal weight (BMI 18.5-24.9 kg/m²) and normal metabolic function. This group helps identify normal variations in gut bacteria and metabolites over time, independent of obesity or surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-Term Changes in Gut Microbiota After Bariatric Surgery
Longitudinal changes in the composition and diversity of the gut microbiota (alpha diversity, beta diversity, and relative abundance of key bacterial taxa) in patients undergoing Roux-en-Y gastric bypass (RYGB) surgery, assessed using 16S rRNA gene sequencing (short-read and full-length), compared with the Obese Control and Healthy Control groups.
Measured: from enrollment up to 12 months of follow-up
Secondary outcomes (3)
Comparison of Short- and Long-Read 16S Sequencing
Compare the performance of short-read (V3-V4) and long-read (full-length 16S rRNA) sequencing technologies in terms of taxonomic resolution and biomarker identification.
Measured: from enrollment up to 12 months of follow-up
Fecal Metabolome Changes and Predictive Microbe-Metabolite Signatures After Bariatric Surgery
Assess changes in the fecal metabolome over time after bariatric surgery and Identify microbe-metabolite signatures predictive of clinical response to bariatric surgery.
Measured: from enrollment up to 12 months of follow-up
Association Between Gut Microbiota and Clinical Outcomes
Analyze the association between gut microbiota changes and clinical/metabolic parameters (weight loss, comorbidities, inflammatory and intestinal permeability markers)
Measured: from enrollment up to 12 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obese PatientsStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Domenica Mallardi, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381140
- Sponsor's protocol ID
- RC2026-30
- Acronym
- RYGB-MICROGUT
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang T, Li H, Ma S, Cao J, Liao H, Huang Q, Chen W. The newest Oxford Nanopore R10.4.1 full-length 16S rRNA sequencing enables the accurate resolution of species-level microbial community profiling. Appl Environ Microbiol. 2023 Oct 31;89(10):e0060523. doi: 10.1128/aem.00605-23. Epub 2023 Oct 6.
PubMed 37800969Oehler JB, Wright H, Stark Z, Mallett AJ, Schmitz U. The application of long-read sequencing in clinical settings. Hum Genomics. 2023 Aug 8;17(1):73. doi: 10.1186/s40246-023-00522-3.
PubMed 37553611Salazar N, Ponce-Alonso M, Garriga M, Sanchez-Carrillo S, Hernandez-Barranco AM, Redruello B, Fernandez M, Botella-Carretero JI, Vega-Pinero B, Galeano J, Zamora J, Ferrer M, de Los Reyes-Gavilan CG, Del Campo R. Fecal Metabolome and Bacterial Composition in Severe Obesity: Impact of Diet and Bariatric Surgery. Gut Microbes. 2022 Jan-Dec;14(1):2106102. doi: 10.1080/19490976.2022.2106102.
PubMed 35903014Palleja A, Kashani A, Allin KH, Nielsen T, Zhang C, Li Y, Brach T, Liang S, Feng Q, Jorgensen NB, Bojsen-Moller KN, Dirksen C, Burgdorf KS, Holst JJ, Madsbad S, Wang J, Pedersen O, Hansen T, Arumugam M; New Collective Author. Roux-en-Y gastric bypass surgery of morbidly obese patients induces swift and persistent changes of the individual gut microbiota. Genome Med. 2016 Jun 15;8(1):67. doi: 10.1186/s13073-016-0312-1.
PubMed 27306058De Luca M, Shikora S, Eisenberg D, Angrisani L, Parmar C, Alqahtani A, Aminian A, Aarts E, Brown W, Cohen RV, Di Lorenzo N, Faria SL, Goodpaster KPS, Haddad A, Herrera M, Rosenthal R, Himpens J, Iossa A, Kermansaravi M, Kow L, Kurian M, Chiappetta S, LaMasters T, Mahawar K, Merola G, Nimeri A, O'Kane M, Papasavas P, Piatto G, Ponce J, Prager G, Pratt JSA, Rogers AM, Salminen P, Steele KE, Suter M, Tolone S, Vitiello A, Zappa M, Kothari SN. Scientific Evidence for the Updated Guidelines on Indications for Metabolic and Bariatric Surgery (IFSO/ASMBS). Obes Surg. 2024 Nov;34(11):3963-4096. doi: 10.1007/s11695-024-07370-7. Epub 2024 Sep 25.
PubMed 39320627
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Gut Microbiota and Fecal Metabolome Following Roux-en-Y Gastric Bypass: Clinical Implications and Identification of Predictive Biomarkers
- ClinicalTrials.gov ID
- NCT07381140
- Acronym / sponsor ID
- RYGB-MICROGUT / RC2026-30
- Conditions
- Obese Patients, Obese Patients With Bariatric Surgery, Gut Microbiota, Healthy Participants
- Keywords
- gut microbiota, stool metabolome, obesity, bariatric surgery, Roux-en-Y gastric bypass, Long-read sequencing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 2 Feb 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.
The goal of this observational study is to learn how bariatric surgery affects gut bacteria and gut-related metabolic products over time in adults with obesity. The study includes adults aged 18 to 65 years who are undergoing Roux-en-Y gastric bypass (RYGB) surgery, as well as adults with obesity treated with diet alone and healthy normal-weight adults.
The main questions it aims to answer are:
How does bariatric surgery change the composition and diversity of gut bacteria over time? How are these changes related to weight loss and improvement of obesity-related health conditions?
Researchers will compare people undergoing bariatric surgery with people with obesity treated with diet alone and with healthy normal-weight individuals to see if surgery leads to specific changes in gut bacteria and stool metabolites that are linked to better clinical outcomes.
Participants will:
Provide stool samples at scheduled time points over 12 months Provide blood samples and undergo routine clinical assessments Take part in follow-up visits to monitor weight, metabolic health, and gastrointestinal symptoms
Detailed description
Obesity is a complex and multifactorial condition associated with metabolic, inflammatory, and gastrointestinal alterations. In recent years, the gut microbiota has emerged as a key factor involved in energy balance, metabolic regulation, and systemic inflammation. Alterations in gut microbial composition and function have been consistently observed in individuals with obesity and are thought to contribute to metabolic dysfunction.
Bariatric surgery, particularly Roux-en-Y gastric bypass (RYGB), is one of the most effective treatments for severe obesity and its related comorbidities. Beyond weight loss, this procedure induces profound changes in gastrointestinal anatomy and nutrient flow, which may significantly influence the gut microbiota and the metabolites it produces. However, the timing, persistence, and clinical relevance of these microbial and metabolic changes over the long term are not yet fully understood.
This prospective observational study is designed to evaluate longitudinal changes in gut microbiota composition and fecal metabolome following bariatric surgery and to explore their association with clinical and metabolic outcomes. Participants undergoing bariatric surgery will be followed over a 12-month period and compared with individuals with obesity receiving dietary treatment and with healthy normal-weight individuals. This comparative approach allows the identification of changes specifically related to surgery rather than to weight loss alone or to normal temporal variability.
Gut microbiota will be analyzed using DNA-based sequencing approaches, while fecal metabolites will be assessed to capture functional changes in microbial activity. These biological data will be integrated with clinical and laboratory parameters to explore relationships between gut-related changes and outcomes such as weight loss, metabolic improvement, inflammation, and intestinal barrier function.
By providing a longitudinal and integrated view of gut microbiota and metabolome remodeling after bariatric surgery, this study aims to improve understanding of the biological mechanisms underlying surgical outcomes and to support the identification of potential biomarkers that may help predict individual responses and guide more personalized approaches to obesity management.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RYGB Group | – | –Adults aged 18-65 years with severe obesity (BMI ≥ 35 kg/m² with comorbidities or BMI ≥ 40 kg/m²) who are undergoing Roux-en-Y gastric bypass (RYGB) surgery. |
| Obese Control Group | – | –Adults aged 18-65 years with obesity (BMI ≥ 30 kg/m²) who are receiving structured dietary treatment without surgery. |
| Healthy Control Group | – | –Adults aged 18-65 years with normal weight (BMI 18.5-24.9 kg/m²) and normal metabolic function. This group helps identify normal variations in gut bacteria and metabolites over time, independent of obesity or surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obese subjects attending the clinical nutrition outpatient clinic of the IRCCS "Saverio de Bellis" - Castellana Grotte (BA).
Key inclusion criteria (17 listed)
- Age between 18 and 65 years.
- Adults with a body mass index (BMI) ≥ 35 kg/m² with related comorbidities, or BMI ≥ 40 kg/m², who are candidates for Roux-en-Y gastric bypass (RYGB) surgery only.
- Age between 18 and 65 years.
- Adults with BMI ≥ 30 kg/m² who are candidates for structured dietary treatment.
- Age between 18 and 65 years.
Key exclusion criteria (7 listed)
- Treatment with antibiotics within the last 3 weeks, or probiotics/prebiotics within the last 4-6 weeks, or systemic corticosteroids within the 8 weeks prior to baseline (T0).
- Participation in dietary regimens or calorie restriction programs in the weeks prior to enrollment.
- Chronic inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis), ongoing enteric infections, or active neoplasms.
- Previous organ transplant or ongoing systemic immunosuppressive therapy.
- Pregnancy or breastfeeding.
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
Long-Term Changes in Gut Microbiota After Bariatric Surgery
Time frame: from enrollment up to 12 months of follow-up
Longitudinal changes in the composition and diversity of the gut microbiota (alpha diversity, beta diversity, and relative abundance of key bacterial taxa) in patients undergoing Roux-en-Y gastric bypass (RYGB) surgery, assessed using 16S rRNA gene sequencing (short-read and full-length), compared with the Obese Control and Healthy Control groups.
3 secondary outcomes
Comparison of Short- and Long-Read 16S Sequencing
Time frame: from enrollment up to 12 months of follow-up
Fecal Metabolome Changes and Predictive Microbe-Metabolite Signatures After Bariatric Surgery
Time frame: from enrollment up to 12 months of follow-up
Association Between Gut Microbiota and Clinical Outcomes
Time frame: from enrollment up to 12 months of follow-up
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 5 Feb 2026.
- Background: PubMed 37800969Zhang T, Li H, Ma S, Cao J, Liao H, Huang Q, Chen W. The newest Oxford Nanopore R10.4.1 full-length 16S rRNA sequencing enables the accurate resolution of species-level microbial community profiling. Appl Environ Microbiol. 2023 Oct 31;89(10):e0060523. doi: 10.1128/aem.00605-23. Epub 2023 Oct 6.
- Background: PubMed 37553611Oehler JB, Wright H, Stark Z, Mallett AJ, Schmitz U. The application of long-read sequencing in clinical settings. Hum Genomics. 2023 Aug 8;17(1):73. doi: 10.1186/s40246-023-00522-3.
- Background: PubMed 35903014Salazar N, Ponce-Alonso M, Garriga M, Sanchez-Carrillo S, Hernandez-Barranco AM, Redruello B, Fernandez M, Botella-Carretero JI, Vega-Pinero B, Galeano J, Zamora J, Ferrer M, de Los Reyes-Gavilan CG, Del Campo R. Fecal Metabolome and Bacterial Composition in Severe Obesity: Impact of Diet and Bariatric Surgery. Gut Microbes. 2022 Jan-Dec;14(1):2106102. doi: 10.1080/19490976.2022.2106102.
- Background: PubMed 27306058Palleja A, Kashani A, Allin KH, Nielsen T, Zhang C, Li Y, Brach T, Liang S, Feng Q, Jorgensen NB, Bojsen-Moller KN, Dirksen C, Burgdorf KS, Holst JJ, Madsbad S, Wang J, Pedersen O, Hansen T, Arumugam M; New Collective Author. Roux-en-Y gastric bypass surgery of morbidly obese patients induces swift and persistent changes of the individual gut microbiota. Genome Med. 2016 Jun 15;8(1):67. doi: 10.1186/s13073-016-0312-1.
- Background: PubMed 39320627De Luca M, Shikora S, Eisenberg D, Angrisani L, Parmar C, Alqahtani A, Aminian A, Aarts E, Brown W, Cohen RV, Di Lorenzo N, Faria SL, Goodpaster KPS, Haddad A, Herrera M, Rosenthal R, Himpens J, Iossa A, Kermansaravi M, Kow L, Kurian M, Chiappetta S, LaMasters T, Mahawar K, Merola G, Nimeri A, O'Kane M, Papasavas P, Piatto G, Ponce J, Prager G, Pratt JSA, Rogers AM, Salminen P, Steele KE, Suter M, Tolone S, Vitiello A, Zappa M, Kothari SN. Scientific Evidence for the Updated Guidelines on Indications for Metabolic and Bariatric Surgery (IFSO/ASMBS). Obes Surg. 2024 Nov;34(11):3963-4096. doi: 10.1007/s11695-024-07370-7. Epub 2024 Sep 25.
- 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.
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 Obese Patients and Obese Patients With Bariatric Surgery, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis 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 17 inclusion and 7 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 5 Feb 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 Domenica Mallardi, Biologist (+390804994129, domenica.mallardi@irccsdebellis.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-Term Changes in Gut Microbiota After Bariatric Surgery (time frame: from enrollment up to 12 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07381140, which also lists 5 linked publications.
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 5 Feb 2026.